Chronic Low-back Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDigital 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.
OTHERConventional 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.
Sponsors
Emory University
Sword Health, SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subjects aged between 18 and 80 years of age at enrolment * Reporting intermittent or persistent low back pain for at least 12 weeks, and/or present at least 50% of the time in the past 6 months * Ability to understand complex motor tasks
Exclusion criteria
* Known pregnancy * Submitted to spinal surgery less than 3 months ago * Symptoms and/or signs indicative of possible infectious disorder * Known disorder with indication for spine surgery (i.e., tumor, cauda equina syndrome) * Cancer diagnosis or undergoing treatment for cancer * Cardiac, respiratory or other known disorder incompatible with at least 20 minutes of light to moderate physical activity * Concomitant neurological disorder (e.g. Stroke, multiple sclerosis, Parkinson's disease) * Dementia or psychiatric disorders precluding patient from complying with a home-based exercise program * Illiteracy and/or serious visual or auditory impairment interfering with communication or compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index Score (ODI) | Baseline and 8 weeks after initiation of rehabilitation program | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Work Productivity and Activity Impairment (WPAI) Overall | Baseline and 8 weeks after initiation of rehabilitation program | 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%. |
| Interest in Undergoing Surgery | Baseline and 8 weeks after initiation of rehabilitation program | 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. |
| Medication Consumption | Baseline and 8 weeks after initiation of rehabilitation program | 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. |
| Fear Avoidance Beliefs - Physical Activity (FABQ-PA) | Baseline and 8 weeks after initiation of rehabilitation program | 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. |
| Anxiety | Baseline and 8 weeks after initiation of rehabilitation program | Change in the General Anxiety Disorder-7 scale score. Minimum score zero; maximum score 21. Lower scores indicate less severe anxiety. |
| Patient Satisfaction With Intervention | 8 weeks after initiation of rehabilitation program. | 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. |
| Physical Activity Levels | Baseline and 8 weeks after initiation of rehabilitation program | 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. |
| Depression | Baseline and 8 weeks after initiation of rehabilitation program | Change in the Patient Health Questionnaire 9 - 7 scale score. Minimum score zero; maximum score 27. Lower scores indicate less severe depression. |
| Pain Level | Baseline and 8 weeks after initiation of rehabilitation program | 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. |
| Treatment Intensity | Between baseline and 8 weeks. | Total number of minutes spent doing exercise sessions. |
| Work Productivity and Activity Impairment (WPAI) Work | Baseline and 8 weeks after initiation of rehabilitation program | 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% |
| Work Productivity and Activity Impairment (WPAI) Time | Baseline and 8 weeks after initiation of rehabilitation program | 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% |
| Work Productivity and Activity Impairment (WPAI) Activity | Baseline and 8 weeks after initiation of rehabilitation program | 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% |
| Dropout Rate | Program-end | Rate of patients who dropout from the program |
| Total Sessions | 8 weeks | Number of sessions performed at program-end |
| Frequency of Sessions Per Week | 8-weeks | Number of sessions performed per week in the 8-week rehabilitation program |
| Retention Rate | Between baseline and 8 weeks. | Number of participants that complete the 8 week program. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 70 |
| 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. | 70 |
| Total | 140 |
Baseline characteristics
| Characteristic | Digital Rehabilitation | Total | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|---|
| Age, Continuous | 50.50 years | 52.00 years | 54.50 years |
| Age, Customized <25 | 1 Participants | 5 Participants | 4 Participants |
| Age, Customized 25-40 | 21 Participants | 31 Participants | 10 Participants |
| Age, Customized 41-60 | 30 Participants | 61 Participants | 31 Participants |
| Age, Customized >60 | 18 Participants | 43 Participants | 25 Participants |
| Body Mass Index, categories Morbidly obese (>40) | 5 Participants | 11 Participants | 6 Participants |
| Body Mass Index, categories Normal (18.5-25) | 21 Participants | 42 Participants | 21 Participants |
| Body Mass Index, categories Obese (>30-40) | 23 Participants | 44 Participants | 21 Participants |
| Body Mass Index, categories Overweight (>25-30) | 21 Participants | 43 Participants | 22 Participants |
| Body Mass Index, continuous | 28.26 Kg/m2 | 28.3 Kg/m2 | 28.30 Kg/m2 |
| Comorbidities - Cardiac Conditions | 5 Participants | 7 Participants | 2 Participants |
| Comorbidities - High Blood Pressure | 23 Participants | 47 Participants | 24 Participants |
