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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The objective of this study is to improve health care for patients with chronic LBP and increase the likelihood that patients obtain outcomes that matter most to them. The investigators will accomplish our goal using a sequential multiple randomization (SMART) design comparing the effectiveness of Phase 1 (PT v. CBT) treatments for patients with chronic LBP; and among patient non-responsive to Phase I treatment, compare the effectiveness of Phase II treatments (switching to PT or CBT v. mindfulness). Effectiveness will be based on patient-centered outcomes. Sub-aims will compare main effects of Phase 1 and 2 treatment options and the sequencing effects of different treatment combinations.
The study uses a sequential multiple randomization (SMART) design. The study will compare the effectiveness of common first-line treatments for chronic LBP: PT or CBT. Initial treatment will be 8 weeks duration with re-evaluation at 10-weeks after enrollment to allow time to complete treatment. At the 10-week assessment researchers will examine if the patient has responded to initial treatment using a patient-centered, validated definition of successful response based on 50% improvement in the Oswestry Disability Index (ODI). Patients who are responders to initial treatment will receive up to 2 additional sessions of the same treatment to assist transition to self-management. Non-responders will be re-randomized to a second treatment strategy of either switching to the other initial treatment (i.e., patients receiving PT switch to CBT or vice versa), or mindfulness. The second treatment phase is also 8 weeks in duration. Additional follow-ups occur 26- and 52 weeks after enrollment.
The study has two co-primary outcomes; function and pain. The investigators will use the ODI, a well-validated, reliable and responsive patient-reported measure of LBP-related function recommended by the NIH Back Pain Task Force. The investigators will assess pain intensity with 0-10 ratings ('0' indicating no pain and '10' worst imaginable pain). Separate ratings are made for current, worst and best pain over the past 24 hours with an average computed to represent pain intensity. Secondary outcomes will assess dimensions of quality of life, work and healthcare utilization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PT followed by Switching to CBT in Phase II for nonresponders | Experimental | Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will switch to 8 weekly sessions of cognitive behavioral therapy (CBT) as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment. |
|
| PT followed by Mindfulness in Phase II for nonresponders | Experimental | Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will receive 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment. |
|
| CBT followed by Switching to PT in Phase II for nonresponders | Experimental | Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of evidence-based physical therapy (PT) as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment. |
|
| CBT followed by Mindfulness in Phase II for nonresponders |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Therapy | Behavioral | Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oswestry Disability Index From Baseline to 10 Weeks | Back pain specific measure of functional disability to address Aim 1, score range 0-100 with neagtive values representing improvement in disability | baseline, 10 weeks |
| Change in Oswestry Disability Index From 10-weeks to 52 Weeks | Back pain specific measure of functional disability to address Aim 2, score range 0-100 with negative values representing improvement in disability | 10 weeks, 52 weeks |
| Change in Numeric Pain Intensity Rating From Baseline to 10 Weeks | 0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 1. Negative values represent a reduction in pain intensity. | baseline, 10 weeks |
| Change in Numeric Pain Intensity Rating From 10-weeks to 52 Weeks | 0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 2. Negative values represent an improvement in pain intensity. | 10 weeks, 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related Quality of Life | PROMIS-29 subscales scores reported across 7 domains | baseline, 10 weeks, 26 weeks, 52 weeks |
| Change in Pain Interference From Baseline to 10 Weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. negative scores indicate improvement in pain interference. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Fritz, PT, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States | ||
| Intermountain Health Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32393216 | Background | Skolasky RL, Wegener ST, Aaron RV, Ephraim P, Brennan G, Greene T, Lane E, Minick K, Hanley AW, Garland EL, Fritz JM. The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain. BMC Musculoskelet Disord. 2020 May 11;21(1):293. doi: 10.1186/s12891-020-03324-z. | |
| 42008809 |
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A total 751 participants were randomized. Three participants were determined to be false inclusions after randomization. One false inclusion was the result of not meeting the minimum disability threshold for eligibility. This participant continued in the study. The other two false inclusions were persons with medical conditions that were exclusions. These two participants did not participate in the study. Therefore study results are reported for 749 participants.
