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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01HD047709 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Exercise is one of the primary interventions used with people with chronic, mechanical low back pain. It is unknown, however, which exercise is best for which person, which exercises a person will adhere to and for how long, and the effect of adhering to a specific type of exercise on how the person functions, particularly in the long run. The purpose of this study is to examine if the short- and long-term effects are different between 1) commonly prescribed strength and flexibility exercises for the trunk and limbs, and 2) individualized practice in daily functional activities that are difficult or painful to perform. Adherence to the different interventions, the relationship between adherence and outcomes,as well as the effect of a booster intervention also will be examined.
For many people, mechanical low back pain (LBP) is a long-term, function-limiting condition rather than a short-term, self-limiting condition. Exercise is one of the primary non-surgical approaches used worldwide for managing LBP. Specifically in people with chronic LBP, exercise has been found to be as efficacious, if not more efficacious than 1) no treatment, 2) usual care, and 3) many other treatments, such as massage or laser therapy. Despite the growing body of evidence for the beneficial effects of exercise, however, there is limited evidence about 1) which exercise is best for which person, 2) how long the effects of different exercises last, 3) which types of exercise people will adhere to, and for how long, and 4) the mechanisms underlying the effects of different types of exercise.
This study aims to address these limitations by directly comparing the effects of 1) exercise to increase strength of the trunk and increase flexibility of the trunk and extremities, and 2) individualized, motor skill training directed at performance of daily functional activities that are painful or limited due to the person's LBP. This study also will examine 1) the effects of a booster phase of intervention, 2) the relationship between adherence to intervention and function, and 3) the relationship between performance of functional activities and function-related outcomes. People with chronic LBP will be randomized to 1) an intervention of strength and flexibility exercise or motor skill training, and 2) a booster or no-booster intervention. Intervention will be provided in 2 phases: 1) initial phase: 6 - 1 hour sessions, once/week for 6 weeks, and 2) booster phase: # of sessions needed to regain independence in home program, beginning 6 months after the initial phase. The investigators will collect 1) measurements of pain, function, disability, and economic outcomes, 2) reports of adherence, and 3) laboratory-based measures of performance of functional activities. People will be followed for 12 months after the initial intervention phase. Three sets of hypotheses are proposed. First, the investigators hypothesize that both interventions will result in improvements in pain, function, disability, and economic outcomes, but that the motor skill training will result in more long lasting improvements than the strength and flexibility exercise. Second, the investigators hypothesize that the effect of a booster phase of intervention will 1) result in longer lasting improvement in function and better adherence than a no-booster intervention, and 2) be greater for motor skill training than for strength and flexibility exercise. Finally, the investigators hypothesize that 1) adherence to motor skill training will be more strongly related to function than will adherence to strength and flexibility exercise, and 2) performance of functional activities by people receiving motor skill training will be more strongly related to function than performance of functional activities by people receiving strength and flexibility exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motor skill training | Experimental | The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain. |
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| Strength and flexibility exercise | Active Comparator | The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motor skill training | Behavioral | The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment will be provided as needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Oswestry Disability Questionnaire (0-100%) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: The 10-item Modified Oswestry Disability Questionnaire is a disease-specific measure that provides an index of a participant's perceived low back pain-related functional limitation. Procedure: Participants will answer each of the 10 questions by placing a mark in the one box that best describes his current condition. Since a participant may feel that 2 of the statements describe his condition, he is instructed to mark only the box that most closely describes his current condition. Scoring: Each item is given a value from 0-5. The total score is the sum of all questions divided by 50, multiplied by 100 to get a percent. 100 represents the highest level of limitation. | Baseline, completion of initial 6 week intervention phase |
| Change in Modified Oswestry Disability Questionnaire (0-100%) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: The 10-item Modified Oswestry Disability Questionnaire is a disease-specific measure that provides an index of a participant's perceived low back pain-related functional limitation. Procedure: Participants will answer each of the 10 questions by placing a mark in the one box that best describes his current condition. Since a participant may feel that 2 of the statements describe his condition, he is instructed to mark only the box that most closely describes his current condition. Scoring: Each item is given a value from 0-5. The total score is the sum of all questions divided by 50, multiplied by 100 to get a percent. 100 represents the highest level of limitation. | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
| Change in Modified Oswestry Disability Questionnaire (0-100%) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: The 10-item Modified Oswestry Disability Questionnaire is a disease-specific measure that provides an index of a participant's perceived low back pain-related functional limitation. Procedure: Participants will answer each of the 10 questions by placing a mark in the one box that best describes his current condition. Since a participant may feel that 2 of the statements describe his condition, he is instructed to mark only the box that most closely describes his current condition. Scoring: Each item is given a value from 0-5. The total score is the sum of all questions divided by 50, multiplied by 100 to get a percent. 100 represents the highest level of limitation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Numeric Pain Rating Scale (0-10) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to give the therapist information on the intensity of a participant's LBP symptoms. Procedure: Participants will rate their LBP symptoms on a numeric scale of 0-10 where 0 represents no symptoms and 10 represents symptoms as bad as can be. They will rate their average symptoms over the prior 7 days, and worst symptoms over the prior 7 days. Scoring: The score for each item is the rating the participant provides for each symptom category (average and worst). |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Home Program (0-100%) at Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to provide information about how often a participant performs his treatment as it was prescribed. Procedure: Participants will use a VAS to indicate for each day the percentage of the treatment they were able to perform as prescribed. At each clinic visit the therapist will ask the participant to provide an estimate of the average percentage of the treatment he was able to perform as prescribed in the interval of time between 2 clinic visits. Scoring: Average adherence is calculated by averaging the participants' daily adherence. Scores range from 0-100%. Higher values indicate higher adherence to treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda R Van Dillen, P.T., Ph.D. | Program in Physical Therapy, Washington University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63018-2212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36106673 | Derived | Lanier VM, Lohse KR, Hooker QL, Francois SJ, van Dillen LR. Treatment preference changes after exposure to treatment in adults with chronic low back pain. PM R. 2023 Jul;15(7):817-827. doi: 10.1002/pmrj.12897. Epub 2022 Oct 24. | |
| 33369625 | Derived | van Dillen LR, Lanier VM, Steger-May K, Wallendorf M, Norton BJ, Civello JM, Czuppon SL, Francois SJ, Roles K, Lang CE. Effect of Motor Skill Training in Functional Activities vs Strength and Flexibility Exercise on Function in People With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Neurol. 2021 Apr 1;78(4):385-395. doi: 10.1001/jamaneurol.2020.4821. |
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Recruitment was by way of flyers placed in the community and physician offices, ads and interviews through local media and clinics in the region. Recruitment spanned December 2013 to August 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Motor Skill Training | The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain. Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed. |
| FG001 | Strength and Flexibility Exercise | The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions. Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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N=149; five participants (3=MST, 2=SF) excluded from analysis due to only have a baseline time point.
