Back to resultsEffectiveness and Cost-Effectiveness of a Tele-Rehabilitation Program in the Treatment of Chronic Musculoskeletal Pain
Primary Purpose
Chronic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Internet-Based Pain Education and Exercise
Online Booklet
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, Telerehabilitation, Telemedicine, Physical Therapy
Eligibility Criteria
Inclusion Criteria:
- Aged between 18 and 60 years
- Seeking treatment for any chronic musculoskeletal pain of at least 3 points in a 0 to 10 Pain Numerical Rating Scale
- Able to read and understand Portuguese
With internet access.
- Chronic Pain will be defined as pain lasting more than 12 weeks.
Exclusion Criteria:
- Present neurological symptoms (nerve root compromise, or sensation deficits)
- Present serious spinal pathologies (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 orthopaedic surgery (over the last 12 months)
- Scheduled to undergo surgery in the next 6 months, or pregnancy
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
- Rua Cesário Galeno, 448/475Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Internet-Based Pain Education and Exercise
Online Booklet
Arm Description
Patients allocated to the intervention group will receive a login and password for individual access to the website designed for the study. The content of this intervention will include videos and animations based on pain education, physical activity promotion and general exercises. The pain education component will be based on the E-pain intervention developed by Reis et al (2017), which includes nine main features: (1) acceptance, (2 and 3) education about pain, (4) sleep hygiene, (5) recognizing stress and negative emotions, (6) increasing positive coping in lifestyle, (7) exercises, (8) communication and (9) relapse prevention. The exercise component will include general exercises aiming to improve strength, flexibility, control and coordination. Patients in this group will also receive weekly text messages and a health coaching over the telephone. The text messages will include information on the benefits of exercises, motivation, and positive messages about dealing with pain.
The patients allocated to the control group will have access to an online booklet containing general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises. They will also receive one phone call at week 4 and text messages once a week during the study period.
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.
Secondary Outcome Measures
Pain intensity at 6 months and 12 months follow-up
TMeasured using the Pain Numerical Rating Scale, a numerical scale of 11 domains, where 0 indicates no pain and 10 indicates maximum pain intensity.
Function
Measured with the Patient Specific Functional Scale, a self-reported scale specific for the measurement of functionality in musculoskeletal injuries, where the patient classifies his activities from 0 to 10, being 0 the inability to perform that function and 10 the total capacity to perform the function;
Health-Related Quality of Life
Measured with the SF-12, a self-reported questionnaire with 12 questions and classification of 8 different dimensions related to quality of life. Higher scores define better quality of life;
Kinesiophobia
Measured with the Tampa Scale of Kinesiophobia, a self-reported questionnaire with 17 questions, where the patient ranks "totally disagree" statements equivalent to one point, "partially disagree", two points, "partially agree", three points and "totally agree", four points . Higher scores at the end of the questionnaire identify worse results in kinesiophobia outcome;
Global Perceived Effect
Measured with the Global Perceived Effect Scale, a self-reported scale, with scores of -5 to 5, where the progression of the patient's condition will be classified from a certain point in time. Scores of -5 indicate a lot of worsening and scores of 5 indicate a lot of improvement.
Anxiety and Depression
Measured by the Hospital Anxiety and Depression Scale, a self-reported scale with 14 questions, 7 for depression and 7 for anxiety. Each question has a rating ranging from 0 to 3 according to the patient's response. Scores near 21 indicate the worst results.
Pain Catastrophisation
Measured with the Pain Catastrophising Scale, a self-reported scale with 13 statements, where the patient ranks the affirmations between 0 being "minimal" to 4 "very intense." The calculation of the final score is based on 3 subdomains of the scale and scores closer to 52 indicate worse results.
Pain-related Attitudes and Beliefs
Measured with Orebro Musculoskeletal Pain Questionnaire, a self-reported questionnaire with questions related to musculoskeletal pain classified from 0 to 10 and its score calculated later according to these answers and using an own algorithm of the questionnaire.
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.
Adverse Effects
Measured by recording the number of adverse events during the intervention period.
Full Information
NCT ID
NCT04274439
First Posted
May 9, 2019
Last Updated
March 24, 2020
Sponsor
Universidade Cidade de Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT04274439
Brief Title
Effectiveness and Cost-Effectiveness of a Tele-Rehabilitation Program in the Treatment of Chronic Musculoskeletal Pain
Official Title
Effectiveness and Cost-Effectiveness of a Tele-Rehabilitation Program in the Treatment of Chronic Musculoskeletal Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
September 2, 2021 (Anticipated)
Study Completion Date
March 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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 and cost-effectiveness of an internet-based self-management program based on pain education and exercise for people with chronic musculoskeletal pain.
Detailed Description
Chronic pain is a major burden on the individual and society. It is estimated that about one third of the adult population worldwide suffer from chronic pain, with higher prevalence rates reported for low-income countries. Internet-based self-management programs have grown with the development of new technologies and have been extensively used for delivering healthcare in many areas. However, there is still little research on the development and testing of remotely-delivered programs for the management of chronic musculoskeletal pain, especially in low and mid-income countries. The aim of this clinical trial is to develop and test the effectiveness and cost-effectiveness of an internet-based self-management program based on pain education and exercise for people with chronic musculoskeletal pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic Pain, Telerehabilitation, Telemedicine, Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a controlled clinical trial, with the Intervention group performing the 8-week follow-up and access to 8 pain education videos and 8 exercise videos prescribed for patients with chronic pain, and the control group receiving information on chronic pain for one booklet. Randomized through site programming, so that the subject enters his / her login and password and is directed to one of the study groups, with blind evaluator without access to randomization information throughout the course of the study and follow-up of the outcome measures for 3 , 6 and 12 months after randomization.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Internet-Based Pain Education and Exercise
Arm Type
Experimental
Arm Description
Patients allocated to the intervention group will receive a login and password for individual access to the website designed for the study. The content of this intervention will include videos and animations based on pain education, physical activity promotion and general exercises. The pain education component will be based on the E-pain intervention developed by Reis et al (2017), which includes nine main features: (1) acceptance, (2 and 3) education about pain, (4) sleep hygiene, (5) recognizing stress and negative emotions, (6) increasing positive coping in lifestyle, (7) exercises, (8) communication and (9) relapse prevention. The exercise component will include general exercises aiming to improve strength, flexibility, control and coordination.