Trial enrollment began in March, 2019. In March, 2020 the trial suspended enrollments across all sites due to COVID restrictions. Enrollment resumed in April, 2021 and was completed in September, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | PT Followed by Switching to CBT in Phase II for Nonresponders | Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will switch to 8 weekly sessions of cognitive behavioral therapy (CBT) as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment. |
| FG001 | PT Followed by Mindfulness in Phase II for Nonresponders | Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will receive 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment. |
| FG002 | CBT Followed by Switching to PT in Phase II for Nonresponders | Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of evidence-based physical therapy (PT) as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment. |
| FG003 | CBT Followed by Mindfulness in Phase II for Nonresponders | Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment. |
| FG004 | Responder: Phase I PT Treatment Alone | This arm includes participants assigned to PT who respond in Phase I |
| FG005 | Responder: Phase I CBT Treatment Alone | This arm includes participants assigned to CBT who respond in Phase I |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I |
|
| ||||||||||||||||||
| Phase II |
| |||||||||||||||||||
| Long-term Follow-Up |
|
Two participants were determined to be false inclusions after randomization and were not included in the analyses
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I PT Treatment | This arm includes all participants assigned to PT for Phase I treatment |
| BG001 | Phase I CBT Treatment | This arm includes all participants assigned to CBT in Phase I |
| Units | Counts |
|---|---|
| Participants |
|
| 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 Oswestry Disability Index From Baseline to 10 Weeks | Back pain specific measure of functional disability to address Aim 1, score range 0-100 with neagtive values representing improvement in disability | Posted | Mean | Standard Error | Units on a scale | baseline, 10 weeks |
|
Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
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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 | Phase I PT Treatment | This arm includes participants assigned to PT as their Phase I treatment Physical Therapy: Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Surgery | Surgical and medical procedures | Non-systematic Assessment | Lumbar Surgical Procedure |
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Our study has limitations. Treatment initiations rates were low, reducing the treatment dose for participants. COVID caused a suspension of enrollment for 13 months, requiring a reduction in the target sample size. While sufficient power was retained for the co-primary aims, the power for some secondary and exploratory aims was impacted. Finally, our study design did not include a treatment as usual condition for comparison with our study treatments and embedded adaptive interventions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julie Fritz | University of Utah | 801-587-2237 | julie.fritz@utah.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 | Apr 11, 2022 | Feb 26, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D015928 | Cognitive Behavioral Therapy |
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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Not provided
Our design is a sequential multiple randomization (SMART) study design with 2 treatment phases with a possibility of 2 randomizations per participant.
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Participants and clinicians cannot be blind to treatment received. The investigators will remain blind to group assignment and follow-up assessments will be conducted by assessors who are blind to treatment group.
| Experimental |
Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment. |
|
| Phase I PT Treatment | Active Comparator | This arm includes participants assigned to PT as their Phase I treatment |
|
| Phase I CBT Treatment | Active Comparator | This arm includes participants assigned to CBT for their Phase I treatment |
|
| Phase II Switching Treatment | Active Comparator | Includes all Non-Responders in Phase I who were re-randomized to Switch in Phase II |
|
| Phase II Mindfulness Treatment | Active Comparator | Include all Non-Responders in Phase I who were re-randomized to Mindfulness in Phase II |
|
| Cognitive Behavioral Therapy | Behavioral | Evidence-based cognitive behavioral therapy provided in 8 individual sessions focused on key components of CBT; 1) identifying and monitoring maladaptive cognitions, 2) developing coping strategies (e.g., distraction, relaxation, etc.), 3) setting and working towards behavioral goals, especially focused on physical activity, and 4) focusing on self-management skills and home instruction |
|
| Mindfulness | Behavioral | Mindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices. |
