Clinical trial NCT04274439: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
Telerehabilitation
Telemedicine
Physical Therapy
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2020-02-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain Intensity at post-treatment follow-up
timeFrame: Post-treatment follow-up (8 weeks)
Secondary outcomes:
measure: Pain intensity at 6 months and 12 months follow-up
timeFrame: 6 months and 12 months follow-up
measure: Function
timeFrame: 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.
measure: Health-Related Quality of Life
timeFrame: 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.
measure: Kinesiophobia
timeFrame: 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.
measure: Global Perceived Effect
timeFrame: 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.
measure: Anxiety and Depression
timeFrame: 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.
measure: Pain Catastrophisation
timeFrame: 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.
measure: Pain-related Attitudes and Beliefs
timeFrame: 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.
measure: Self-efficacy
timeFrame: 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.
measure: Adverse Effects
timeFrame: 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 outcomes:
measure: Patient's Expectancy for Improvement at Baseline
timeFrame: The outcome will be evaluated at the baseline
Locations:
city: São Paulo
country: Brazil
facility: Rua Cesário Galeno, 448/475
Study officials:
affiliation: Universidade Cidade de Sao Paulo
name: Bruno T Saragiotto, PostDoc
role: PRINCIPAL_INVESTIGATOR
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