| Comorbidities - High Blood Sugar or Diabetes | 8 Participants | 16 Participants | 8 Participants |
| Comorbidities - None | 38 Participants | 75 Participants | 37 Participants |
| Comorbidities - Respiratory Conditions | 10 Participants | 20 Participants | 10 Participants |
| Education level Did not attend school | 0 Participants | 1 Participants | 1 Participants |
| Education level Four-year college degree or bachelor's degree | 17 Participants | 31 Participants | 14 Participants |
| Education level High school graduate or GED | 7 Participants | 12 Participants | 5 Participants |
| Education level Postgraduate or professional degree (including master's, doctorate, medical or law degree) | 23 Participants | 45 Participants | 22 Participants |
| Education level Prefer not to answer | 0 Participants | 1 Participants | 1 Participants |
| Education level Some colleges (some community colleges, associate degree) | 17 Participants | 36 Participants | 19 Participants |
| Education level Some high school | 2 Participants | 4 Participants | 2 Participants |
| Education level Some postgraduate or professional schooling, no postgraduate degree | 4 Participants | 10 Participants | 6 Participants |
| Employment status Employed (part-time or fulltime) | 48 Participants | 94 Participants | 46 Participants |
| Employment status Not employed and not seeking work | 14 Participants | 32 Participants | 18 Participants |
| Employment status Prefer not to answer | 1 Participants | 3 Participants | 2 Participants |
| Employment status Unemployed (seeking opportunities) | 7 Participants | 11 Participants | 4 Participants |
| Exercise levels >2.5 h | 22 Participants | 41 Participants | 19 Participants |
| Exercise levels Between 1-2.5 h | 18 Participants | 42 Participants | 24 Participants |
| Exercise levels Less than 1 h | 20 Participants | 33 Participants | 13 Participants |
| Exercise levels None | 10 Participants | 24 Participants | 14 Participants |
| Laterality of leg pain Both | 7 Participants | 19 Participants | 12 Participants |
| Laterality of leg pain Left | 14 Participants | 27 Participants | 13 Participants |
| Laterality of leg pain Missing | 36 Participants | 65 Participants | 29 Participants |
| Laterality of leg pain Right | 13 Participants | 29 Participants | 16 Participants |
| Low back-related leg pain | 34 Participants | 75 Participants | 41 Participants |
| Lumbar radicular pain | 21 Participants | 44 Participants | 23 Participants |
| Previous or scheduled low back surgery | 9 Participants | 15 Participants | 6 Participants |
| Previous physiotherapy | 38 Participants | 75 Participants | 37 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 11 Participants | 17 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 27 Participants | 61 Participants | 34 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Multi-racial or biracial | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Native American or Alaskan Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Prefer not to answer | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized White or Caucasian | 28 Participants | 51 Participants | 23 Participants |
| Sex: Female, Male Female | 46 Participants | 95 Participants | 49 Participants |
| Sex: Female, Male Male | 24 Participants | 45 Participants | 21 Participants |
| Smoking status | 1 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 57 |
| other Total, other adverse events | 11 / 63 | 6 / 57 |
| serious Total, serious adverse events | 0 / 63 | 0 / 57 |
Outcome results
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.
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Digital Rehabilitation | Oswestry Disability Index Score (ODI) | Baseline | 24.84 units on a scale |
| Digital Rehabilitation | Oswestry Disability Index Score (ODI) | 8-weeks | 17.94 units on a scale |
| Digital Rehabilitation | Oswestry Disability Index Score (ODI) | Change baseline-8 weeks | -6.90 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Oswestry Disability Index Score (ODI) | Baseline | 25.34 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Oswestry Disability Index Score (ODI) | 8-weeks | 18.99 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Oswestry Disability Index Score (ODI) | Change baseline-8 weeks | -6.35 units on a scale |
p-value: 0.41295% CI: [-2.42, 5.81]Quantile mixed-effects model
p-value: 0.84995% CI: [0.42, 2.05]Regression, Logistic
Secondary
Anxiety
Change in the General Anxiety Disorder-7 scale score. Minimum score zero; maximum score 21. Lower scores indicate less severe anxiety.
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Digital Rehabilitation | Anxiety | 8-weeks | 2.51 units on a scale |
| Digital Rehabilitation | Anxiety | Baseline | 3.79 units on a scale |
| Digital Rehabilitation | Anxiety | Change baseline-8 weeks | -1.28 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Anxiety | Baseline | 4.22 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Anxiety | 8-weeks | 2.51 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Anxiety | Change baseline-8 weeks | -1.70 units on a scale |
p-value: 0.3695% CI: [-0.59, 1.59]Quantile mixed-effects model
Secondary
Depression
Change in the Patient Health Questionnaire 9 - 7 scale score. Minimum score zero; maximum score 27. Lower scores indicate less severe depression.