|
|
| Phase I Treatment | Behavioral | Includes all participants receiving any Phase I intervention |
|
| Phase II Switching | Behavioral | Includes all participants receiving Switching as Phase II intervention |
|
| baseline, 10 weeks |
| Change in Fatigue From Baseline to !0 Weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. Negative values indicate greater improvement in fatigue. | baseline, 10 weeks |
| Change in Sleep Disturbance From Baseline to 10 Weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in sleep disturbance | baseline, 10 weeks |
| Change in Anxiety From Baseline to 10 Weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29)assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in anxiety | baseline, 10 weeks |
| Change in Depression From Baseline to 10 Weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in depression | baseline, 10 weeks |
| Change in Social Role Participation From Baseline to 10 Weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in the ability to perform social roles | baseline, 10 weeks |
| Health Care Utilization of Advanced Imaging for Back Pain Over 10 Weeks | Use of either MRI or CT for low back pain | baseline, 10 weeks |
| Opioid Utilization at 10-week Assessment | Long-term use of opioids for pain management defined as use on all or most days in the past 90 days | baseline, 10 weeks |
| Treatment Side Effects | Self-reported physical or psychological side effects of study treatments | 10 weeks |
| Treatment Responder | Dichotomous outcome based on achieving at least 50% improvement on ODI from baseline score | baseline, 10 weeks |
| Health Care Utilization of Injections for Back Pain Over 10 Weeks | Use of injections for low back pain | baseline, 10 weeks |
| Health Care Utilization of Radiographs for Back Pain Over 10 Weeks | Use of radiographs for low back pain | baseline, 10 weeks |
| Salt Lake City |
| Utah |
| 84107 |
| United States |
| The University of Utah Healthcare System | Salt Lake City | Utah | 84108 | United States |
| Fritz JM, Skolasky RL, Brennan G, Minick K, Wegener ST, Lane E, Garland EL, Aaron RV, Bardsley T, Fino N, Zhang Y, Shen J, Conroy MB, Hunter S, Hanley A, Thackeray A, Rassu FS, McLaughlin K, Cook D, Greene T. Effectiveness of Nonpharmacologic Treatments for Chronic Low Back Pain : A Sequential, Multiple-Assignment, Randomized Trial. Ann Intern Med. 2026 Jun;179(6):773-784. doi: 10.7326/ANNALS-25-04645. Epub 2026 Apr 21. |
| 36823645 | Derived | Fritz JM, Greene T, Brennan GP, Minick K, Lane E, Wegener ST, Skolasky RL. Characterizing modifications to a comparative effectiveness research study: the OPTIMIZE trial-using the Framework for Reporting Adaptations and Modifications to Evidence-based Interventions (FRAME). Trials. 2023 Feb 23;24(1):137. doi: 10.1186/s13063-023-07150-1. |
| 34927165 | Derived | Fritz JM, Lane E, Minick KI, Bardsley T, Brennan G, Hunter SJ, McGee T, Rassu FS, Wegener ST, Skolasky RL. Perceptions of Telehealth Physical Therapy Among Patients with Chronic Low Back Pain. Telemed Rep. 2021 Nov 3;2(1):258-263. doi: 10.1089/tmr.2021.0028. eCollection 2021. |
| Lost to Follow-up |
|
| COMPLETED | Completed the 26 week follow-up |
|
| NOT COMPLETED |
|
|
| COMPLETED | Completed the 52 week assessment |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Body Mass Index based on height and weight | BMI missing for 6 participants | Mean | Standard Deviation | kg/m2 |
|
| Current Smoker | Self-report of current smoking status | Smoking status was not reported by four participants | Count of Participants | Participants |
|
| Highest Education Level Completed | Four participants did not report education level | Count of Participants | Participants |
|
| Prior Lumbar Spine Surgery | Had Lumbar Spine Surgery At Least One Year Ago | Two participants did not provide prior surgey information | Count of Participants | Participants |
|
| Leg Pain with Back Pain | Has Symptoms Extending Below the Knee Associated With Back Pain | Two participants did not provide leg pain responses | Count of Participants | Participants |
|
| Provided Opioids at Index Healthcare Visit | Provided opioids at the health care visit that made the person eligible for the study | 10 participants did not provide information on opioids at index visit | Count of Participants | Participants |
|
| Duration of Opioid Use at Baseline | Seven participants did not provide opioid use duration information | Count of Participants | Participants |
|
| Time From First Low Back Pain Episode | Two participants did not provide information on duration since first back pain episode | Count of Participants | Participants |
|
| Oswestry Disability Index | Measure of back-pain related functional disability, scores range from 0-100 with higher scores indicating greater disability | Mean | Standard Deviation | units on a scale |
|
| Numeric Pain Intensity Rating | Rating of pain intensity on a 0-10 scale with higher numbers indicating greater pain intensity | Mean | Standard Deviation | units on a scale |
|
