Clinical trial NCT05481996: Exercise-based Telerehabilitation Program for Police Officers and Firefighters With Chronic Non-specific Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Telerehabilitation
Keywords: low back pain
Telerehabilitation
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity at post-treatment follow-up
timeFrame: Post-treatment follow-up (8 weeks)
measure: Disability at post-treatment follow-up
timeFrame: Post-treatment follow-up (8 weeks)
Secondary outcomes:
measure: Pain intensity at 4 months follow-up
timeFrame: 4 months follow-up
measure: Disability at 4 months follow-up
timeFrame: 4 months follow-up
measure: Health-Related Quality of Life
timeFrame: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
measure: Self-efficacy
timeFrame: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
measure: Depression, Anxiety and Stress
timeFrame: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
measure: Sleep quality
timeFrame: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
measure: Work ability
timeFrame: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
measure: Isometric muscular endurance of the trunk extensor
timeFrame: The outcome will be evaluated after the treatment period (8 weeks).
measure: Isometric muscular endurance of the trunk flexors
timeFrame: The outcome will be evaluated after the treatment period (8 weeks).
measure: Maximum isometric strength of the trunk extensor and flexor muscles
timeFrame: The outcome will be evaluated after the treatment period (8 weeks).
measure: Muscular activation of flexor and extensor muscles
timeFrame: The outcome will be evaluated after the treatment period (8 weeks).
measure: Adverse Effects
timeFrame: The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Escola Superior de Educação Física
state: RS
Study officials:
affiliation: Federal University of Pelotas
name: Cristine Alberton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.