Digital Care Program for Chronic Low Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Digital Care Program for Chronic Low Back Pain Versus Conventional Physical Therapy: a Prospective, Randomized Controlled Study

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Device: Digital program
* Other: Conventional PT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Rehabilitation<br>Home-based rehabilitation with a digital biofeedback system | Device: Digital program<br>* 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.<br>|
| Active Comparator: Conventional rehabilitation at an outpatient clinic<br> | Other: Conventional PT<br>* Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face PT 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 PT sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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, 4 and 8 weeks after initiation of rehabilitation program | 

Secondary Outcome Measures

| Outcome Measure | 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, 4 weeks and 8 weeks after initiation of rehabilitation program | 
| Work productivity and activity impairment (WPAI) | Change in WPAI 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, 4 weeks 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, 4 weeks 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, 4 weeks and 8 weeks after initiation of rehabilitation program | 
| Fear avoidance beliefs (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, 4 weeks 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, 4 weeks and 8 weeks after initiation of rehabilitation program | 
| Adherence | Measured through the number of attended versus scheduled sessions throughout the 8 week program. | Between enrollment and 8 weeks | 
| 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: inactive, minimally active and active, with higher scores translating into higher activity levels. | Baseline, 4 weeks and 8 weeks after initiation of rehabilitation program | 
| Depression | Change in the Patient Health Questionnaire 9. Minimum score zero; maximum score 27. Lower scores indicate less severe depression. | Baseline, 4 weeks 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. |