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| Name | Class |
|---|---|
| Emory University | OTHER |
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New ways of delivering care are much needed to address chronic low back pain. Crucially, these need to: a) address the three pillars of care to achieve good and sustained clinical outcomes; b) overcome barriers to access; c) ensure patients are engaged throughout the programs; d) be scalable and cost-efficient. SWORD Health has developed a digital care program to address these needs. This study aims to assess the clinical outcomes of this rehabilitation program versus conventional physical therapy.
Low back pain (LBP) has for long been the world's leading cause of years leaved with disability,1 and, considering that the overall life expectancy is rising, this pandemic only tends to get worse. Nearly everyone is affected by LBP at some moment in life (70-80% of lifetime prevalence). As a consequence, LBP is also presented as a leading cause of work absenteeism worldwide. Thus, although the estimate costs of LBP may be difficult to compare between different countries, its overwhelming socio-economic impact in modern society is evident.
In the absence of an effective treatment, LBP can become chronic, causing a huge impact in patients' daily life, and ultimately promoting a high consumption of healthcare resources. In the US alone, health expenditures for adults with spinal problems were estimated at $6000 per person, representing a total cost of $102 billion each year.
The dim picture described above highlights the urgent need for effective interventions that minimize disability, improve quality of life and decrease productivity losses.
Current guidelines on CLBP management recommend patient education, exercise, physical therapy (PT), and behavioural therapy as the mainstay treatments for this condition.
Despite some discrepancy in the type of exercise program (e.g. aquatic exercises, stretching, back schools, McKenzie exercise approach, yoga, tai-chi) and mode of delivery (e.g., individually designed programs, supervised home exercise, and group exercise), exercise therapy is recommended nearly transversally, with most studies concluding that exercise intervention programs should include a combination of muscular strength, flexibility and aerobic fitness exercises. Moreover, home exercises with a regular therapist follow-up has proven highly effective.
This is not, however, how LBP is currently managed. Appropriate patient education and structured behavioural training are rarely provided, and opioid prescription is also a common practice, despite known opioid-related morbidity and mortality rates. Because the prevalence of CLBP is continuously rising, and opioid misuse is an issue of great concern globally, identifying effective nonopioid alternatives for CLBP is of paramount importance.
Further compounding this problem, from the patients who are directed to PT, almost half give up after just 4 sessions, and only 30% complete their programs.
In this context, new ways of delivering care are much needed. Crucially, these need to: a) address the three pillars of care to achieve good and sustained clinical outcomes; b) overcome barriers to access; c) ensure patients are engaged throughout the programs; d) be scalable and cost-efficient.
This study aims to assess the clinical outcomes of a digital program for chronic low back pain versus conventional PT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Rehabilitation | Experimental | Home-based rehabilitation with a digital biofeedback system |
|
| Conventional rehabilitation at an outpatient clinic | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital program | Device | Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health. These patients will be referred to SWORD Health by the investigator who identified the candidate. SWORD Health will then assign a physical therapist to each patient. The physical therapist will contact the patient for onboarding and will manage the case. |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index Score (ODI) | The minimum value of the score is 0% and the maximum is 100%, with lower scores translating into lower disability. In this study, we will be assessing the change between baseline and 8 weeks in Oswestry Disability Index score. | Baseline and 8 weeks after initiation of rehabilitation program |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Level | Change in pain level Measured through the following question: "On a scale of 0 to 10, where 0 is no pain and 10 the worst pain imaginable, how would you rate your pain in the last 24 hours?" Minimum and maximum values of the scale are respectively 0 and 10, with lower values representing less pain. | Baseline and 8 weeks after initiation of rehabilitation program |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cui Di, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Orthopaedic and Spine Center (Atlanta, Ga) | Atlanta | Georgia | 30324 | United States |
The study protocol will be made available in PDF format. Aggregate study results, with anonymised individual participant data will be made available in Excel format
Upon study publication, for at least five years.
Study protocol will be made available in clinicaltrials.gov and the excel file with the aggregate results will be made available upon study publication, for at least 5 years.
