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.

Abstract

Background: Low back pain (LBP) is the leading cause of years lived with disability worldwide. Public safety workers are highly exposed to physically demanding activities and inappropriate postures, increasing the risk of experiencing LBP. Smartphone app-based self-managed interventions may be an alternative for chronic non-specific LBP (CNSLBP) treatment. This study aims to evaluate the effectiveness of a smartphone app-based self-managed exercise program plus health education, compared to a health education program alone, on neuromuscular and perceptual outcomes in police officers and firefighters with CNSLBP.

Methods: This is a parallel, two-armed, blinded evaluator randomized clinical trial. Police officers and firefighters (from public safety institutions in the Rio Grande do Sul state, Brazil) will be randomly assigned to a m-health self-managed exercise program (twice a week) plus health education or health education alone. Self-management exercise program components are mobility and core resistance exercises, available on the app. Follow-ups will be conducted post-treatment (8 weeks) and 16 weeks after randomization. The co-primary outcomes will be pain intensity and disability post-treatment (8 weeks). Secondary outcomes will be biopsychosocial factors related to CNSLBP.

Discussion: We hypothesize that the effects of a smartphone app-based self-managed exercise program on co-primary and secondary outcomes will be superior, compared to the health education only in public safety workers with CNSLBP.

Trial registration: The study was prospectively registered at ClinicalTrials.gov (NCT05481996. Registered on August 01, 2022).

Keywords: Low back pain; Mobile health; Physical exercise.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Chronic Pain* / diagnosis
  • Chronic Pain* / psychology
  • Chronic Pain* / therapy
  • Equivalence Trials as Topic
  • Exercise
  • Exercise Therapy / adverse effects
  • Exercise Therapy / methods
  • Health Education
  • Humans
  • Low Back Pain* / diagnosis
  • Low Back Pain* / therapy
  • Telemedicine*
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT05481996