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| ID | Title | Description |
|---|---|---|
| BG000 | Motor Skill Training | The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain. Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Modified Oswestry Disability Questionnaire (0-100%) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: The 10-item Modified Oswestry Disability Questionnaire is a disease-specific measure that provides an index of a participant's perceived low back pain-related functional limitation. Procedure: Participants will answer each of the 10 questions by placing a mark in the one box that best describes his current condition. Since a participant may feel that 2 of the statements describe his condition, he is instructed to mark only the box that most closely describes his current condition. Scoring: Each item is given a value from 0-5. The total score is the sum of all questions divided by 50, multiplied by 100 to get a percent. 100 represents the highest level of limitation. | Data available at the time points | Posted | Mean | Standard Deviation | score on a scale | Baseline, completion of initial 6 week intervention phase |
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Study recruitment began in December of 2013 and all study participation ended November of 2017 therefore any adverse event data would be collected between those study time points. Participation for any given individuals was approximately 14 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Motor Skill Training | The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain. Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Related to Treatment: Ductal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Specific Adverse Event Terms were not used |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Related to Treatment: Worsening of symptoms | Musculoskeletal and connective tissue disorders | Systematic Assessment | An increase in the intensity of low back pain symptoms or peripheralization of symptoms that lasts for greater than 4 hours and has not fully resolved after 24 hours. Not associated with treatment. Systematic assessment during treatment phase. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda van Dillen, PT, PhD, FAPTA; Research Division Director | Washington University | 314-286-1427 | vandillenl@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2019 | May 7, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Strength and flexibility exercise | Behavioral | Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed. |
|
| 6 months after initial intervention phase, 12 months after initial intervention phase |
| Baseline, completion of initial 6 week intervention phase |
| Change in Numeric Pain Rating Scale (0-10) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to give the therapist information on the intensity of a participant's LBP symptoms. Procedure: Participants will rate their LBP symptoms on a numeric scale of 0-10 where 0 represents no symptoms and 10 represents symptoms as bad as can be. They will rate their average symptoms over the prior 7 days, and worst symptoms over the prior 7 days. Scoring: The score for each item is the rating the participant provides for each symptom category (average and worst). | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
| Change in Numeric Pain Rating Scale (0-10) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to give the therapist information on the intensity of a participant's LBP symptoms. Procedure: Participants will rate their LBP symptoms on a numeric scale of 0-10 where 0 represents no symptoms and 10 represents symptoms as bad as can be. They will rate their average symptoms over the prior 7 days, and worst symptoms over the prior 7 days. Scoring: The score for each item is the rating the participant provides for each symptom category (average and worst). | 6 months after initial intervention phase, 12 months after initial intervention phase |
| Change in Number of Acute Flare-ups of Low Back Pain (#) in Past 6 Months, From Baseline to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to give the therapist information about the history of a participant's LBP flare-ups in the past 6 months. Definition: A flare-up is an increase in symptoms of at least 2 points on the NRS above a person's typical low back pain and lasts for at least 2 consecutive days Procedure: Participants will fill in information on how many acute flare-ups they have had over the past 6 months. Scoring: The score will be the number the participant provides for the number of acute flare-ups over the last 6 months. | Baseline, 6 months after initial intervention phase |
| Change in Number of Acute Flare-ups of Low Back Pain (#) in Past 6 Months, From 6 Months After the Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to give the therapist information about the history of a participant's LBP flare-ups in the past 6 months. Definition: A flare-up is an increase in symptoms of at least 2 points on the NRS above a person's typical low back pain and lasts for at least 2 consecutive days Procedure: Participants will fill in information on how many acute flare-ups they have had over the past 6 months. Scoring: The score will be the number the participant provides for the number of acute flare-ups over the last 6 months. | 6 months after initial intervention phase, 12 months after initial intervention phase |
| Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to provide general information on the use of medication for a participant's LBP. Procedure: Participants will answer each question by marking if they are taking non-prescription medication and prescription medication for their LBP. Reported as number of participants currently using medication for LBP. | Baseline, completion of initial 6 week intervention phase |
| Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to provide general information on the use of medication for a participant's LBP. Procedure: Participants will answer each question by marking if they are taking non-prescription medication and prescription medication for their LBP. Reported as number of participants currently using medication for LBP. | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
| Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From 6 Months After Completion of Initial Intervention Phase to 12 Months After Completion of Initial Intervention Phase | Background/Purpose: This questionnaire is designed to provide general information on the use of medication for a participant's LBP. Procedure: Participants will answer each question by marking if they are taking non-prescription medication and prescription medication for their LBP. Reported as number of participants currently using medication for LBP. | 6 months after initial intervention phase, 12 months after initial intervention phase |
| Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to assess the number of days a participant has been kept from his usual activities (work, school or housework) because of LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Reported as the number of participants who reported absenteeism from usual activities over the past 4 weeks. | Baseline, completion of initial 6 week intervention phase |
| Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess the number of days a participant has been kept from his usual activities (work, school or housework) because of LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Reported as the number of participants who reported absenteeism from usual activities over the past 4 weeks. | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
| Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess the number of days a participant has been kept from his usual activities (work, school or housework) because of LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Reported as the number of participants who reported absenteeism from usual activities over the past 4 weeks. | 6 months after initial intervention phase, 12 months after initial intervention phase |
| Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to assess how a participant's LBP affected his participation in usual activities and the impact of LBP on his ability to do his job over the past 4 weeks. Scoring: A Work Impairment Score (WIS) is calculated as the sum of answers on the questions regarding how LBP has affected job ability over the past 4 weeks. Each of the WIS questions is ranked on a 5-point Likert scale. All scores are 1-5, with questions 2, 5, 6, 8, and 10 reverse scored (5-1). The score ranges from 10-50 with 50 indicating the highest degree of impairment. | Baseline, completion of initial 6 week intervention phase |
| Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess how a participant's LBP affected his participation in usual activities and the impact of LBP on his ability to do his job over the past 4 weeks. Scoring: A Work Impairment Score (WIS) is calculated as the sum of answers on the questions regarding how LBP has affected job ability over the past 4 weeks. Each of the WIS questions is ranked on a 5-point Likert scale. All scores are 1-5, with questions 2, 5, 6, 8, and 10 reverse scored (5-1). The score ranges from 10-50 with 50 indicating the highest degree of impairment. | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
| Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess how a participant's LBP affected his participation in usual activities and the impact of LBP on his ability to do his job over the past 4 weeks. Scoring: A Work Impairment Score (WIS) is calculated as the sum of answers on the questions regarding how LBP has affected job ability over the past 4 weeks. Each of the WIS questions is ranked on a 5-point Likert scale. All scores are 1-5, with questions 2, 5, 6, 8, and 10 reverse scored (5-1). The score ranges from 10-50 with 50 indicating the highest degree of impairment. | 6 months after initial intervention phase, 12 months after initial intervention phase |
| Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health. | Baseline, completion of initial 6 week intervention phase |
| Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health. | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
| Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health. | 6 months after initial intervention phase, 12 months after initial intervention phase |
| Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health. | Baseline, completion of initial 6 week intervention phase |
| Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health. | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
| Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health. | 6 months after initial intervention phase, 12 months after initial intervention phase |
| Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to provide general information on the use of additional treatments for a participant's LBP. Health Professional Care Seeking Procedure: Participants will answer each question by marking yes or no for a list of other healthcare professionals they are seeing for treatment of their LBP. Equipment Use Procedure: Participants will answer each question by marking yes or no for a list of equipment they are using to treat their LBP. Scoring: Reported as the number of participants seeking care from health professionals for LBP or using equipment for LBP. | Baseline, completion of initial 6 week intervention phase |
| Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to provide general information on the use of additional treatments for a participant's LBP. Health Professional Care Seeking Procedure: Participants will answer each question by marking yes or no for a list of other healthcare professionals they are seeing for treatment of their LBP. Equipment Use Procedure: Participants will answer each question by marking yes or no for a list of equipment they are using to treat their LBP. Scoring: Reported as the number of participants seeking care from health professionals for LBP or using equipment for LBP. | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
| Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to provide general information on the use of additional treatments for a participant's LBP. Health Professional Care Seeking Procedure: Participants will answer each question by marking yes or no for a list of other healthcare professionals they are seeing for treatment of their LBP. Equipment Use Procedure: Participants will answer each question by marking yes or no for a list of equipment they are using to treat their LBP. Scoring: Reported as the number of participants seeking care from health professionals for LBP or using equipment for LBP. | 6 months after initial intervention phase, 12 months after initial intervention phase |
| Satisfaction With Care (15-75 Points) | Background/Purpose: This questionnaire assesses information about how satisfied a participant feels with the physical therapist and treatment he was provided. Procedure: Participants will answer each question by marking the answer as indicated. They may only check off one answer per item. Scoring: Each question is ranked on a 5-point Likert scale. All scores are 1-5, with questions 1, 3, 4, 8, 9, 10 and 13 reverse scored (5-1). The total score is the sum of all of the answers (15-75) with higher scores indicating more satisfaction with care. | Completion of initial 6 week intervention phase |
| Change in Kinematics During Functional Activities (Degrees) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: These are laboratory measures of (1) movement of the lumbar region, hips and knees or (2) static alignment of the lumbar region during functional activities. Procedures: Angular data is quantified based on data from retro-reflective markers that are tracked with a 3-dimensional video system while the person performs an activity. Coordinate data from the video system is processed to provide quantification of movement or alignment. The variables of interest are (1) angular excursion in the first 50% of the descent phase for each region or joint during picking up an object and (2) lumbar curvature angle for preferred sitting. For movement, smaller numbers from baseline to post-treatment represent decreased movement of a region or joint. For alignment, larger negative numbers from baseline to post-treatment represent a more extended lumbar region alignment. Measures are obtained at baseline and immediately after a 6-week intervention phase. | Baseline, completion of initial 6 week intervention phase |
| Change in Kinematics During Functional Activities (Degrees) From Completion of Initial 6 Week Intervention Phase to 6 Months After Intervention Phase | Background/Purpose: These are laboratory measures of (1) movement of the lumbar region, hips and knees or (2) static alignment of the lumbar region during functional activities. Procedures: Angular data is quantified based on data from retro-reflective markers that are tracked with a 3-dimensional video system while the person performs an activity. Coordinate data from the video system is processed to provide quantification of movement or alignment. The variables of interest are (1) angular excursion in the first 50% of the descent phase for each region or joint during picking up an object and (2) lumbar curvature angle for preferred sitting. For movement, smaller numbers from baseline to post-treatment represent decreased movement of a region or joint. For alignment, larger negative numbers from baseline to post-treatment represent a more extended lumbar region alignment. Measures are obtained after a 6 week intervention phase and 6 months after intervention. | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
| completion of initial 6 week intervention phase |
| Adherence to Home Program (0-100%) at 6 Months After Completion of Initial Intervention Phase | Background/Purpose: This questionnaire is designed to provide information about how often a participant performs his treatment as it was prescribed. Procedure: Participants will use a VAS to indicate an average percent adherence to performance of the treatment as prescribed over the past month. Scoring: Value (percentage of treatment performed) provided by the participant on each monthly survey. Scores range from 0-100%. Higher values indicate higher adherence to treatment. | 6 months after initial intervention phase |
| Adherence to Home Program (0-100%) at 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to provide information about how often a participant performs his treatment as it was prescribed. Procedure: Participants will use a VAS to indicate an average percent adherence to performance of the treatment as prescribed over the past month. Scoring: Value (percentage of treatment performed) provided by the participant on each monthly survey. Scores range from 0-100%. Higher values indicate higher adherence to treatment. | 12 months after initial intervention phase |
| Change in Fear-Avoidance Beliefs Questionnaire Work Subscale Score (0-42 Points) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42. | Baseline, completion of initial 6 week intervention phase |
| Change in Fear-Avoidance Beliefs Questionnaire Work Subscale Score (0-42 Points) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42. | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
| Change in Fear-Avoidance Beliefs Questionnaire Work Subscale Score (0-42 Points) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42. | 6 months after initial intervention phase, 12 months after initial intervention phase |
| Change in Fear-Avoidance Beliefs Questionnaire Physical Activity Subscale Score (0-24 Points) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42. | Baseline, completion of initial 6 week intervention phase |
| Change in Fear-Avoidance Beliefs Questionnaire Physical Activity Subscale Score (0-24 Points) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42. | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
| Change in Fear-Avoidance Beliefs Questionnaire Physical Activity Subscale Score (0-24 Points) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42. | 6 months after initial intervention phase, 12 months after initial intervention phase |
