Efficacy of combined conservative therapies on clinical outcomes in patients with thumb base osteoarthritis: protocol for a randomised, controlled trial (COMBO)

Abstract

IntroductionManagement 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.Methods and analysisThis 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.Ethics and disseminationThis 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.Trial registration numberACTRN12616000353493; Pre-results.

Association of Comorbid Interphalangeal Joint Pain and Erosive Osteoarthritis With Worse Hand Function in Individuals With Symptomatic Thumb Base Osteoarthritis

“…We conducted an exploratory analysis of baseline data from the Efficacy of Combined Conservative Therapies on Clinical Outcomes in Base of Thumb Osteoarthritis (COMBO) Trial . COMBO was a randomized controlled trial assessing the efficacy of a combination of conservative therapies for thumb base OA, including education about OA and joint protection, hand exercises, a splint for the base of the thumb, and diclofenac sodium gel over 6 weeks, compared to education and joint protection alone.…”

“…We also excluded participants who had the following: hand surgery in the previous 6 months; intraarticular hyaluronic acid injection in the affected joint in the previous 6 months; intraarticular steroid injection in the affected joint in the previous month; significant injury to the affected joint in the previous 6 months; and any other self‐reported hand condition likely contributing to the pain at the base of the thumb (e.g., scaphoid fracture, carpal tunnel syndrome, DeQuervain's tendinopathy, trigger thumb, joint infection, diabetic neuropathy, pain referred from the neck, pain following hand or wrist trauma or surgery). Additional exclusion criteria have been described in the trial's protocol .…”

Radial subluxation in relation to hand strength and radiographic severity in trapeziometacarpal osteoarthritis

“…This study is an exploratory analysis of baseline data from the first 100 participants included in the COMBO trial (Efficacy of combined conservative therapies on clinical outcomes in base of thumb OA; ACTRN12616000353493) 18 . The COMBO trial is a randomised, controlled trial designed to assess the efficacy of a combination of education about joint protection and OA, splint for the base of thumb, hand exercises, and diclofenac sodium 1% gel vs education about joint protection and OA alone.…”

“…If pain scores were the same in both hands, then the participant nominated the index hand as the one that caused more functional impairment. A detailed description of the inclusion and exclusion criteria has previously been reported 18 . The study design was approved by the local ethics committee (HREC/15/HAWKE/479).…”

Class IV laser therapy for trapeziometacarpal joint osteoarthritis: Study protocol for a randomized placebo‐controlled trial

“…Scientific background to support therapeutic management of patient with TCMC-OA exists at various levels of evidence. The traditional mainstay for conservative therapeutic management includes orthotic support (Hermann et al, 2014), pharmacological approach (Joshi, 2005;Salini, De Amicis, Abate, Natale, & Di Iorio, 2009), patient education (Stamm et al, 2002), therapeutic exercise (Valdes & von der Heyde, 2012), joint (Villafañe, Silva, & Fernandez-Carnero, 2012) and neural (Villafañe, Silva, & Fernandez-Carnero, 2011) mobilization, or radiotherapy (Kaltenborn, Bulling, Nitsche, Carl, & Hermann, 2016) among others, both isolated or in combination (Deveza et al, 2017). Although a number of them have shown to be effective, most of existing trials on TCMC-OA have demonstrated poor consistent case definition, sparse standardized outcome measures, and inadequate powering, thereby limiting their generalizability to clinical scenarios (Spaans et al, 2015).…”