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

NCT ID: NCT05481996

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-10

Study Completion Date

2023-08-20

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.

Conditions

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Chronic Low-back Pain Telerehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

App-Based Pain Education and Exercise

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Online booklet

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Telerehabilitation

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Pelotas

OTHER

Sponsor Role lead

Responsible Party

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Cristine Lima Alberton

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cristine Alberton, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Pelotas

Locations

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Escola Superior de Educação Física

Pelotas, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 38041180 (View on PubMed)

Other Identifiers

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58715422.3.0000.5313

Identifier Type: -

Identifier Source: org_study_id

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