| Treatment Preference Assessment Measure, Effectiveness Subscale (0-4 Points) | Background/Purpose: This questionnaire is designed to provide information about a participant's treatment preferences and the participant's perceptions of four attributes of each treatment: effectiveness, acceptability, suitability/appropriateness, and convenience. The questionnaire is modified from a preference questionnaire designed by Sidani et al to reflect the treatments provided in the trial. Procedure: The two treatment descriptions will be given in a random order to each participant. Scoring: The four treatment attributes (effectiveness, acceptability, suitability/appropriateness, and convenience) will be rated on a 5-point Likert scale (0-4). The anchors are not at all (rating=0) and very much (rating=4). | Baseline |
| Treatment Preference Assessment Measure, Acceptability Subscale (0-4 Points) | Background/Purpose: This questionnaire is designed to provide information about a participant's treatment preferences and the participant's perceptions of four attributes of each treatment: effectiveness, acceptability, suitability/appropriateness, and convenience. The questionnaire is modified from a preference questionnaire designed by Sidani et al to reflect the treatments provided in the trial. Procedure: The two treatment descriptions will be given in a random order to each participant. Scoring: The four treatment attributes (effectiveness, acceptability, suitability/appropriateness, and convenience) will be rated on a 5-point Likert scale (0-4). The anchors are not at all (rating=0) and very much (rating=4). | Baseline |
| Treatment Preference Assessment Measure, Suitability/Appropriateness Subscale (0-4 Points) | Background/Purpose: This questionnaire is designed to provide information about a participant's treatment preferences and the participant's perceptions of four attributes of each treatment: effectiveness, acceptability, suitability/appropriateness, and convenience. The questionnaire is modified from a preference questionnaire designed by Sidani et al to reflect the treatments provided in the trial. Procedure: The two treatment descriptions will be given in a random order to each participant. Scoring: The four treatment attributes (effectiveness, acceptability, suitability/appropriateness, and convenience) will be rated on a 5-point Likert scale (0-4). The anchors are not at all (rating=0) and very much (rating=4). | Baseline |
| Treatment Preference Assessment Measure, Convenience Subscale (0-4 Points) | Background/Purpose: This questionnaire is designed to provide information about a participant's treatment preferences and the participant's perceptions of four attributes of each treatment: effectiveness, acceptability, suitability/appropriateness, and convenience. The questionnaire is modified from a preference questionnaire designed by Sidani et al to reflect the treatments provided in the trial. Procedure: The two treatment descriptions will be given in a random order to each participant. Scoring: The four treatment attributes (effectiveness, acceptability, suitability/appropriateness, and convenience) will be rated on a 5-point Likert scale (0-4). The anchors are not at all (rating=0) and very much (rating=4). | Baseline |
| Change in Direct and Indirect Health Care Costs (Estimated Costs) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: These are measures of costs associated with healthcare over the intervention phase. Procedure: Direct health costs will be estimates of the cost of (1) medication using average wholesale price and wholesale acquisition cost and (2) health services and medical equipment using the Medicare allowable cost. Indirect health costs will be estimated using absenteeism and presenteeism measures. | Baseline, completion of initial 6 week intervention phase |
| Change in Direct and Indirect Healthcare Costs (Estimated Costs) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: These are measures of costs associated with healthcare from completion of the initial 6 week intervention phase to 6 months after the initial intervention phase.. Procedure: Direct health costs will be estimates of the cost of (1) medication using average wholesale price and wholesale acquisition cost and (2) health services and medical equipment using the Medicare allowable cost. Indirect health costs will be estimated using absenteeism and presenteeism measures. | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
| Change in Direct and Indirect Healthcare Costs (Estimated Costs) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: These are measures of costs associated with healthcare from 6 months after the initial intervention phase to 12 months after the initial intervention phase. Procedure: Direct health costs will be estimates of the cost of (1) medication using average wholesale price and wholesale acquisition cost and (2) health services and medical equipment using the Medicare allowable cost. Indirect health costs will be estimated using absenteeism and presenteeism measures. | 6 months after initial intervention phase, 12 months after initial intervention phase |
| 29852151 | Derived | Francois SJ, Lanier VM, Marich AV, Wallendorf M, Van Dillen LR. A Cross-Sectional Study Assessing Treatment Preference of People With Chronic Low Back Pain. Arch Phys Med Rehabil. 2018 Dec;99(12):2496-2503. doi: 10.1016/j.apmr.2018.04.027. Epub 2018 May 28. |
| BG001 | Strength and Flexibility Exercise | The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions. Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Married or living with significant other | Count of Participants | Participants |
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| Completed at least some college | Count of Participants | Participants |
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| Employment situation | Count of Participants | Participants |
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| Low Back Pain Classification | Count of Participants | Participants |
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| Duration of Low Back Pain | Median | Inter-Quartile Range | years |
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| Symptoms only in the back | Count of Participants | Participants |
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| Fear-Avoidance Beliefs Questionnaire - Physical Activity Subscale Score | Assess a participant's fear of pain and beliefs about how physical activity affects his low back pain. The physical activity subscale score ranges from 0-24 with higher scores indicating higher fear-avoidance beliefs about physical activity. | Mean | Standard Deviation | units on a scale |
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| Fear-Avoidance Beliefs Questionnaire - Work Subscale Score | Assess a participant's fear of pain and beliefs about how work affects his low back pain. The work subscale score ranges from 0-42 with higher scores indicating higher fear-avoidance beliefs about work. | Mean | Standard Deviation | units on a scale |
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| Modified Oswestry Disability Questionnaire | A disease-specific measure that provides an index of a participant's perceived low back pain-related functional limitation. The scale for the Modified Oswestry Disability Questionnaire ranges from 0-100; 100 represents the highest level of limitation. | Mean | Standard Deviation | units on a scale |
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| NRS average pain prior 7 days | Numeric Pain Rating Scale of average pain in the prior 7 days: An 11-point scale (0-10) where participants rate their average low back pain symptoms in the prior 7 days on a numeric scale of 0-10 where 0 represents no symptoms and 10 represents symptoms as bad as can be. | Mean | Standard Deviation | units on a scale |
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| NRS worst pain, prior 7 days | Numeric Pain Rating Scale of worst pain in the prior 7 days: An 11-point scale (0-10) where participants rate their worst low back pain symptoms in the prior 7 days on a numeric scale of 0-10 where 0 represents no symptoms and 10 represents symptoms as bad as can be. | Mean | Standard Deviation | units on a scale |
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The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain. Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed. |
| OG001 | Strength and Flexibility Exercise | The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions. Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed. |
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| Primary | Change in Modified Oswestry Disability Questionnaire (0-100%) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: The 10-item Modified Oswestry Disability Questionnaire is a disease-specific measure that provides an index of a participant's perceived low back pain-related functional limitation. Procedure: Participants will answer each of the 10 questions by placing a mark in the one box that best describes his current condition. Since a participant may feel that 2 of the statements describe his condition, he is instructed to mark only the box that most closely describes his current condition. Scoring: Each item is given a value from 0-5. The total score is the sum of all questions divided by 50, multiplied by 100 to get a percent. 100 represents the highest level of limitation. | Data available at the time points | Posted | Mean | Standard Deviation | score on a scale | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
