Does occupational therapy reduce the need for surgery in carpometacarpal osteoarthritis? Protocol for a randomized controlled trial

BMC Musculoskeletal Disorders

Study Protocol

Siri Darre¹  Randi Nossum¹  Karin Hoegh Matre²  Ruth Else Mehl Eide²  Monika Olsen³  Åse Klokkeide³  Petter Mowinckel⁴  Ingvild Kjeken⁴  Øyvor Andreassen⁵ 

[1] Department of Clinical Services, St. Olav’s Hospital, Trondheim University Hospital, Trondheim, Norway;Department of Rheumatology, Haukeland University Hospital, Bergen, Norway;Haugesund Rheumatism Hospital, Haugesund, Norway;National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, PO Box 23, Vinderen, N-0319, Oslo, Norway;Patient research panel, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway;

关键词: Hand osteoarthritis;    Occupational therapy;    Surgery;    Exercises;    Assistive devices;    Orthoses;    Cost-effectiveness;   

DOI  :  10.1186/s12891-016-1321-3

 received in 2016-10-15, accepted in 2016-11-01,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundIn the absence of disease-modifying interventions for hand osteoarthritis (OA), occupational therapy (OT) comprising patient education, hand exercises, assistive devices and orthoses are considered as core treatments, whereas surgery are recommended for those with severe carpometacarpal (CMC1) OA. However, even though CMC1 surgery may reduce pain and improve function, the risk of adverse effects is high, and randomized controlled trials comparing surgery with non-surgical interventions are warranted.This multicentre randomized controlled trial aims to address the following questions:Does OT in the period before surgical consultation reduce the need for surgery in CMC1-OA?What are patients’ motivation and reasons for wanting CMC1-surgery?Are there differences between departments of rheumatology concerning the degree of CMC1-OA, pain and functional limitations in patients who are referred for surgical consultation for CMC1 surgery?Is the Measure of Activity Performance of the Hand a reliable measure in patients with CMC1-OA?Do patients with CMC1-OA with and without affection of the distal and proximal interphalangeal finger joints differ with regard to symptoms and function?Do the degree of CMC1-OA, symptoms and functional limitations significantly predict improvement after 2 years following OT or CMC1-surgery?Is OT more cost-effective than surgery in the management of CMC1-OA?Methods/DesignAll persons referred for surgical consultation due to their CMC1-OA at one of three Norwegian departments of rheumatology are invited to participate. Those who agree attend a clinical assessment and report their symptoms, function and motivation for surgery in validated outcome measures, before they are randomly selected to receive OT in the period before surgical consultation (estimated n = 180). The primary outcome will be the number of participants in each group who have received surgical treatment after 2 years. Secondary and tertiary outcomes are pain, function and satisfaction with care over the 2-year trial period. Outcomes will be collected at baseline, 4, 18 and 24 months. The main analysis will be on an intention-to-treat basis, using logistic regression, comparing the number of participants in each group who have received surgical treatment after 2 years.DiscussionThe findings will improve the evidence-based management of HOA.Trial registration identifierNCT01794754. First registrated February 15th 2013.

【 授权许可】

CC BY   
© The Author(s). 2016