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| ID | Title | Description |
|---|---|---|
| FG000 | Digital Rehabilitation | Home-based rehabilitation with a digital biofeedback system Digital program: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health. These patients will be referred to SWORD Health by the investigator who identified the candidate. SWORD Health will then assign a physical therapist to each patient. The physical therapist will contact the patient for onboarding and will manage the case. |
| FG001 | Conventional Rehabilitation at an Outpatient Clinic | Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program will follow the protocol outlined in Annex 3, which can however be adapted by the physical therapist to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Digital Rehabilitation | Home-based rehabilitation with a digital biofeedback system Digital program: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health. These patients will be referred to SWORD Health by the investigator who identified the candidate. SWORD Health will then assign a physical therapist to each patient. The physical therapist will contact the patient for onboarding and will manage the case. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Oswestry Disability Index Score (ODI) | The minimum value of the score is 0% and the maximum is 100%, with lower scores translating into lower disability. In this study, we will be assessing the change between baseline and 8 weeks in Oswestry Disability Index score. | Posted | Median | 95% Confidence Interval | units on a scale | Baseline and 8 weeks after initiation of rehabilitation program |
|
8 weeks
The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered.
Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).
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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 | Digital Rehabilitation | Home-based rehabilitation with a digital biofeedback system Digital program: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health. These patients will be referred to SWORD Health by the investigator who identified the candidate. SWORD Health will then assign a physical therapist to each patient. The physical therapist will contact the patient for onboarding and will manage the case. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Brain Bleeding | Vascular disorders | Non-systematic Assessment | Not related to Study Intervention. Severity: Severe. Action taken with study treatment: None. |
Lack of (i) blinding of patients, physical therapists, and investigators due to the intervention's nature; (ii) objective outcome measures (eg, muscle strength, range of motion); (iii) an externally blinded outcome adjudicator. The COVID-19 pandemic may have positively influenced compliance. Higher dropout in the conventional group highlights the need for strategies like additional contacts. Greater granularity in pharmacological data (type, dosage, frequency) is necessary.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fernando Dias Correia | Sword Health Inc | +1 (646) 379-6751 | fcorreia@swordhealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 26, 2020 | Dec 9, 2024 | Prot_SAP_ICF_000.pdf |
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Randomized controlled study
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Blinding of investigators and patients regarding allocation arm will not be possible, given the nature of the intervention. Analysis of study results will be performed by a statistician blinded to allocation groups.
|
| Conventional physical therapy | Other | Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program will follow the protocol outlined in Annex 3, which can however be adapted by the physical therapist to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions. |
|
| Work Productivity and Activity Impairment (WPAI) Overall | Change in WPAI overall scores. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, with a minimum of 0% and a maximum of 100%. | Baseline and 8 weeks after initiation of rehabilitation program |
| Interest in Undergoing Surgery | Change in surgery intent measured through the following question: "On a scale of 0 to 10, where 0 is not at all and 10 is extremely interested, how interested are you in undergoing back surgery in the next 12 months"? Minimum and maximum values of the scale are respectively 0 and 10, with lower values representing a lower interest. | Baseline and 8 weeks after initiation of rehabilitation program |
| Medication Consumption | Change in medication consumption, measured through the following questions: i. "Are you taking any medication for your low back pain?"; binary score ii. "If yes, are you taking opioids for your low back pain?"; binary score iii. "If yes, on how many days in a week, on average, are you taking medication for your low back pain" minimum 0; max 7 days, with 7 being worse. | Baseline and 8 weeks after initiation of rehabilitation program |