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| Primary | Change in Modified Oswestry Disability Questionnaire (0-100%) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: The 10-item Modified Oswestry Disability Questionnaire is a disease-specific measure that provides an index of a participant's perceived low back pain-related functional limitation. Procedure: Participants will answer each of the 10 questions by placing a mark in the one box that best describes his current condition. Since a participant may feel that 2 of the statements describe his condition, he is instructed to mark only the box that most closely describes his current condition. Scoring: Each item is given a value from 0-5. The total score is the sum of all questions divided by 50, multiplied by 100 to get a percent. 100 represents the highest level of limitation. | Data available at the time points | Posted | Mean | Standard Deviation | score on a scale | 6 months after initial intervention phase, 12 months after initial intervention phase |
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| Secondary | Change in Numeric Pain Rating Scale (0-10) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to give the therapist information on the intensity of a participant's LBP symptoms. Procedure: Participants will rate their LBP symptoms on a numeric scale of 0-10 where 0 represents no symptoms and 10 represents symptoms as bad as can be. They will rate their average symptoms over the prior 7 days, and worst symptoms over the prior 7 days. Scoring: The score for each item is the rating the participant provides for each symptom category (average and worst). | Data available at the time points | Posted | Mean | Standard Deviation | units on a scale | Baseline, completion of initial 6 week intervention phase |
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| Secondary | Change in Numeric Pain Rating Scale (0-10) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to give the therapist information on the intensity of a participant's LBP symptoms. Procedure: Participants will rate their LBP symptoms on a numeric scale of 0-10 where 0 represents no symptoms and 10 represents symptoms as bad as can be. They will rate their average symptoms over the prior 7 days, and worst symptoms over the prior 7 days. Scoring: The score for each item is the rating the participant provides for each symptom category (average and worst). | Data available at the time points | Posted | Mean | Standard Deviation | units on a scale | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
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| Secondary | Change in Numeric Pain Rating Scale (0-10) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to give the therapist information on the intensity of a participant's LBP symptoms. Procedure: Participants will rate their LBP symptoms on a numeric scale of 0-10 where 0 represents no symptoms and 10 represents symptoms as bad as can be. They will rate their average symptoms over the prior 7 days, and worst symptoms over the prior 7 days. Scoring: The score for each item is the rating the participant provides for each symptom category (average and worst). | Data available at the time points | Posted | Mean | Standard Deviation | units on a scale | 6 months after initial intervention phase, 12 months after initial intervention phase |
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| Secondary | Change in Number of Acute Flare-ups of Low Back Pain (#) in Past 6 Months, From Baseline to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to give the therapist information about the history of a participant's LBP flare-ups in the past 6 months. Definition: A flare-up is an increase in symptoms of at least 2 points on the NRS above a person's typical low back pain and lasts for at least 2 consecutive days Procedure: Participants will fill in information on how many acute flare-ups they have had over the past 6 months. Scoring: The score will be the number the participant provides for the number of acute flare-ups over the last 6 months. | Data available at the time points | Posted | Mean | Standard Deviation | acute flare-ups | Baseline, 6 months after initial intervention phase |
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| Secondary | Change in Number of Acute Flare-ups of Low Back Pain (#) in Past 6 Months, From 6 Months After the Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to give the therapist information about the history of a participant's LBP flare-ups in the past 6 months. Definition: A flare-up is an increase in symptoms of at least 2 points on the NRS above a person's typical low back pain and lasts for at least 2 consecutive days Procedure: Participants will fill in information on how many acute flare-ups they have had over the past 6 months. Scoring: The score will be the number the participant provides for the number of acute flare-ups over the last 6 months. | Data available at the time points | Posted | Mean | Standard Deviation | acute flare-ups | 6 months after initial intervention phase, 12 months after initial intervention phase |
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| Secondary | Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to provide general information on the use of medication for a participant's LBP. Procedure: Participants will answer each question by marking if they are taking non-prescription medication and prescription medication for their LBP. Reported as number of participants currently using medication for LBP. | Data available at the time points | Posted | Count of Participants | Participants | Baseline, completion of initial 6 week intervention phase |
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| Secondary | Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to provide general information on the use of medication for a participant's LBP. Procedure: Participants will answer each question by marking if they are taking non-prescription medication and prescription medication for their LBP. Reported as number of participants currently using medication for LBP. | Data available at the time points | Posted | Count of Participants | Participants | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
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| Secondary | Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From 6 Months After Completion of Initial Intervention Phase to 12 Months After Completion of Initial Intervention Phase | Background/Purpose: This questionnaire is designed to provide general information on the use of medication for a participant's LBP. Procedure: Participants will answer each question by marking if they are taking non-prescription medication and prescription medication for their LBP. Reported as number of participants currently using medication for LBP. | Data available at the time points | Posted | Count of Participants | Participants | 6 months after initial intervention phase, 12 months after initial intervention phase |
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| Secondary | Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to assess the number of days a participant has been kept from his usual activities (work, school or housework) because of LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Reported as the number of participants who reported absenteeism from usual activities over the past 4 weeks. | Data available at the time points | Posted | Count of Participants | Participants | Baseline, completion of initial 6 week intervention phase |
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| Secondary | Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess the number of days a participant has been kept from his usual activities (work, school or housework) because of LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Reported as the number of participants who reported absenteeism from usual activities over the past 4 weeks. | Data available at the time points | Posted | Count of Participants | Participants | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
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| Secondary | Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess the number of days a participant has been kept from his usual activities (work, school or housework) because of LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Reported as the number of participants who reported absenteeism from usual activities over the past 4 weeks. | Data available at the time points | Posted | Count of Participants | Participants | 6 months after initial intervention phase, 12 months after initial intervention phase |
