Back to resultsExercise-based Telerehabilitation Program for Police Officers and Firefighters With Chronic Non-specific Low Back Pain (SAFEBACK)
Primary Purpose
Chronic Low-back Pain, Telerehabilitation
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
App-Based Pain Education and Exercise
Online booklet
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low-back Pain focused on measuring low back pain, Telerehabilitation
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
Sites / Locations
- Escola Superior de Educação FísicaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
App-Based Pain Education and Exercise
Online Booklet
Arm Description
Patients allocated to the experimental group will receive a login and password for individual access to the smartphone app designed for the study. The app's content for this group will include three components: 1) a physical exercise program of 8 weeks; 2) weekly messages; and 3) an online booklet. The exercise component will include 8 weeks of training, with two sessions per week of core strengthening exercises. The app will provide illustrations, with animated images (GIFs), descriptions and audios of how to perform each exercise. The message component will provide eight messages (one per week), which will have their contents taken from the online booklet. Messages will include information about the benefits of exercise, motivation, and positive messages about coping with pain. The online booklet will contain general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises.
Patients allocated to the control group will receive a login and password for individual access to the smartphone app designed for the study. The app's content for this group will include two components: 1) an online booklet; and 2) weekly messages. The online booklet will contain general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises. The message component will provide eight messages (one per week), which will have their contents taken from the online booklet. Messages will include information about the benefits of exercise, motivation, and positive messages about coping with pain.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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?
Isometric muscular endurance of the trunk extensor
Measured by modified Biering-Sorensen test.
Isometric muscular endurance of the trunk flexors
Measured by a test that consists of remaining in isometry as long as possible.
Maximum isometric strength of the trunk extensor and flexor muscles
Measured by a load cell.
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.
Adverse Effects
Measured by recording the number of adverse events during the intervention period.
Full Information
NCT ID
NCT05481996
First Posted
July 28, 2022
Last Updated
May 3, 2023
Sponsor
Federal University of Pelotas
1. Study Identification
Unique Protocol Identification Number
NCT05481996
Brief Title
Exercise-based Telerehabilitation Program for Police Officers and Firefighters With Chronic Non-specific Low Back Pain
Acronym
SAFEBACK
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
June 20, 2023 (Anticipated)
Study Completion Date
August 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Pelotas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain, Telerehabilitation
Keywords
low back pain, Telerehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
App-Based Pain Education and Exercise
Arm Type
Experimental
Arm Description
Patients allocated to the experimental group will receive a login and password for individual access to the smartphone app designed for the study. The app's content for this group will include three components: 1) a physical exercise program of 8 weeks; 2) weekly messages; and 3) an online booklet. The exercise component will include 8 weeks of training, with two sessions per week of core strengthening exercises. The app will provide illustrations, with animated images (GIFs), descriptions and audios of how to perform each exercise. The message component will provide eight messages (one per week), which will have their contents taken from the online booklet. Messages will include information about the benefits of exercise, motivation, and positive messages about coping with pain. The online booklet will contain general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises.
Arm Title
Online Booklet
Arm Type
Active Comparator
Arm Description
Patients allocated to the control group will receive a login and password for individual access to the smartphone app designed for the study. The app's content for this group will include two components: 1) an online booklet; and 2) weekly messages. The online booklet will contain general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises. The message component will provide eight messages (one per week), which will have their contents taken from the online booklet. Messages will include information about the benefits of exercise, motivation, and positive messages about coping with pain.
Intervention Type
Other
Intervention Name(s)
App-Based Pain Education and Exercise
Other Intervention Name(s)
Telerehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Online booklet
Intervention Description
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 Outcome Measure Information:
Title
Pain Intensity at post-treatment follow-up
Description
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.
Time Frame
Post-treatment follow-up (8 weeks)
Title
Disability at post-treatment follow-up
Description
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.
Time Frame
Post-treatment follow-up (8 weeks)
Secondary Outcome Measure Information:
Title
Pain intensity at 4 months follow-up
Description
Measured using the Pain Numerical Rating Scale, a numerical scale of 11 domains, where 0 indicates no pain and 10 indicates maximum pain intensity.
Time Frame
4 months follow-up
Title
Disability at 4 months follow-up
Description
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.
Time Frame
4 months follow-up
Title
Health-Related Quality of Life
Description
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.
Time Frame
The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Title
Self-efficacy
Description
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.
Time Frame
The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Title
Depression, Anxiety and Stress
Description
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.
Time Frame
The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Title
Sleep quality
Description
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.
Time Frame
The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Title
Work ability
Description
Measured by a single-item question: Are you working at a physically less demanding job now because of your back and/or leg pain?
Time Frame
The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
Title
Isometric muscular endurance of the trunk extensor
Description
Measured by modified Biering-Sorensen test.
Time Frame
The outcome will be evaluated after the treatment period (8 weeks).
Title
Isometric muscular endurance of the trunk flexors
Description
Measured by a test that consists of remaining in isometry as long as possible.
Time Frame
The outcome will be evaluated after the treatment period (8 weeks).
Title
Maximum isometric strength of the trunk extensor and flexor muscles
Description
Measured by a load cell.
Time Frame
The outcome will be evaluated after the treatment period (8 weeks).
Title
Muscular activation of flexor and extensor muscles
Description
Measured using the surface electromyography technique. The neuromuscular activation of flexor (rectus abdominis) and extensor (spinal erector) muscles will be measured.
Time Frame
The outcome will be evaluated after the treatment period (8 weeks).
Title
Adverse Effects
Description
Measured by recording the number of adverse events during the intervention period.
Time Frame
The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo F Marins, PhD Student
Phone
+55 53 981434610
Email
dudufrio@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo L Caputo, PhD
Phone
+55 53 8162-2442
Email
caputoeduardo@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristine Alberton, PhD
Organizational Affiliation
Federal University of Pelotas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Escola Superior de Educação Física
City
Pelotas
State/Province
RS
ZIP/Postal Code
96055-630
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristine L Alberton, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mdpi.com/2071-1050/12/19/7922
Description
Conservative Interventions for Non-Specific Low Back Pain in Tactical Populations: A Systematic Review of Randomized Controlled Trials
Learn more about this trial
Exercise-based Telerehabilitation Program for Police Officers and Firefighters With Chronic Non-specific Low Back Pain
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