| Fear Avoidance Beliefs - Physical Activity (FABQ-PA) | Change in Fear avoidance beliefs-Physical Activity questionnaire - Physical Activity subscale. The questionnaire consists of 4 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 24 and a minimum score of 0. Lower scores mean lower fear avoidance. | Baseline and 8 weeks after initiation of rehabilitation program |
| Anxiety | Change in the General Anxiety Disorder-7 scale score. Minimum score zero; maximum score 21. Lower scores indicate less severe anxiety. | Baseline and 8 weeks after initiation of rehabilitation program |
| Patient Satisfaction With Intervention | Measured through the following question: "On a scale from 0 to 10, how likely would you recommend this program to a friend or colleague?". Minimum value is zero and maximum is 10. Higher scores translate higher satisfaction. | 8 weeks after initiation of rehabilitation program. |
| Physical Activity Levels | Change in the International Physical Activity Questionnaire- Short Form. The scale scores are calculated to provide a qualitative score: low, moderate and high with higher scores translating into higher activity levels. | Baseline and 8 weeks after initiation of rehabilitation program |
| Depression | Change in the Patient Health Questionnaire 9 - 7 scale score. Minimum score zero; maximum score 27. Lower scores indicate less severe depression. | Baseline and 8 weeks after initiation of rehabilitation program |
| Retention Rate | Number of participants that complete the 8 week program. | Between baseline and 8 weeks. |
| Treatment Intensity | Total number of minutes spent doing exercise sessions. | Between baseline and 8 weeks. |
| Work Productivity and Activity Impairment (WPAI) Work | Change in WPAI work scores. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, with a minimum of 0% and a maximum of 100% | Baseline and 8 weeks after initiation of rehabilitation program |
| Work Productivity and Activity Impairment (WPAI) Time | Change in WPAI time scores. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, with a minimum of 0% and a maximum of 100% | Baseline and 8 weeks after initiation of rehabilitation program |
| Work Productivity and Activity Impairment (WPAI) Activity | Change in WPAI Activity scores. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, with a minimum of 0% and a maximum of 100% | Baseline and 8 weeks after initiation of rehabilitation program |
| Dropout Rate | Rate of patients who dropout from the program | Program-end |
| Total Sessions | Number of sessions performed at program-end | 8 weeks |
| Frequency of Sessions Per Week | Number of sessions performed per week in the 8-week rehabilitation program | 8-weeks |
| BG001 | Conventional Rehabilitation at an Outpatient Clinic | Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program will follow the protocol outlined in Annex 3, which can however be adapted by the physical therapist to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education level | Count of Participants | Participants |
|
| Body Mass Index, categories | Count of Participants | Participants |
|
| Employment status | Count of Participants | Participants |
|
| Exercise levels | Count of Participants | Participants |
|
| Smoking status | Number of participants who reported being current smokers at baseline measured through the question "Do you smoke?". Participants were classified as smokers or non-smokers based on their responses. | Count of Participants | Participants |
|
| Low back-related leg pain | Count of Participants | Participants |
|
| Laterality of leg pain | Count of Participants | Participants |
|
| Lumbar radicular pain | Count of Participants | Participants |
|
| Previous physiotherapy | Count of Participants | Participants |
|
| Previous or scheduled low back surgery | Count of Participants | Participants |
|
| Body Mass Index, continuous | Median | Inter-Quartile Range | Kg/m2 |
|
| Comorbidities - High Blood Pressure | Count of Participants | Participants |
|
| Comorbidities - High Blood Sugar or Diabetes | Count of Participants | Participants |
|
| Comorbidities - Cardiac Conditions | Count of Participants | Participants |
|
| Comorbidities - Respiratory Conditions | Count of Participants | Participants |
|
| Comorbidities - None | Count of Participants | Participants |
|
| OG001 | Conventional Rehabilitation at an Outpatient Clinic | Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program will follow the protocol outlined in Annex 3, which can however be adapted by the physical therapist to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions. |
|
|
|
| Secondary | Pain Level | Change in pain level Measured through the following question: "On a scale of 0 to 10, where 0 is no pain and 10 the worst pain imaginable, how would you rate your pain in the last 24 hours?" Minimum and maximum values of the scale are respectively 0 and 10, with lower values representing less pain. | Posted | Median | 95% Confidence Interval | units on a scale | Baseline and 8 weeks after initiation of rehabilitation program |
|
|
|
|
