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

NCT05481996 | Completed

• 1 other identifier: 58715422.3.0000.5313
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain; Telerehabilitation

Keywords

low back pain; Telerehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Pain intensity at 4 months follow-up

  4 months follow-up

• Disability at 4 months follow-up

  4 months follow-up

• 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.

• 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

  The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.

Study Arms (2)

App-Based Pain Education and Exercise

EXPERIMENTAL

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

Online Booklet

ACTIVE COMPARATOR

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

Interventions

App-Based Pain Education and Exercise OTHER

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.

Also known as: Telerehabilitation

App-Based Pain Education and Exercise

Online booklet OTHER

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.

Online Booklet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

Escola Superior de Educação Física

Pelotas, Rio Grande do Sul, 96055-630, Brazil

Location

Related Publications (1)

• 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.

  PMID: 38041180 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise; Telerehabilitation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Cristine Alberton, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: October 10, 2022
• Primary Completion: June 20, 2023
• Study Completion: August 20, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)