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| Secondary | Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to assess how a participant's LBP affected his participation in usual activities and the impact of LBP on his ability to do his job over the past 4 weeks. Scoring: A Work Impairment Score (WIS) is calculated as the sum of answers on the questions regarding how LBP has affected job ability over the past 4 weeks. Each of the WIS questions is ranked on a 5-point Likert scale. All scores are 1-5, with questions 2, 5, 6, 8, and 10 reverse scored (5-1). The score ranges from 10-50 with 50 indicating the highest degree of impairment. | Data available at the time points | Posted | Mean | Standard Deviation | score on a scale | Baseline, completion of initial 6 week intervention phase |
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| Secondary | Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess how a participant's LBP affected his participation in usual activities and the impact of LBP on his ability to do his job over the past 4 weeks. Scoring: A Work Impairment Score (WIS) is calculated as the sum of answers on the questions regarding how LBP has affected job ability over the past 4 weeks. Each of the WIS questions is ranked on a 5-point Likert scale. All scores are 1-5, with questions 2, 5, 6, 8, and 10 reverse scored (5-1). The score ranges from 10-50 with 50 indicating the highest degree of impairment. | Data available at the time points | Posted | Mean | Standard Deviation | score on a scale | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
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| Secondary | Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess how a participant's LBP affected his participation in usual activities and the impact of LBP on his ability to do his job over the past 4 weeks. Scoring: A Work Impairment Score (WIS) is calculated as the sum of answers on the questions regarding how LBP has affected job ability over the past 4 weeks. Each of the WIS questions is ranked on a 5-point Likert scale. All scores are 1-5, with questions 2, 5, 6, 8, and 10 reverse scored (5-1). The score ranges from 10-50 with 50 indicating the highest degree of impairment. | Data available at the time points | Posted | Mean | Standard Deviation | score on a scale | 6 months after initial intervention phase, 12 months after initial intervention phase |
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| Secondary | Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health. | Data available at the time points | Posted | Mean | Standard Deviation | T-scores | Baseline, completion of initial 6 week intervention phase |
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| Secondary | Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health. | Data available at the time points | Posted | Mean | Standard Deviation | T-scores | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
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| Secondary | Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health. | Data available at the time points | Posted | Mean | Standard Deviation | T-scores | 6 months after initial intervention phase, 12 months after initial intervention phase |
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| Secondary | Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health. | Data available at the time points | Posted | Mean | Standard Deviation | T-scores | Baseline, completion of initial 6 week intervention phase |
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| Secondary | Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health. | Data available at the time points | Posted | Mean | Standard Deviation | T-scores | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
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| Secondary | Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health. | Data available at the time points | Posted | Mean | Standard Deviation | T-scores | 6 months after initial intervention phase, 12 months after initial intervention phase |
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| Secondary | Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to provide general information on the use of additional treatments for a participant's LBP. Health Professional Care Seeking Procedure: Participants will answer each question by marking yes or no for a list of other healthcare professionals they are seeing for treatment of their LBP. Equipment Use Procedure: Participants will answer each question by marking yes or no for a list of equipment they are using to treat their LBP. Scoring: Reported as the number of participants seeking care from health professionals for LBP or using equipment for LBP. | Data available at the time points | Posted | Count of Participants | Participants | Baseline, completion of initial 6 week intervention phase |
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| Secondary | Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to provide general information on the use of additional treatments for a participant's LBP. Health Professional Care Seeking Procedure: Participants will answer each question by marking yes or no for a list of other healthcare professionals they are seeing for treatment of their LBP. Equipment Use Procedure: Participants will answer each question by marking yes or no for a list of equipment they are using to treat their LBP. Scoring: Reported as the number of participants seeking care from health professionals for LBP or using equipment for LBP. | Data available at the time points | Posted | Count of Participants | Participants | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
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| Secondary | Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to provide general information on the use of additional treatments for a participant's LBP. Health Professional Care Seeking Procedure: Participants will answer each question by marking yes or no for a list of other healthcare professionals they are seeing for treatment of their LBP. Equipment Use Procedure: Participants will answer each question by marking yes or no for a list of equipment they are using to treat their LBP. Scoring: Reported as the number of participants seeking care from health professionals for LBP or using equipment for LBP. | Data available at the time points | Posted | Count of Participants | Participants | 6 months after initial intervention phase, 12 months after initial intervention phase |
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| Secondary | Satisfaction With Care (15-75 Points) | Background/Purpose: This questionnaire assesses information about how satisfied a participant feels with the physical therapist and treatment he was provided. Procedure: Participants will answer each question by marking the answer as indicated. They may only check off one answer per item. Scoring: Each question is ranked on a 5-point Likert scale. All scores are 1-5, with questions 1, 3, 4, 8, 9, 10 and 13 reverse scored (5-1). The total score is the sum of all of the answers (15-75) with higher scores indicating more satisfaction with care. | Data available at the time points | Posted | Mean | Standard Deviation | score on a scale | Completion of initial 6 week intervention phase |
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| Secondary | Change in Kinematics During Functional Activities (Degrees) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: These are laboratory measures of (1) movement of the lumbar region, hips and knees or (2) static alignment of the lumbar region during functional activities. Procedures: Angular data is quantified based on data from retro-reflective markers that are tracked with a 3-dimensional video system while the person performs an activity. Coordinate data from the video system is processed to provide quantification of movement or alignment. The variables of interest are (1) angular excursion in the first 50% of the descent phase for each region or joint during picking up an object and (2) lumbar curvature angle for preferred sitting. For movement, smaller numbers from baseline to post-treatment represent decreased movement of a region or joint. For alignment, larger negative numbers from baseline to post-treatment represent a more extended lumbar region alignment. Measures are obtained at baseline and immediately after a 6-week intervention phase. | Data available at the time points | Posted | Mean | 95% Confidence Interval | Angle in degrees | Baseline, completion of initial 6 week intervention phase |