| Secondary | Work Productivity and Activity Impairment (WPAI) Overall | Change in WPAI overall scores. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, with a minimum of 0% and a maximum of 100%. | This analysis includes only participants who completed the WPAI Overall questionnaire. Participants who did not respond to this questionnaire were excluded from the analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study. | Posted | Median | 95% Confidence Interval | units on a scale | Baseline and 8 weeks after initiation of rehabilitation program |
|
|
|
|
| Secondary | Interest in Undergoing Surgery | Change in surgery intent measured through the following question: "On a scale of 0 to 10, where 0 is not at all and 10 is extremely interested, how interested are you in undergoing back surgery in the next 12 months"? Minimum and maximum values of the scale are respectively 0 and 10, with lower values representing a lower interest. | Posted | Median | 95% Confidence Interval | units on a scale | Baseline and 8 weeks after initiation of rehabilitation program |
|
|
|
|
| Secondary | Medication Consumption | Change in medication consumption, measured through the following questions: i. "Are you taking any medication for your low back pain?"; binary score ii. "If yes, are you taking opioids for your low back pain?"; binary score iii. "If yes, on how many days in a week, on average, are you taking medication for your low back pain" minimum 0; max 7 days, with 7 being worse. | This analysis includes only participants who reported medication consumption at baseline. Participants who did not report medication use at baseline were excluded from this analysis. As a result, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study. | Posted | Count of Participants | Participants | Baseline and 8 weeks after initiation of rehabilitation program |
|
|
|
|
| Secondary | Fear Avoidance Beliefs - Physical Activity (FABQ-PA) | Change in Fear avoidance beliefs-Physical Activity questionnaire - Physical Activity subscale. The questionnaire consists of 4 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 24 and a minimum score of 0. Lower scores mean lower fear avoidance. | Posted | Median | 95% Confidence Interval | units on a scale | Baseline and 8 weeks after initiation of rehabilitation program |
|
|
|
|
| Secondary | Anxiety | Change in the General Anxiety Disorder-7 scale score. Minimum score zero; maximum score 21. Lower scores indicate less severe anxiety. | Posted | Median | 95% Confidence Interval | units on a scale | Baseline and 8 weeks after initiation of rehabilitation program |
|
|
|
|
| Secondary | Patient Satisfaction With Intervention | Measured through the following question: "On a scale from 0 to 10, how likely would you recommend this program to a friend or colleague?". Minimum value is zero and maximum is 10. Higher scores translate higher satisfaction. | This analysis includes only participants who completed the allocated digital or conventional interventions. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks after initiation of rehabilitation program. |
|
|
|
|
| Secondary | Physical Activity Levels | Change in the International Physical Activity Questionnaire- Short Form. The scale scores are calculated to provide a qualitative score: low, moderate and high with higher scores translating into higher activity levels. | Posted | Count of Participants | Participants | Baseline and 8 weeks after initiation of rehabilitation program |
|
|
|
|
| Secondary | Depression | Change in the Patient Health Questionnaire 9 - 7 scale score. Minimum score zero; maximum score 27. Lower scores indicate less severe depression. | Posted | Median | 95% Confidence Interval | units on a scale | Baseline and 8 weeks after initiation of rehabilitation program |
|
|
|
|
| Secondary | Retention Rate | Number of participants that complete the 8 week program. | Posted | Count of Participants | Participants | Between baseline and 8 weeks. |
|
|
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| Secondary | Treatment Intensity | Total number of minutes spent doing exercise sessions. | This analysis includes only participants who received the allocated intervention. Participants who did not receive the intervention were excluded from this analysis. Therefore, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study. | Posted | Mean | Standard Deviation | minutes | Between baseline and 8 weeks. |
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| Secondary | Work Productivity and Activity Impairment (WPAI) Work | Change in WPAI work scores. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, with a minimum of 0% and a maximum of 100% | This analysis includes only participants who completed the WPAI Work questionnaire. Participants who did not respond to this questionnaire were excluded from the analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study. | Posted | Median | 95% Confidence Interval | units on a scale | Baseline and 8 weeks after initiation of rehabilitation program |
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| Secondary | Work Productivity and Activity Impairment (WPAI) Time | Change in WPAI time scores. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, with a minimum of 0% and a maximum of 100% | This analysis includes only participants who completed the WPAI Time questionnaire. Participants who did not respond to this questionnaire were excluded from the analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study. | Posted | Median | 95% Confidence Interval | units on a scale | Baseline and 8 weeks after initiation of rehabilitation program |
