Abstract
BackgroundChronic musculoskeletal pain is one of the main causes of years lived with disability and generates the highest cost of health care among chronic pain conditions. Internet-based treatments have been shown to be an alternative for the treatment of musculoskeletal conditions, in addition to reducing barriers such as travel, high demands on the public health system, lack of time, lack of insurance coverage for private care, and high costs for long-term treatment. 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.MethodsThis is a prospectively registered, assessor-blinded, two-arm randomised controlled trial with economic evaluation comparing the Internet-based pain education and exercise intervention with a control group that will receive an online booklet. One hundred and sixty patients will be recruited from Sao Paulo, Brazil. Follow-ups will be conducted in post-treatment, 6 and 12 months after randomisation. The conduct of the study, as well as the evaluations and follow-ups will be carried out entirely remotely, through online platforms and telephone calls. The primary outcome will be pain intensity at post-treatment (8 weeks) measured using the 11-item Pain Numerical Rating Scale. Secondary outcomes will be biopsychosocial factors presents in the chronic musculoskeletal pain condition. Costs due to chronic musculoskeletal pain will be also measured, and cost-effectiveness analysis from a societal perspective will performed.DiscussionOur hypothesis is that internet-based pain education and exercise will be better than an online booklet in reducing pain and improving biopsychosocial outcomes in patients with chronic musculoskeletal pain. In addition, we believe that there will be good acceptance of patients for the internet-based intervention and that internet-based intervention will be more cost effective than the online booklet.Trial registrationThe study was prospectively registered at ClinicalTrials.gov (NCT04274439, registered 18 February 2020).
Highlights
Chronic musculoskeletal pain is one of the main causes of years lived with disability and generates the highest cost of health care among chronic pain conditions
Our hypothesis is that internet-based pain education and exercise will be better than an online booklet in reducing pain and improving biopsychosocial outcomes in patients with chronic musculoskeletal pain
Musculoskeletal pain is responsible for the highest overall healthcare costs of all chronic pain conditions, with most of the costs related to the use of outpatient services [9]
Summary
Elaboration protocol This study protocol follows the recommendations of the SPIRIT Statement [25] for clinical trial protocols elaboration and is reported according to the CONSORT Statement [26]. The content of this intervention will include videos and animations based on pain education, physical activity promotion and general exercises. Control group (online booklet) The patients allocated to the control group will have access to an online booklet containing general information about selfmanagement of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of physical activity They will receive one phone call at week 4 and motivational text messages once a week during the study period. We will use the ‘mediation’ R package to conduct these analyses [42]
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