Chronic Low-back Pain, Telerehabilitation
Conditions
Keywords
low back pain, Telerehabilitation
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.
Interventions
OTHERApp-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.
OTHEROnline 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.
Sponsors
Federal University of Pelotas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity at post-treatment follow-up | 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. |
| Disability at post-treatment follow-up | 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
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life | 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. |
| Self-efficacy | 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. |
| Depression, Anxiety and Stress | 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. |
| Sleep quality | 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. |
| Work ability | 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? |
| Pain intensity at 4 months follow-up | 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. |
| Isometric muscular endurance of the trunk flexors | 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. |
| Maximum isometric strength of the trunk extensor and flexor muscles | The outcome will be evaluated after the treatment period (8 weeks). | Measured by a load cell. |
| Muscular activation of flexor and extensor muscles | 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. |
| Adverse Effects | 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. |
| Isometric muscular endurance of the trunk extensor | The outcome will be evaluated after the treatment period (8 weeks). | Measured by modified Biering-Sorensen test. |
| Disability at 4 months follow-up | 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. |
Countries
Brazil
Outcome results
None listed