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Digital Rehabilitation | Depression | 8-weeks | 3.22 units on a scale |
| Digital Rehabilitation | Depression | Change baseline-8-weeks | -0.87 units on a scale |
| Digital Rehabilitation | Depression | Baseline | 4.09 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Depression | 8-weeks | 2.48 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Depression | Change baseline-8-weeks | -2.19 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Depression | Baseline | 4.67 units on a scale |
p-value: 0.09595% CI: [-2.2, 2.46]Quantile mixed-effects model
Secondary
Dropout Rate
Rate of patients who dropout from the program
Time frame: Program-end
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Digital Rehabilitation | Dropout Rate | 11 Participants |
| Conventional Rehabilitation at an Outpatient Clinic | Dropout Rate | 24 Participants |
p-value: 0.019Chi-squared
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.
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Digital Rehabilitation | Fear Avoidance Beliefs - Physical Activity (FABQ-PA) | Baseline | 14.41 units on a scale |
| Digital Rehabilitation | Fear Avoidance Beliefs - Physical Activity (FABQ-PA) | 8-weeks | 12.48 units on a scale |
| Digital Rehabilitation | Fear Avoidance Beliefs - Physical Activity (FABQ-PA) | Change baseline-8 weeks | -1.92 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Fear Avoidance Beliefs - Physical Activity (FABQ-PA) | Baseline | 13.99 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Fear Avoidance Beliefs - Physical Activity (FABQ-PA) | 8-weeks | 12.48 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Fear Avoidance Beliefs - Physical Activity (FABQ-PA) | Change baseline-8 weeks | -1.50 units on a scale |
p-value: 0.87195% CI: [-2.1, 1.78]Quantile mixed-effects model
Secondary
Frequency of Sessions Per Week
Number of sessions performed per week in the 8-week rehabilitation program
Time frame: 8-weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Rehabilitation | Frequency of Sessions Per Week | 2.79 sessions per week | Standard Deviation 1.18 |
| Conventional Rehabilitation at an Outpatient Clinic | Frequency of Sessions Per Week | 1.55 sessions per week | Standard Deviation 0.62 |
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.
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Digital Rehabilitation | Interest in Undergoing Surgery | Baseline | 6.43 units on a scale |
| Digital Rehabilitation | Interest in Undergoing Surgery | 8-weeks | 0.06 units on a scale |
| Digital Rehabilitation | Interest in Undergoing Surgery | Change baseline-8 weeks | -6.37 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Interest in Undergoing Surgery | Baseline | 9.76 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Interest in Undergoing Surgery | 8-weeks | 0.06 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Interest in Undergoing Surgery | Change baseline-8 weeks | -9.69 units on a scale |
p-value: 0.78895% CI: [-3.11, 5.9]Quantile mixed-effects model
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.
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Digital Rehabilitation | Medication Consumption | 9 Participants |
| Conventional Rehabilitation at an Outpatient Clinic | Medication Consumption | 7 Participants |
p-value: 0.08195% CI: [0, 1.23]Regression, Logistic
p-value: 0.98595% CI: [0, 1.71]Regression, Logistic
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.
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Digital Rehabilitation | Pain Level | Baseline | 5.40 units on a scale |
| Digital Rehabilitation | Pain Level | 8-weeks | 3.59 units on a scale |
| Digital Rehabilitation | Pain Level | Change baseline-8 weeks | -1.81 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Pain Level | Baseline | 5.49 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Pain Level | 8-weeks | 3.38 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Pain Level | Change baseline-8 weeks | -2.11 units on a scale |
p-value: 0.66695% CI: [-0.71, 1.1]Quantile mixed-effects model
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.
Time frame: 8 weeks after initiation of rehabilitation program.
Population: This analysis includes only participants who completed the allocated digital or conventional interventions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Rehabilitation | Patient Satisfaction With Intervention | 8.4 units on a scale | Standard Deviation 2 |
| Conventional Rehabilitation at an Outpatient Clinic | Patient Satisfaction With Intervention | 8.4 units on a scale | Standard Deviation 2.6 |
p-value: 0.837t-test, 2 sided
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.
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Digital Rehabilitation | Physical Activity Levels | Baseline | High | 17 Participants |
| Digital Rehabilitation | Physical Activity Levels | Baseline | Moderate | 19 Participants |
| Digital Rehabilitation | Physical Activity Levels | Baseline | Low | 21 Participants |
| Digital Rehabilitation | Physical Activity Levels | 8-weeks | High | 23 Participants |
| Digital Rehabilitation | Physical Activity Levels | 8-weeks | Moderate | 20 Participants |
| Digital Rehabilitation | Physical Activity Levels | 8-weeks | Low | 14 Participants |
| Conventional Rehabilitation at an Outpatient Clinic | Physical Activity Levels | 8-weeks | Moderate | 15 Participants |
| Conventional Rehabilitation at an Outpatient Clinic | Physical Activity Levels | Baseline | High | 14 Participants |
| Conventional Rehabilitation at an Outpatient Clinic | Physical Activity Levels | 8-weeks | High | 17 Participants |
| Conventional Rehabilitation at an Outpatient Clinic | Physical Activity Levels | Baseline | Moderate | 16 Participants |
| Conventional Rehabilitation at an Outpatient Clinic | Physical Activity Levels | 8-weeks | Low | 13 Participants |
| Conventional Rehabilitation at an Outpatient Clinic | Physical Activity Levels | Baseline | Low | 15 Participants |
p-value: 0.886Ordinal Regression
Secondary
Retention Rate
Number of participants that complete the 8 week program.