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| Secondary | Change in Kinematics During Functional Activities (Degrees) From Completion of Initial 6 Week Intervention Phase to 6 Months After Intervention Phase | Background/Purpose: These are laboratory measures of (1) movement of the lumbar region, hips and knees or (2) static alignment of the lumbar region during functional activities. Procedures: Angular data is quantified based on data from retro-reflective markers that are tracked with a 3-dimensional video system while the person performs an activity. Coordinate data from the video system is processed to provide quantification of movement or alignment. The variables of interest are (1) angular excursion in the first 50% of the descent phase for each region or joint during picking up an object and (2) lumbar curvature angle for preferred sitting. For movement, smaller numbers from baseline to post-treatment represent decreased movement of a region or joint. For alignment, larger negative numbers from baseline to post-treatment represent a more extended lumbar region alignment. Measures are obtained after a 6 week intervention phase and 6 months after intervention. | Data available at the time points | Posted | Mean | 95% Confidence Interval | Angle in degrees | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
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| Other Pre-specified | Adherence to Home Program (0-100%) at Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to provide information about how often a participant performs his treatment as it was prescribed. Procedure: Participants will use a VAS to indicate for each day the percentage of the treatment they were able to perform as prescribed. At each clinic visit the therapist will ask the participant to provide an estimate of the average percentage of the treatment he was able to perform as prescribed in the interval of time between 2 clinic visits. Scoring: Average adherence is calculated by averaging the participants' daily adherence. Scores range from 0-100%. Higher values indicate higher adherence to treatment. | Data available at this time point | Posted | Mean | Standard Deviation | percentage of adherence to home program | completion of initial 6 week intervention phase |
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| Other Pre-specified | Adherence to Home Program (0-100%) at 6 Months After Completion of Initial Intervention Phase | Background/Purpose: This questionnaire is designed to provide information about how often a participant performs his treatment as it was prescribed. Procedure: Participants will use a VAS to indicate an average percent adherence to performance of the treatment as prescribed over the past month. Scoring: Value (percentage of treatment performed) provided by the participant on each monthly survey. Scores range from 0-100%. Higher values indicate higher adherence to treatment. | Data available at this time point | Posted | Mean | Standard Deviation | percentage of adherence to home program | 6 months after initial intervention phase |
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| Other Pre-specified | Adherence to Home Program (0-100%) at 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to provide information about how often a participant performs his treatment as it was prescribed. Procedure: Participants will use a VAS to indicate an average percent adherence to performance of the treatment as prescribed over the past month. Scoring: Value (percentage of treatment performed) provided by the participant on each monthly survey. Scores range from 0-100%. Higher values indicate higher adherence to treatment. | Data available at this time point | Posted | Mean | Standard Deviation | percentage of adherence to home program | 12 months after initial intervention phase |
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| Other Pre-specified | Change in Fear-Avoidance Beliefs Questionnaire Work Subscale Score (0-42 Points) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42. | Data available at the time points | Posted | Mean | Standard Deviation | score on a scale | Baseline, completion of initial 6 week intervention phase |
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| Other Pre-specified | Change in Fear-Avoidance Beliefs Questionnaire Work Subscale Score (0-42 Points) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42. | Data available at the time points | Posted | Mean | Standard Deviation | score on a scale | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
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| Other Pre-specified | Change in Fear-Avoidance Beliefs Questionnaire Work Subscale Score (0-42 Points) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42. | Data for 12 months after the initial intervention phase were not collected. The decision not to collect 12 month data was made prior to finalization of the protocol and participant enrollment. | Posted | 6 months after initial intervention phase, 12 months after initial intervention phase |
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| Other Pre-specified | Change in Fear-Avoidance Beliefs Questionnaire Physical Activity Subscale Score (0-24 Points) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42. | Data available at the time points | Posted | Mean | Standard Deviation | score on a scale | Baseline, completion of initial 6 week intervention phase |
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| Other Pre-specified | Change in Fear-Avoidance Beliefs Questionnaire Physical Activity Subscale Score (0-24 Points) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42. | Data available at the time points | Posted | Mean | Standard Deviation | score on a scale | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
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| Other Pre-specified | Change in Fear-Avoidance Beliefs Questionnaire Physical Activity Subscale Score (0-24 Points) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42. | Data for 12 months after the initial intervention phase were not collected. The decision not to collect 12 month data was made prior to finalization of the protocol and participant enrollment. | Posted | 6 months after initial intervention phase, 12 months after initial intervention phase |
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| Other Pre-specified | Treatment Preference Assessment Measure, Effectiveness Subscale (0-4 Points) | Background/Purpose: This questionnaire is designed to provide information about a participant's treatment preferences and the participant's perceptions of four attributes of each treatment: effectiveness, acceptability, suitability/appropriateness, and convenience. The questionnaire is modified from a preference questionnaire designed by Sidani et al to reflect the treatments provided in the trial. Procedure: The two treatment descriptions will be given in a random order to each participant. Scoring: The four treatment attributes (effectiveness, acceptability, suitability/appropriateness, and convenience) will be rated on a 5-point Likert scale (0-4). The anchors are not at all (rating=0) and very much (rating=4). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Other Pre-specified | Treatment Preference Assessment Measure, Acceptability Subscale (0-4 Points) | Background/Purpose: This questionnaire is designed to provide information about a participant's treatment preferences and the participant's perceptions of four attributes of each treatment: effectiveness, acceptability, suitability/appropriateness, and convenience. The questionnaire is modified from a preference questionnaire designed by Sidani et al to reflect the treatments provided in the trial. Procedure: The two treatment descriptions will be given in a random order to each participant. Scoring: The four treatment attributes (effectiveness, acceptability, suitability/appropriateness, and convenience) will be rated on a 5-point Likert scale (0-4). The anchors are not at all (rating=0) and very much (rating=4). | Data available at this time point | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Other Pre-specified | Treatment Preference Assessment Measure, Suitability/Appropriateness Subscale (0-4 Points) | Background/Purpose: This questionnaire is designed to provide information about a participant's treatment preferences and the participant's perceptions of four attributes of each treatment: effectiveness, acceptability, suitability/appropriateness, and convenience. The questionnaire is modified from a preference questionnaire designed by Sidani et al to reflect the treatments provided in the trial. Procedure: The two treatment descriptions will be given in a random order to each participant. Scoring: The four treatment attributes (effectiveness, acceptability, suitability/appropriateness, and convenience) will be rated on a 5-point Likert scale (0-4). The anchors are not at all (rating=0) and very much (rating=4). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Other Pre-specified | Treatment Preference Assessment Measure, Convenience Subscale (0-4 Points) | Background/Purpose: This questionnaire is designed to provide information about a participant's treatment preferences and the participant's perceptions of four attributes of each treatment: effectiveness, acceptability, suitability/appropriateness, and convenience. The questionnaire is modified from a preference questionnaire designed by Sidani et al to reflect the treatments provided in the trial. Procedure: The two treatment descriptions will be given in a random order to each participant. Scoring: The four treatment attributes (effectiveness, acceptability, suitability/appropriateness, and convenience) will be rated on a 5-point Likert scale (0-4). The anchors are not at all (rating=0) and very much (rating=4). | Data available at this time point | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Other Pre-specified | Change in Direct and Indirect Health Care Costs (Estimated Costs) From Baseline to Completion of Initial 6 Week Intervention Phase | Background/Purpose: These are measures of costs associated with healthcare over the intervention phase. Procedure: Direct health costs will be estimates of the cost of (1) medication using average wholesale price and wholesale acquisition cost and (2) health services and medical equipment using the Medicare allowable cost. Indirect health costs will be estimated using absenteeism and presenteeism measures. | The exploratory economic analyses we proposed to examine direct (medication and health services use and medical equipment) and indirect (absenteeism and presenteeism) health costs are not to be conducted. The decision was based on large budget cuts that limited our ability to financially support the personnel to conduct the analyses | Posted | Baseline, completion of initial 6 week intervention phase |
