Exercise-based Telerehabilitation Program for Police Officers and Firefighters With Chronic Non-specific Low Back 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 of a smartphone app-based self-management program based on exercise and pain education for police officers and firefighters with chronic low back pain.

Detailed Description
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Low back pain is the leading cause of year lived with disability worldwide. Workers exposed to physically demanding activities and inappropriate postures, such as those performed by police officers and firefighters, are highly affected by chronic low back pain. Smartphone app-based self-managed interventions have been shown to be an alternative for chronic non-specific low back pain treatment. However, there is still little research on the development and testing of remotely-delivered programs for the management of chronic low back pain, especially in police and fire professionals. The aim of this clinical trial is to develop and test the effectiveness of a smartphone app-based self-management program based on exercise and pain education for police officers and firefighters with chronic low back pain.

Official Title
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Effectiveness of an Exercise-based Telerehabilitation Program for Police Officers and Firefighters With Chronic Non-specific Low Back Pain: a Randomized Clinical Trial

Conditions
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Chronic Low-back Pain, Telerehabilitation

Intervention / Treatment
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* Other: App-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 Chronic low back pain (defined as pain lasting more than 12 weeks) Chronic low back pain of at least 3 points in a 0 to 10 Pain Numerical Rating Scale Own a smartphone with internet access and email account Police officer (federal, federal highway, civil or military) or military firefighter working in the State of Rio Grande do Sul Exclusion Criteria: Present neurological symptoms (nerve root compromise, or sensation deficits) Present serious spinal diseases (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 spine surgery (over the last 12 months) or scheduled to undergo surgery in the next six months, or pregnancy History of physical therapy treatment for low back pain or physical exercise (strength training for core muscles, Pilates, yoga) current or within the last 3 months Retired 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: The Intervention group will perform the 8-week treatment with access to 8 pain education messages (1 message/week) and 8 weeks of an exercise program prescribed for people with chronic low back pain, and the control group will receive information on chronic low back pain for one booklet and access to 8 pain education messages (1 message/week). Randomized through software, so that the subject enters his/her login and password and is directed to one of the study groups, with a blind evaluator without access to randomization information throughout the study and follow-up of the outcome measures for 4 months after randomization.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App-Based Pain Education and Exercise<br>Patients allocated to the experimental group will receive a login and password for individual access to the smartphone app designed for the study. The app's content for this group will include three components: 1) a physical exercise program of 8 weeks; 2) weekly messages; and 3) an online booklet. The exercise component will include 8 weeks of training, with two sessions per week of core strengthening exercises. The app will provide illustrations, with animated images (GIFs), descriptions and audios of how to perform each exercise. The message component will provide eight messages (one per week), which will have their contents taken from the online booklet. Messages will include information about the benefits of exercise, motivation, and positive messages about coping with pain. The online booklet will contain general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises. | Other: App-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 smartphone application created especially for the study that will contain a program of progressive physical exercises with images and descriptions, educational messages and an online booklet for the study subjects, totaling 8 weeks of training and pain education.<br>* Other names: Telerehabilitation;|
| Active Comparator: Online Booklet<br>Patients allocated to the control group will receive a login and password for individual access to the smartphone app designed for the study. The app's content for this group will include two components: 1) an online booklet; and 2) weekly messages. The online booklet will contain general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises. The message component will provide eight messages (one per week), which will have their contents taken from the online booklet. Messages will include information about the benefits of exercise, motivation, and positive messages about coping with pain. | Other: Online booklet<br>* An online booklet containing information about chronic low back pain and weekly messages about low back pain causes, 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) | 
| Disability at post-treatment follow-up | The primary outcome will be disability measured using the Roland Morris Disability Questionnaire, a 24-item questionnaire that assesses normal activities of daily living, where a higher score indicating a higher level of disability. | Post-treatment follow-up (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity at 4 months follow-up | Measured using the Pain Numerical Rating Scale, a numerical scale of 11 domains, where 0 indicates no pain and 10 indicates maximum pain intensity. | 4 months follow-up | 
| Disability at 4 months follow-up | Measured using the Roland Morris Disability Questionnaire, a 24-item questionnaire that assesses normal activities of daily living, where a higher score indicating a higher level of disability. | 4 months follow-up | 
| Health-Related Quality of Life | Measured with the WHOQOL-Pain, a self-reported questionnaire with 16 questions and classification of 4 facets related to the experience of chronic physical pain. | The outcome will be evaluated after the treatment period (8 weeks) and after 4 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) and after 4 months of randomization of each subject. | 
| Depression, Anxiety and Stress | Measured by the Depression Anxiety Stress Scale, a self-reported scale with 21 questions, 7 for depression, 7 for anxiety and 7 for stress. Each question ranges 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) and after 4 months of randomization of each subject. | 
| Sleep quality | Measured by the Pittsburgh Sleep Quality Index, a self-reported scale with 19 questions, that assess seven components of sleep. Each question ranges from 0 to 3 according to the patient's response. Scores near 21 indicate worse sleep quality. | The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject. | 
| Work ability | Measured by a single-item question: Are you working at a physically less demanding job now because of your back and/or leg pain? | The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject. | 
| Isometric muscular endurance of the trunk extensor | Measured by modified Biering-Sorensen test. | The outcome will be evaluated after the treatment period (8 weeks). | 
| Isometric muscular endurance of the trunk flexors | Measured by a test that consists of remaining in isometry as long as possible. | The outcome will be evaluated after the treatment period (8 weeks). | 
| Maximum isometric strength of the trunk extensor and flexor muscles | Measured by a load cell. | The outcome will be evaluated after the treatment period (8 weeks). | 
| Muscular activation of flexor and extensor muscles | Measured using the surface electromyography technique. The neuromuscular activation of flexor (rectus abdominis) and extensor (spinal erector) muscles will be measured. | The outcome will be evaluated after the treatment period (8 weeks). | 
| 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) and after 4 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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low back pain, Telerehabilitation