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| Secondary | Work Productivity and Activity Impairment (WPAI) Activity | Change in WPAI Activity scores. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, with a minimum of 0% and a maximum of 100% | Posted | Median | 95% Confidence Interval | units on a scale | Baseline and 8 weeks after initiation of rehabilitation program |
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| Secondary | Dropout Rate | Rate of patients who dropout from the program | Posted | Count of Participants | Participants | Program-end |
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| Secondary | Total Sessions | Number of sessions performed at program-end | This analysis includes only participants who received the allocated intervention. Participants who did not receive the intervention were excluded from this analysis. Therefore, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study. | Posted | Mean | Standard Deviation | sessions | 8 weeks |
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| Secondary | Frequency of Sessions Per Week | Number of sessions performed per week in the 8-week rehabilitation program | This analysis includes only participants who received the allocated intervention. Participants who did not receive the intervention were excluded from this analysis. Therefore, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study. | Posted | Mean | Standard Deviation | sessions per week | 8-weeks |
|
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| 11 |
| 63 |
| EG001 | Conventional Rehabilitation at an Outpatient Clinic | Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program will follow the protocol outlined in Annex 3, which can however be adapted by the physical therapist to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions. | 0 | 57 | 0 | 57 | 6 | 57 |
|
| Spine Procedure | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Lumbar medial branch block. Unlikely related to Study Intervention. Severity: Moderate. Action taken with study treatment: Other. |
|
| Chest Pain | General disorders | Non-systematic Assessment | Development of Chest Pain with visit to emergency room. Not related to Study Intervention. Severity: Moderate. Action taken with study treatment: None. |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment | Not related or unlikely related to Study Intervention. Severity: Mild. Action taken with study treatment: None, Intervention discontinued, or Change of treatment program. |
|
| Knee Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unlikely related to Study Intervention. Severity: Moderate. Action taken with study treatment: None. |
|
| Covid-19 infection | Infections and infestations | Non-systematic Assessment | Not related to Study Intervention. Severity: Mild. Action taken with study treatment: Change of treatment program. |
|
| Low Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Worsening pain or injury after moving. Not related or unlikely related to Study Intervention. Severity: Mild or Moderate. Action taken with study treatment: None, Change of treatment program, or Other. |
|
| Arm Cyst | Infections and infestations | Non-systematic Assessment | Urgent care needed. Not related to Study Intervention. Severity: Mild. Action taken with study treatment: Other. |
|
| Foot Swelling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Not related to Study Intervention. Severity: Mild. Action taken with study treatment: Other. |
|
| Lumbar Spinal Injection Reaction | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Not related to Study Intervention. Severity: Moderate. Action taken with study treatment: Change of treatment program. |
|
| Ankle Sprain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Not related to Study Intervention. Severity: Mild. Action taken with study treatment: None. |
|
| Struck by Car | Social circumstances | Non-systematic Assessment | Not related to Study Intervention. Severity: Moderate. Action taken with study treatment: Change of treatment program. |
|
| Cold sickness | Infections and infestations | Non-systematic Assessment | Not related to Study Intervention. Severity: Mild. Action taken with study treatment: None. |
|
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| Change baseline-8 weeks |
|
| Change baseline-8 weeks |
|
| Change baseline-8 weeks |
|
| Regression, Logistic |
LR to assess the odds between groups for consuming opioids at 8 weeks using the CG as a reference. |
| 0.985 |
The threshold for statistical significance was set at 0.05. |
| Odds Ratio (OR) |
| 0.26 |
| 2-Sided |
| 95 |
| 0.00 |
| 1.71 |
| Equivalence |
| Change baseline-8 weeks |
|
| Change baseline-8 weeks |
|
| Low |
|
| 8-weeks |
|
| Change baseline-8-weeks |
|
| Change baseline-8 weeks |
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| Change baseline-8 weeks |
|
| Change baseline-8 weeks |
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