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

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

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 Overview

• Status: Completed
• Conditions: Chronic Low-back Pain; Telerehabilitation
• Intervention / Treatment: Other: App-Based Pain Education and Exercise; Other: Online booklet

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Pelotas, RS, Brazil, 96055-630
      • Escola Superior de Educação Física

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: App-Based Pain Education and Exercise; 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.; Other Names: Telerehabilitation
Active Comparator: 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.	Other: Online booklet; 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.

What is the study measuring?

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).
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.
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).

Collaborators and Investigators

• Sponsor: Federal University of Pelotas
• Investigators: Principal Investigator: Cristine Alberton, PhD, Federal University of Pelotas

Publications and helpful links

General Publications

• Marins EF, Caputo EL, Kruger VL, Junior DM, Scaglioni FG, Del Vecchio FB, Primo TT, Alberton CL. Effectiveness of m-health-based core strengthening exercise and health education for public safety workers with chronic non-specific low back pain: study protocol for a superiority randomized controlled trial (SAFEBACK). Trials. 2023 Dec 1;24(1):780. doi: 10.1186/s13063-023-07833-9.

Helpful Links

• Conservative Interventions for Non-Specific Low Back Pain in Tactical Populations: A Systematic Review of Randomized Controlled Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): August 20, 2023

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: low back pain; Telerehabilitation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 58715422.3.0000.5313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No