Chronic Low-back Pain Clinical Trial
— SAFEBACKOfficial title:
Effectiveness of an Exercise-based Telerehabilitation Program for Police Officers and Firefighters With Chronic Non-specific Low Back Pain: a Randomized Clinical Trial
Verified date | February 2024 |
Source | Federal University of Pelotas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Escola Superior de Educação Física | Pelotas | RS |
Lead Sponsor | Collaborator |
---|---|
Federal University of Pelotas |
Brazil,
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
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. |
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