Effectiveness and Cost-Effectiveness of a Tele-Rehabilitation Program in the Treatment of Chronic Musculoskeletal Pain

Study Overview
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Brief Summary
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The aim of this clinical trial is to develop and test the effectiveness and cost-effectiveness of an internet-based self-management program based on pain education and exercise for people with chronic musculoskeletal pain.

Detailed Description
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Chronic pain is a major burden on the individual and society. It is estimated that about one third of the adult population worldwide suffer from chronic pain, with higher prevalence rates reported for low-income countries. Internet-based self-management programs have grown with the development of new technologies and have been extensively used for delivering healthcare in many areas. However, there is still little research on the development and testing of remotely-delivered programs for the management of chronic musculoskeletal pain, especially in low and mid-income countries. The aim of this clinical trial is to develop and test the effectiveness and cost-effectiveness of an internet-based self-management program based on pain education and exercise for people with chronic musculoskeletal pain.

Official Title
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Effectiveness and Cost-Effectiveness of a Tele-Rehabilitation Program in the Treatment of Chronic Musculoskeletal Pain

Conditions
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Chronic Pain

Intervention / Treatment
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* Other: Internet-Based Pain Education and Exercise
* Other: Online Booklet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 and 60 years Seeking treatment for any chronic musculoskeletal pain of at least 3 points in a 0 to 10 Pain Numerical Rating Scale Able to read and understand Portuguese With internet access. Chronic Pain will be defined as pain lasting more than 12 weeks. Exclusion Criteria: Present neurological symptoms (nerve root compromise, or sensation deficits) Present serious spinal pathologies (e.g., fracture, tumor, inflammatory, autoimmune, and infectious diseases) Present serious cardiovascular and metabolic diseases (e.g., coronary heart disease, cardiac insufficiency, decompensated diabetes) Recent orthopaedic surgery (over the last 12 months) Scheduled to undergo surgery in the next 6 months, or pregnancy If have any contraindication to exercise We will perform a pre-screening for physical activity participation at baseline using the Physical Activity Readiness Questionnaire (PAR-Q) Portuguese version to rule out any contraindication to participate in physical activity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: This is a controlled clinical trial, with the Intervention group performing the 8-week follow-up and access to 8 pain education videos and 8 exercise videos prescribed for patients with chronic pain, and the control group receiving information on chronic pain for one booklet. Randomized through site programming, so that the subject enters his / her login and password and is directed to one of the study groups, with blind evaluator without access to randomization information throughout the course of the study and follow-up of the outcome measures for 3 , 6 and 12 months after randomization.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-Based Pain Education and Exercise<br>Patients allocated to the intervention group will receive a login and password for individual access to the website designed for the study. The content of this intervention will include videos and animations based on pain education, physical activity promotion and general exercises. The pain education component will be based on the E-pain intervention developed by Reis et al (2017), which includes nine main features: (1) acceptance, (2 and 3) education about pain, (4) sleep hygiene, (5) recognizing stress and negative emotions, (6) increasing positive coping in lifestyle, (7) exercises, (8) communication and (9) relapse prevention. The exercise component will include general exercises aiming to improve strength, flexibility, control and coordination. Patients in this group will also receive weekly text messages and a health coaching over the telephone. The text messages will include information on the benefits of exercises, motivation, and positive messages about dealing with pain. | Other: Internet-Based Pain Education and Exercise<br>* Telerehabilitation is defined as providing techniques for therapeutic rehabilitation remotely or off-site using telecommunication technologies. Thus, our intervention will be based on the use of a website created and registered especially for the study that will have the shooting of 1 video of pain education and 1 video of exercises for the subjects of the study, totaling 8 videos of pain education and 8 exercise videos. We will provide complimentary materials along with the triggered videos and a booklet of chronic pain information. We will also make weekly calls for a health coaching service and the sending of smartphone messages for the motivation and accountability of the subjects.<br>* Other names: Telerehabilitation;|
| Active Comparator: Online Booklet<br>The patients allocated to the control group will have access to an online booklet containing general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises. They will also receive one phone call at week 4 and text messages once a week during the study period. | Other: Online Booklet<br>* An online booklet containing information about chronic pain and suggestions for lifestyle modifications and behavior will be delivered, as well as an incentive to perform physical exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity at post-treatment follow-up | The primary outcome will be pain intensity measured using the Pain Numerical Rating Scale, a numerical scale of 11 domains, where 0 indicates no pain and 10 indicates maximum pain intensity. | Post-treatment follow-up (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity at 6 months and 12 months follow-up | TMeasured using the Pain Numerical Rating Scale, a numerical scale of 11 domains, where 0 indicates no pain and 10 indicates maximum pain intensity. | 6 months and 12 months follow-up | 
| Function | Measured with the Patient Specific Functional Scale, a self-reported scale specific for the measurement of functionality in musculoskeletal injuries, where the patient classifies his activities from 0 to 10, being 0 the inability to perform that function and 10 the total capacity to perform the function; | The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject. | 
| Health-Related Quality of Life | Measured with the SF-12, a self-reported questionnaire with 12 questions and classification of 8 different dimensions related to quality of life. Higher scores define better quality of life; | The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject. | 
| Kinesiophobia | Measured with the Tampa Scale of Kinesiophobia, a self-reported questionnaire with 17 questions, where the patient ranks totally disagree statements equivalent to one point, partially disagree, two points, partially agree, three points and totally agree, four points . Higher scores at the end of the questionnaire identify worse results in kinesiophobia outcome; | The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject. | 
| Global Perceived Effect | Measured with the Global Perceived Effect Scale, a self-reported scale, with scores of -5 to 5, where the progression of the patient's condition will be classified from a certain point in time. Scores of -5 indicate a lot of worsening and scores of 5 indicate a lot of improvement. | The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject. | 
| Anxiety and Depression | Measured by the Hospital Anxiety and Depression Scale, a self-reported scale with 14 questions, 7 for depression and 7 for anxiety. Each question has a rating ranging from 0 to 3 according to the patient's response. Scores near 21 indicate the worst results. | The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject. | 
| Pain Catastrophisation | Measured with the Pain Catastrophising Scale, a self-reported scale with 13 statements, where the patient ranks the affirmations between 0 being minimal to 4 very intense. The calculation of the final score is based on 3 subdomains of the scale and scores closer to 52 indicate worse results. | The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject. | 
| Pain-related Attitudes and Beliefs | Measured with Orebro Musculoskeletal Pain Questionnaire, a self-reported questionnaire with questions related to musculoskeletal pain classified from 0 to 10 and its score calculated later according to these answers and using an own algorithm of the questionnaire. | The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject. | 
| Self-efficacy | Measured with Pain Self-Efficacy Questionnaire, a questionnaire with 22 questions classified in three domains, with a score of each domain ranging from 10 to 100. A total score close to 300 indicates a greater sense of self-efficacy. | The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject. | 
| Adverse Effects | Measured by recording the number of adverse events during the intervention period. | The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain, Telerehabilitation, Telemedicine, Physical Therapy