Patients in this group will also receive weekly text messages and a health coaching over the telephone. The text messages will include information on the benefits of exercises, motivation, and positive messages about dealing with pain.
Arm Title
Online Booklet
Arm Type
Active Comparator
Arm Description
The patients allocated to the control group will have access to an online booklet containing general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises. They will also receive one phone call at week 4 and text messages once a week during the study period.
Intervention Type
Other
Intervention Name(s)
Internet-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 website created and registered especially for the study that will have the shooting of 1 video of pain education and 1 video of exercises for the subjects of the study, totaling 8 videos of pain education and 8 exercise videos. We will provide complimentary materials along with the triggered videos and a booklet of chronic pain information. We will also make weekly calls for a health coaching service and the sending of smartphone messages for the motivation and accountability of the subjects.
Intervention Type
Other
Intervention Name(s)
Online Booklet
Intervention Description
An online booklet containing information about chronic pain and 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)
Secondary Outcome Measure Information:
Title
Pain intensity at 6 months and 12 months follow-up
Description
TMeasured 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
6 months and 12 months follow-up
Title
Function
Description
Measured with the Patient Specific Functional Scale, a self-reported scale specific for the measurement of functionality in musculoskeletal injuries, where the patient classifies his activities from 0 to 10, being 0 the inability to perform that function and 10 the total capacity to perform the function;
Time Frame
The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.
Title
Health-Related Quality of Life
Description
Measured with the SF-12, a self-reported questionnaire with 12 questions and classification of 8 different dimensions related to quality of life. Higher scores define better quality of life;
Time Frame
The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.
Title
Kinesiophobia
Description
Measured with the Tampa Scale of Kinesiophobia, a self-reported questionnaire with 17 questions, where the patient ranks "totally disagree" statements equivalent to one point, "partially disagree", two points, "partially agree", three points and "totally agree", four points . Higher scores at the end of the questionnaire identify worse results in kinesiophobia outcome;
Time Frame
The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.
Title
Global Perceived Effect
Description
Measured with the Global Perceived Effect Scale, a self-reported scale, with scores of -5 to 5, where the progression of the patient's condition will be classified from a certain point in time. Scores of -5 indicate a lot of worsening and scores of 5 indicate a lot of improvement.
Time Frame
The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.
Title
Anxiety and Depression
Description
Measured by the Hospital Anxiety and Depression Scale, a self-reported scale with 14 questions, 7 for depression and 7 for anxiety. Each question has a rating ranging 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), after 6 months of randomization and after 12 months of randomization of each subject.
Title
Pain Catastrophisation
Description
Measured with the Pain Catastrophising Scale, a self-reported scale with 13 statements, where the patient ranks the affirmations between 0 being "minimal" to 4 "very intense." The calculation of the final score is based on 3 subdomains of the scale and scores closer to 52 indicate worse results.
Time Frame
The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.
Title
Pain-related Attitudes and Beliefs
Description
Measured with Orebro Musculoskeletal Pain Questionnaire, a self-reported questionnaire with questions related to musculoskeletal pain classified from 0 to 10 and its score calculated later according to these answers and using an own algorithm of the questionnaire.
Time Frame
The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 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), after 6 months of randomization and after 12 months of randomization of each subject.
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), after 6 months of randomization and after 12 months of randomization of each subject.
Other Pre-specified Outcome Measures:
Title
Patient's Expectancy for Improvement at Baseline
Description
Expectancy of Improvement Numerical Scale.
Time Frame
The outcome will be evaluated at the baseline
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
Seeking treatment for any chronic musculoskeletal pain of at least 3 points in a 0 to 10 Pain Numerical Rating Scale
Able to read and understand Portuguese
With internet access.
Chronic Pain will be defined as pain lasting more than 12 weeks.
Exclusion Criteria:
Present neurological symptoms (nerve root compromise, or sensation deficits)
Present serious spinal pathologies (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 orthopaedic surgery (over the last 12 months)
Scheduled to undergo surgery in the next 6 months, or pregnancy
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
Iuri Fioratti, PhD Student
Phone
55 11 970127143
Email
iurifioratti@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno T Saragiotto, PostDoc
Phone
55 11 999105890
Email
bruno.saragiotto@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno T Saragiotto, PostDoc
Organizational Affiliation
Universidade Cidade de Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rua Cesário Galeno, 448/475
City
São Paulo
ZIP/Postal Code
03071-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iuri Fioratti, Pt
Phone
55 11 970127143
Email
iurifioratti@gmail.com
First Name & Middle Initial & Last Name & Degree
Bruno Saragiotto, PhD
Email
bruno.saragiotto@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We can share our data upon request.
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Effectiveness and Cost-Effectiveness of a Tele-Rehabilitation Program in the Treatment of Chronic Musculoskeletal Pain
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