title: Efficacy of combined conservative therapies on clinical outcomes in patients with thumb base osteoarthritis: protocol for a randomised, controlled trial (COMBO).
abstract: Management of thumb base osteoarthritis (OA) using a combination of therapies is common in clinical practice; however, evidence for the efficacy of this approach is lacking. The aim of this study is to determine the effect of a combination of conservative therapies for the treatment of thumb base OA compared with an education control group.
  
  
  
  This is a randomised, controlled, single-centre, two-arm superiority trial with 1:1 allocation ratio; with assessor and statistician blinded. Participants are blinded to the trial's hypothesis and to the interventions received by the opposite group. A total of 204 participants will be recruited from the community and randomised using a computer-generated schedule. The intervention group will receive education for joint protection and OA, a splint for the base of the thumb, hand exercises and topical diclofenac sodium 1% gel over 6 weeks. The control group will receive education for joint protection and OA alone. Main inclusion criteria are pain ≥40 mm (Visual Analogue Scale, 0-100) at the base of the thumb, impairment in hand function ≥6 (Functional Index for Hand Osteoarthritis, 0-30) and radiographic thumb base OA (Kellgren Lawrence grade ≥2). Participants currently receiving any of the intervention components will be excluded. Outcomes will be measured at 2, 6 and 12 weeks. The primary outcome is change in pain and hand function from baseline to 6 weeks. Other outcomes include changes in grip and pinch strength, quality of life, presence of joint swelling and tenderness, duration of joint stiffness, patient's global assessment and use of rescue medication. Analysis will be performed according to the intention-to-treat principle. Adverse events will be monitored throughout the study.
  
  
  
  This protocol is approved by the local ethics committee (HREC/15/HAWKE/479). Dissemination will occur through presentations at international conferences and publication in peer-reviewed journals.
  
  
  
  ACTRN12616000353493; Pre-results.
authors.affiliation: Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Leticia A
authors.initials: LA
authors.lastname: Deveza
authors.affiliation: Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: David J
authors.identifier: 0000-0003-3197-752X
authors.initials: DJ
authors.lastname: Hunter
authors.affiliation: Macquarie University Clinic, Macquarie Hand Therapy, Macquarie University, New South Wales, Australia.
authors.forename: Anne
authors.initials: A
authors.lastname: Wajon
authors.affiliation: Department of Physiotherapy, Centre for Health, Exercise and Sports Medicine, School of Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Kim L
authors.initials: KL
authors.lastname: Bennell
authors.affiliation: School of Health and Rehabilitation Sciences: Physiotherapy, The University of Queensland, Brisbane, St. Lucia, Australia.
authors.forename: Bill
authors.initials: B
authors.lastname: Vicenzino
authors.affiliation: School of Health and Rehabilitation Sciences: Physiotherapy, The University of Queensland, Brisbane, St. Lucia, Australia.
authors.forename: Paul
authors.initials: P
authors.lastname: Hodges
authors.affiliation: Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Jillian P
authors.initials: JP
authors.lastname: Eyles
authors.affiliation: Physiotherapy Department, Royal North Shore Hospital, Sydney, New South Wales, Australia.
authors.forename: Ray
authors.initials: R
authors.lastname: Jongs
authors.affiliation: Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Edward A
authors.initials: EA
authors.lastname: Riordan
authors.affiliation: Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Vicky
authors.initials: V
authors.lastname: Duong
authors.affiliation: Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Win
authors.initials: W
authors.lastname: Min Oo
authors.affiliation: National Health and Medical Research Council (NHMRC) Clinical Trial Centre, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Rachel
authors.initials: R
authors.lastname: O'Connell
authors.affiliation: Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Sarah R F
authors.initials: SR
authors.lastname: Meneses
mesh_terms: D000368:Aged; D001315:Australia / Q000453:epidemiology; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D000072700:Conservative Treatment; D005081:Exercise Therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000453:epidemiology / Q000473:pathology / Q000628:therapy*; D010146:Pain / Q000517:prevention & control*; D010147:Pain Measurement; D017410:Practice Guidelines as Topic; D011788:Quality of Life; D013933:Thumb / Q000473:pathology*; D016896:Treatment Outcome
keywords: conservative; osteoarthritis; thumb