Time frame: Between baseline and 8 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Digital Rehabilitation | Retention Rate | 57 Participants |
| Conventional Rehabilitation at an Outpatient Clinic | Retention Rate | 45 Participants |
Secondary
Total Sessions
Number of sessions performed at program-end
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Rehabilitation | Total Sessions | 22.32 sessions | Standard Deviation 9.46 |
| Conventional Rehabilitation at an Outpatient Clinic | Total Sessions | 12.42 sessions | Standard Deviation 4.95 |
Secondary
Treatment Intensity
Total number of minutes spent doing exercise sessions.
Time frame: Between baseline and 8 weeks.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Rehabilitation | Treatment Intensity | 451.78 minutes | Standard Deviation 227.36 |
| Conventional Rehabilitation at an Outpatient Clinic | Treatment Intensity | 385.98 minutes | Standard Deviation 145.36 |
p-value: 0.662Wilcoxon (Mann-Whitney)
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%
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Digital Rehabilitation | Work Productivity and Activity Impairment (WPAI) Activity | Baseline | 35.59 units on a scale |
| Digital Rehabilitation | Work Productivity and Activity Impairment (WPAI) Activity | 8-week | 22.66 units on a scale |
| Digital Rehabilitation | Work Productivity and Activity Impairment (WPAI) Activity | Change baseline-8 weeks | -12.93 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Work Productivity and Activity Impairment (WPAI) Activity | Baseline | 36.73 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Work Productivity and Activity Impairment (WPAI) Activity | 8-week | 23.45 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Work Productivity and Activity Impairment (WPAI) Activity | Change baseline-8 weeks | -13.28 units on a scale |
p-value: 0.6595% CI: [-6.22, 9.87]Quantile mixed-effects model
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%.
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Digital Rehabilitation | Work Productivity and Activity Impairment (WPAI) Overall | Baseline | 25.61 units on a scale |
| Digital Rehabilitation | Work Productivity and Activity Impairment (WPAI) Overall | 8-weeks | 16.87 units on a scale |
| Digital Rehabilitation | Work Productivity and Activity Impairment (WPAI) Overall | Change baseline-8 weeks | -8.74 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Work Productivity and Activity Impairment (WPAI) Overall | Baseline | 23.79 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Work Productivity and Activity Impairment (WPAI) Overall | 8-weeks | 17.67 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Work Productivity and Activity Impairment (WPAI) Overall | Change baseline-8 weeks | -6.12 units on a scale |
p-value: 0.12295% CI: [-14.87, 4.8]Quantile mixed-effects model
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%
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Digital Rehabilitation | Work Productivity and Activity Impairment (WPAI) Time | Baseline | 3.35 units on a scale |
| Digital Rehabilitation | Work Productivity and Activity Impairment (WPAI) Time | 8-weeks | 0.00 units on a scale |
| Digital Rehabilitation | Work Productivity and Activity Impairment (WPAI) Time | Change baseline-8 weeks | -3.36 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Work Productivity and Activity Impairment (WPAI) Time | Baseline | 2.63 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Work Productivity and Activity Impairment (WPAI) Time | 8-weeks | 0.00 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Work Productivity and Activity Impairment (WPAI) Time | Change baseline-8 weeks | -2.63 units on a scale |
p-value: 0.40895% CI: [-6.5, 2.69]Quantile mixed-effects model
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%
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Digital Rehabilitation | Work Productivity and Activity Impairment (WPAI) Work | Baseline | 23.52 units on a scale |
| Digital Rehabilitation | Work Productivity and Activity Impairment (WPAI) Work | 8-weeks | 15.33 units on a scale |
| Digital Rehabilitation | Work Productivity and Activity Impairment (WPAI) Work | Change baseline-8 weeks | -8.19 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Work Productivity and Activity Impairment (WPAI) Work | Baseline | 22.51 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Work Productivity and Activity Impairment (WPAI) Work | 8-weeks | 16.29 units on a scale |
| Conventional Rehabilitation at an Outpatient Clinic | Work Productivity and Activity Impairment (WPAI) Work | Change baseline-8 weeks | -6.22 units on a scale |
p-value: 0.24695% CI: [-12.69, 3.33]Quantile mixed-effects model