| Patient-reported outcomes measurement information system (PROMIS) - pain interference | PROMIS pain interference measure interference with activities due to pain. The score is a T-score with population mean of 50 and standard deviiation of 10. Higher score indicate greater pain interference | 13 participants did not provide a PROMIS pain interference score | Mean | Standard Deviation | T score |
|
| Patient-reported outcomes measurement information system (PROMIS) - physical function | PROMIS physical function measures function. The score is a T-score with population mean of 50 and standard deviiation of 10. Higher score indicate greater physical function | 12 participants did not complete the PROMIS - physical function at baseline | Mean | Standard Deviation | T score |
|
| Patient-reported outcomes measurement information system (PROMIS) - depression | PROMIS depression is reported as a T-score with population mean of 50 and standard deviiation of 10. Higher score indicate greater depression | 4 participants did not complete the PROMIS - depression at baseline | Mean | Standard Deviation | T score |
|
| Patient-reported outcomes measurement information system (PROMIS) - anxiety | PROMIS anxiety is reported as a T-score with population mean of 50 and standard deviiation of 10. Higher score indicate greater anxiety | 9 participants did not complete the PROMIS - anxiety at baseline | Mean | Standard Deviation | T score |
|
| Patient-reported outcomes measurement information system (PROMIS) - social roles | PROMIS social roles measures the ability to engage in social activities. The score is a T-score with population mean of 50 and standard deviiation of 10. Higher score indicate greater ability to engage in social activities | 5 participants did not complete the PROMIS - social roles at baseline | Mean | Standard Deviation | T score |
|
| Patient-reported outcomes measurement information system (PROMIS) - sleep disturbance | PROMIS sleep disturbance measures the level of sleep disturbance. The score is a T-score with population mean of 50 and standard deviiation of 10. Higher score indicate greater amount of sleep disturbance | 11 participants did not complete the PROMIS - sleep disturbance at baseline | Mean | Standard Deviation | T score |
|
| Patient-reported outcomes measurement information system (PROMIS) - fatigue | PROMIS fatigue measures the level of fatigue. The score is a T-score with population mean of 50 and standard deviiation of 10. Higher score indicate greater amount of fatigue | 12 participants did not complete the PROMIS - Fatigue | Mean | Standard Deviation | T score |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | Change in Oswestry Disability Index From 10-weeks to 52 Weeks | Back pain specific measure of functional disability to address Aim 2, score range 0-100 with negative values representing improvement in disability | Note that as specified in the study protocol and statistical analysis plan, non-responders randomized to swtich treatments or to mindfulness are combined across Phase I treatment groups. | Posted | Mean | Standard Error | Units on a scale | 10 weeks, 52 weeks |
|
|
|
|
| Primary | Change in Numeric Pain Intensity Rating From Baseline to 10 Weeks | 0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 1. Negative values represent a reduction in pain intensity. | Posted | Mean | Standard Error | Units on a scale | baseline, 10 weeks |
|
|
|
|
| Primary | Change in Numeric Pain Intensity Rating From 10-weeks to 52 Weeks | 0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 2. Negative values represent an improvement in pain intensity. | Note that as specified in the study protocol and statistical analysis plan, non-responders randomized to swtich treatments or to mindfulness are combined across Phase I treatment groups. | Posted | Mean | Standard Error | Units on a scale | 10 weeks, 52 weeks |
|
|
|
|
| Secondary | Health-related Quality of Life | PROMIS-29 subscales scores reported across 7 domains | Not Posted | baseline, 10 weeks, 26 weeks, 52 weeks | Participants |
| Secondary | Change in Pain Interference From Baseline to 10 Weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. negative scores indicate improvement in pain interference. | Posted | Mean | Standard Error | T score | baseline, 10 weeks |
|
|
|
|
| Secondary | Change in Fatigue From Baseline to !0 Weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. Negative values indicate greater improvement in fatigue. | Posted | Mean | Standard Error | T score | baseline, 10 weeks |
|
|
|
|
| Secondary | Change in Sleep Disturbance From Baseline to 10 Weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in sleep disturbance | Posted | Mean | Standard Error | T score | baseline, 10 weeks |
|
|
|
|
| Secondary | Change in Anxiety From Baseline to 10 Weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29)assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in anxiety | Posted | Mean | Standard Error | T score | baseline, 10 weeks |
|
|
|
|
| Secondary | Change in Depression From Baseline to 10 Weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in depression | Posted | Mean | Standard Error | T score | baseline, 10 weeks |
