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

Chronic Low-back Pain Clinical Trial

— SAFEBACK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05481996
• Other study ID #: 58715422.3.0000.5313
• Status: Completed
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: August 20, 2023

Study information

• Verified date: February 2024
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain
• Telerehabilitation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Escola Superior de Educação Física	Pelotas	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Isometric muscular endurance of the trunk extensor	Measured by modified Biering-Sorensen test.	The outcome will be evaluated after the treatment period (8 weeks).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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.

External Links

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