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Completed

NCT Number: NCT05481996

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

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.

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Key information

Conditions

Chronic Low-back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Telerehabilitation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Escola Superior de Educação Física

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Telerehabilitation

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.

Primary outcomes

  1. Pain Intensity at post-treatment follow-up

    Time frame: 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.

  2. Disability at post-treatment follow-up

    Time frame: 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 outcomes

  1. Pain intensity at 4 months follow-up

    Time frame: 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.

  2. Disability at 4 months follow-up

    Time frame: 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.

  3. Health-Related Quality of Life

    Time frame: 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.

  4. Self-efficacy

    Time frame: 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.

  5. Depression, Anxiety and Stress

    Time frame: 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.

  6. Sleep quality

    Time frame: 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.

  7. Work ability

    Time frame: 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?

  8. Isometric muscular endurance of the trunk extensor

    Time frame: The outcome will be evaluated after the treatment period (8 weeks).

    Measured by modified Biering-Sorensen test.

  9. Isometric muscular endurance of the trunk flexors

    Time frame: 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.

  10. Maximum isometric strength of the trunk extensor and flexor muscles

    Time frame: The outcome will be evaluated after the treatment period (8 weeks).

    Measured by a load cell.

  11. Muscular activation of flexor and extensor muscles

    Time frame: 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.

  12. Adverse Effects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Federal University of Pelotas

Other

Registry information

Official study title

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

Acronym: SAFEBACK

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2022
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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