|
|
|
|
| Secondary | Change in Social Role Participation From Baseline to 10 Weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in the ability to perform social roles | Posted | Mean | Standard Error | T score | baseline, 10 weeks |
|
|
|
|
| Secondary | Health Care Utilization of Advanced Imaging for Back Pain Over 10 Weeks | Use of either MRI or CT for low back pain | All participants included in analyses with multiple imputation for missing data. | Posted | Count of Participants | Participants | No | baseline, 10 weeks |
|
|
|
|
| Secondary | Opioid Utilization at 10-week Assessment | Long-term use of opioids for pain management defined as use on all or most days in the past 90 days | All participants included in analysis with multiple imputation used for missing data | Posted | Count of Participants | Participants | baseline, 10 weeks |
|
|
|
|
| Secondary | Treatment Side Effects | Self-reported physical or psychological side effects of study treatments | Participants analyzed include those who initiated Phase I treatment | Posted | Count of Participants | Participants | 10 weeks |
|
|
|
|
| Secondary | Treatment Responder | Dichotomous outcome based on achieving at least 50% improvement on ODI from baseline score | Analysis population is participants providing a 10-week assessment ODI score | Posted | Count of Participants | Participants | baseline, 10 weeks |
|
|
|
|
| Secondary | Health Care Utilization of Injections for Back Pain Over 10 Weeks | Use of injections for low back pain | All participants included in analyses based on Phase I treatment assignment with multiple imputation for missing data. | Posted | Count of Participants | Participants | No | baseline, 10 weeks |
|
|
|
|
| Secondary | Health Care Utilization of Radiographs for Back Pain Over 10 Weeks | Use of radiographs for low back pain | All participants included in analyses based on Phase I treatment assignment with multiple imputation for missing data. | Posted | Count of Participants | Participants | baseline, 10 weeks |
|
|
|
|
| 0 |
| 374 |
| 9 |
| 374 |
| 0 |
| 374 |
| EG001 | Phase I CBT Treatment | This arm includes participants assigned to CBT for their Phase I treatment Cognitive Behavioral Therapy: Evidence-based cognitive behavioral therapy provided in 8 individual sessions focused on key components of CBT; 1) identifying and monitoring maladaptive cognitions, 2) developing coping strategies (e.g., distraction, relaxation, etc.), 3) setting and working towards behavioral goals, especially focused on physical activity, and 4) focusing on self-management skills and home instruction | 0 | 375 | 12 | 375 | 0 | 375 |
| EG002 | Phase I Non-Responders Re-Randomized to CBT | Includes all Non-Responders in Phase I who were re-randomized to CBT in Phase II Cognitive Behavioral Therapy: Evidence-based cognitive behavioral therapy provided in 8 individual sessions focused on key components of CBT; 1) identifying and monitoring maladaptive cognitions, 2) developing coping strategies (e.g., distraction, relaxation, etc.), 3) setting and working towards behavioral goals, especially focused on physical activity, and 4) focusing on self-management skills and home instruction Phase I Treatment: Includes all participants receiving any Phase I intervention | 0 | 103 | 2 | 103 | 0 | 103 |
| EG003 | Phase I Non-Responders Re-Randomized to PT | Includes all Non-Responders in Phase I who were re-randomized to PT in Phase II Physical Therapy: Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy. Phase I Treatment: Includes all participants receiving any Phase I intervention | 0 | 110 | 3 | 110 | 0 | 110 |
| EG004 | Phase I Non-Responders Re-Randomized to Mindfulness | Phase I Treatment: Includes all participants receiving any Phase I intervention who were re-randomized to Mindfulness. Mindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices. Phase I Treatment: Includes all participants receiving any Phase I intervention | 0 | 197 | 11 | 197 | 0 | 197 |
|
| COVID Hospitalization | Infections and infestations | Non-systematic Assessment |
|
| Musculoskeletal Injury or Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Injury to musculoskeletal system other than back surgery |
|
| Hopsitalization following accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hospitalized for abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hospitalized for Chest Pain | Cardiac disorders | Non-systematic Assessment |
|
| Hopsitalized for Osteomyelitis of humerus | Infections and infestations | Non-systematic Assessment |
|
| Appendectomy | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hopsitalized with DVT | Vascular disorders | Non-systematic Assessment |
|
| Hopsitalized for rectal bleeding | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004191 |
| Behavioral Disciplines and Activities |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Completed College Degree |
|
| 30 days - 1 year |
|
| > 1 year |
|
| 6-10 years ago |
|
| >10 years ago |
|
| Missing or Other |
|