Exercise-based Telerehabilitation Program for Police Officers and Firefighters With Chronic Non-specific Low Back Pain

Not Applicable

Completed

• Conditions: Chronic Low-back Pain; Telerehabilitation
• Interventions: Other: App-Based Pain Education and Exercise; Other: Online booklet

• Registration Number: NCT05481996
• Lead Sponsor: Federal University of Pelotas

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-08-01
• Study Start: 2022-10-10
• Primary Completion: 2023-06-20
• Study Completion: 2023-08-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
App-Based Pain Education and Exercise	App-Based Pain Education and Exercise	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.
Online Booklet	Online booklet	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.

Primary Outcome Measures

Name	Time	Method
Pain Intensity at post-treatment follow-up	Post-treatment follow-up (8 weeks)	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.
Disability at post-treatment follow-up	Post-treatment follow-up (8 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Disability at 4 months follow-up	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.
Health-Related Quality of Life	The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.	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.
Depression, Anxiety and Stress	The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.	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.
Sleep quality	The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.	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.
Muscular activation of flexor and extensor muscles	The outcome will be evaluated after the treatment period (8 weeks).	Measured using the surface electromyography technique. The neuromuscular activation of flexor (rectus abdominis) and extensor (spinal erector) muscles will be measured.
Isometric muscular endurance of the trunk extensor	The outcome will be evaluated after the treatment period (8 weeks).	Measured by modified Biering-Sorensen test.
Pain intensity at 4 months follow-up	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.
Self-efficacy	The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.	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.
Work ability	The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.	Measured by a single-item question: Are you working at a physically less demanding job now because of your back and/or leg pain?
Adverse Effects	The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.	Measured by recording the number of adverse events during the intervention period.
Isometric muscular endurance of the trunk flexors	The outcome will be evaluated after the treatment period (8 weeks).	Measured by a test that consists of remaining in isometry as long as possible.
Maximum isometric strength of the trunk extensor and flexor muscles	The outcome will be evaluated after the treatment period (8 weeks).	Measured by a load cell.

Trial Locations

Locations (1)

Escola Superior de Educação Física; 🇧🇷 Pelotas, RS, Brazil