Chronic Pain
Conditions
Keywords
Chronic Pain, Telerehabilitation, Telemedicine, Physical Therapy
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.
Interventions
OTHERInternet-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 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.
OTHEROnline Booklet
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.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Universidade Cidade de Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity at 6 months and 12 months follow-up | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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. |
| Pain Catastrophisation | 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. | 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 | 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. | 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 | 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. | 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 | 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. | Measured by recording the number of adverse events during the intervention period. |
| Anxiety and Depression | 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient's Expectancy for Improvement at Baseline | The outcome will be evaluated at the baseline | Expectancy of Improvement Numerical Scale. |
Countries
Brazil
Contacts
Primary ContactIuri Fioratti, PhD Student
Backup ContactBruno T Saragiotto, PostDoc
Outcome results
None listed