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| Other Pre-specified | Change in Direct and Indirect Healthcare Costs (Estimated Costs) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase | Background/Purpose: These are measures of costs associated with healthcare from completion of the initial 6 week intervention phase to 6 months after the initial intervention phase.. Procedure: Direct health costs will be estimates of the cost of (1) medication using average wholesale price and wholesale acquisition cost and (2) health services and medical equipment using the Medicare allowable cost. Indirect health costs will be estimated using absenteeism and presenteeism measures. | The exploratory economic analyses we proposed to examine direct (medication and health services use and medical equipment) and indirect (absenteeism and presenteeism) health costs are not to be conducted. The decision was based on large budget cuts that limited our ability to financially support the personnel to conduct the analyses | Posted | Completion of initial 6 week intervention phase, 6 months after initial intervention phase |
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| Other Pre-specified | Change in Direct and Indirect Healthcare Costs (Estimated Costs) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase | Background/Purpose: These are measures of costs associated with healthcare from 6 months after the initial intervention phase to 12 months after the initial intervention phase. Procedure: Direct health costs will be estimates of the cost of (1) medication using average wholesale price and wholesale acquisition cost and (2) health services and medical equipment using the Medicare allowable cost. Indirect health costs will be estimated using absenteeism and presenteeism measures. | The exploratory economic analyses we proposed to examine direct (medication and health services use and medical equipment) and indirect (absenteeism and presenteeism) health costs are not to be conducted. The decision was based on large budget cuts that limited our ability to financially support the personnel to conduct the analyses | Posted | 6 months after initial intervention phase, 12 months after initial intervention phase |
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| 0 |
| 74 |
| 1 |
| 74 |
| 43 |
| 74 |
| EG001 | Strength and Flexibility Exercise | The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions. Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed. | 0 | 75 | 1 | 75 | 34 | 75 |
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| Non-Related to Treatment: Disc Herniation Surgery | Surgical and medical procedures | Non-systematic Assessment | Specific Adverse Event Terms were not used |
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| Related to Treatment: Worsening of symptoms | Musculoskeletal and connective tissue disorders | Systematic Assessment | An increase in the intensity of low back pain symptoms or peripheralization of symptoms that lasts for greater than 4 hours and has not fully resolved after 24 hours. Associated with treatment. Systematic assessment during treatment phase. |
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| Non-Related to Treatment: non-serious | General disorders | Non-systematic Assessment | Specific Adverse Event Terms were not used |
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Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| Follow-Up Month 12 |
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| Post-Treatment (Average) |
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| Baseline (Worst) |
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| Post-Treatment (Worst) |
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| Post-Treatment (Worst) |
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| Follow-Up Month 6 (Worst) |
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| Follow-Up Month 12 (Average) |
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| Follow-Up Month 6 (Worst) |
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| Follow-Up Month 12 (Worst) |
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| Follow-Up Month 6 |
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| Follow-Up Month 12 |
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| Post-Treatment |
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| Follow-Up Month 6 |
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| Follow-Up Month 12 |
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| Post-Treatment |
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| Follow-Up Month 12 |
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| Post-Treatment |
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| Follow-Up Month 6 |
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| Follow-Up Month 12 |
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| Post-Treatment |
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| Follow-Up Month 6 |
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| Follow-Up Month 12 |
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| Post-Treatment |
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| Follow-Up Month 6 |
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| Follow-Up Month 12 |
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| Post-Treatment (Care Seeking) |
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| Baseline (Equipment Use) |
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| Post-Treatment (Equipment Use) |
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| Post-Treatment (Equipment Use) |
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| Follow-Up Month 6 (Equipment Use) |
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| Follow-Up Month 12 (care seeking) |
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| Follow-Up Month 6 (equipment use) |
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| Follow-Up Month 12 (equipment use) |
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| Post-intervention: Lumbar region |
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| Baseline: Hip joint excursion |
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| Post-intervention: Hip joint excursion |
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| Baseline: Knee joint excursion |
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| Post-intervention: Knee joint excursion |
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| Baseline: Lumbar region curvature |
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| Post-intervention: Lumbar region curvature |
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| 6 months post-intervention: Lumbar excursion |
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| Post-intervention: Hip joint excursion |
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| 6 months post-intervention: Hip joint excursion |
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| Post-intervention: Knee joint excursion |
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| 6 months post intervention: Knee joint excursion |
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| Post-intervention: Lumbar curvature |
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| 6 months post-intervention: Lumbar curvature |
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| Post-Treatment |
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| Follow-Up Month 6 |
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| Follow-Up Month 6 |
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| Follow-Up Month 6 |
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| Acceptability of Strength and Flexibility Exercise |
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| Convenience of Strength and Flexibility Exercise |
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