title: Does occupational therapy reduce the need for surgery in carpometacarpal osteoarthritis? Protocol for a randomized controlled trial.
abstract: In 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?
  
  
  
  All 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.
  
  
  
  The findings will improve the evidence-based management of HOA.
  
  
  
  NCT01794754 . First registrated February 15th2013.
authors.affiliation: National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, PO Box 23, Vinderen, N-0319, Oslo, Norway. ingvild.kjeken@diakonsyk.no.
authors.forename: Ingvild
authors.identifier: 0000-0002-3971-2852
authors.initials: I
authors.lastname: Kjeken
authors.affiliation: Department of Rheumatology, Haukeland University Hospital, Bergen, Norway.
authors.forename: Ruth Else Mehl
authors.initials: RE
authors.lastname: Eide
authors.affiliation: Haugesund Rheumatism Hospital, Haugesund, Norway.
authors.forename: Åse
authors.initials: Å
authors.lastname: Klokkeide
authors.affiliation: Department of Rheumatology, Haukeland University Hospital, Bergen, Norway.
authors.forename: Karin Hoegh
authors.initials: KH
authors.lastname: Matre
authors.affiliation: Haugesund Rheumatism Hospital, Haugesund, Norway.
authors.forename: Monika
authors.initials: M
authors.lastname: Olsen
authors.affiliation: National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, PO Box 23, Vinderen, N-0319, Oslo, Norway.
authors.forename: Petter
authors.initials: P
authors.lastname: Mowinckel
authors.affiliation: Patient research panel, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
authors.forename: Øyvor
authors.initials: Ø
authors.lastname: Andreassen
authors.affiliation: Department of Clinical Services, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.
authors.forename: Siri
authors.initials: S
authors.lastname: Darre
authors.affiliation: Department of Clinical Services, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.
authors.forename: Randi
authors.initials: R
authors.lastname: Nossum
mesh_terms: D052737:Carpometacarpal Joints / Q000473:pathology* / Q000601:surgery*; D003362:Cost-Benefit Analysis; D006225:Hand / Q000503:physiopathology; D006801:Humans; D009664:Norway; D009788:Occupational Therapy / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D019637:Orthopedic Procedures / Q000009:adverse effects* / Q000191:economics / Q000379:methods; D009989:Orthotic Devices; D010003:Osteoarthritis / Q000150:complications / Q000534:rehabilitation* / Q000601:surgery*; D010146:Pain / Q000209:etiology / Q000601:surgery; D017060:Patient Satisfaction; D016059:Range of Motion, Articular; D016896:Treatment Outcome
keywords: Assistive devices; Cost-effectiveness; Exercises; Hand osteoarthritis; Occupational therapy; Orthoses; Surgery