TY - JOUR
T1 - Evaluation of the efficacy of an internet-based pain education and exercise program for chronic musculoskeletal pain in comparison with online self-management booklet
T2 - a protocol of a randomised controlled trial with assessor-blinded, 12-month follow-up, and economic evaluation
AU - Fioratti, Iuri
AU - Saragiotto, Bruno T.
AU - Reis, Felipe J. J.
AU - Miyamoto, Gisela C.
AU - Lee, Hopin
AU - Yamato, Tiê P.
AU - Fandim, Junior V.
AU - Dear, Blake
AU - Maher, Chris G.
AU - Costa, Leonardo O. P.
N1 - Copyright the Author(s) 2020. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.
PY - 2020/6/26
Y1 - 2020/6/26
N2 - Background: 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. 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. Methods: This 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. Discussion: 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. 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 registration: The study was prospectively registered at ClinicalTrials.gov (NCT04274439, registered 18 February 2020).
AB - Background: 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. 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. Methods: This 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. Discussion: 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. 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 registration: The study was prospectively registered at ClinicalTrials.gov (NCT04274439, registered 18 February 2020).
KW - chronic pain
KW - chronic musculoskeletal pain
KW - internet-based
KW - cost-effectiveness analysis
KW - study protocol
UR - http://www.scopus.com/inward/record.url?scp=85087181091&partnerID=8YFLogxK
U2 - 10.1186/s12891-020-03423-x
DO - 10.1186/s12891-020-03423-x
M3 - Article
C2 - 32590959
AN - SCOPUS:85087181091
SN - 1471-2474
VL - 21
JO - BMC Musculoskeletal Disorders
JF - BMC Musculoskeletal Disorders
IS - 1
M1 - 404
ER -