Splinting for thumb carpometacarpal osteoarthritis: protocol for a feasibility randomized controlled trial

Abstract

Splinting for thumb carpometacarpal osteoarthritis: protocol for a feasibility randomised controlled trial Background: Evidence for the use of splints to reduce pain and improve function and quality of life in thumb carpometacarpal osteoarthritis (CMC OA) is sparse and poor despite recommendations by international guidelines. Objective: To outline the protocol for a study designed to determine the feasibility of conducting a fully powered pragmatic randomised controlled trial (RCT) comparing soft splint vs no splint for thumb CMC OA. Methods: The proposed pragmatic, assessor-blinded, and partial participant blinded parallelgroup feasibility RCT will recruit 30 adults with thumb CMC OA and randomise to: splint intervention or usual care control. Randomisation will be stratified by hand dominance. Primary feasibility outcomes are recruitment rate over a 4-month period, retention rate at 6 months, intervention acceptability, and rate of adverse events. Study costs, intervention fidelity, and clinical outcomes will also be evaluated. Measurements will be collected at baseline, 4 weeks, and 6 months post-initiation of treatment. This trial has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12618001639213. Major Findings: N/A Conclusions: If shown to be effective, soft off-the shelf splints would be a good first-line nonpharmacological, non-surgical option for thumb CMC OA as prescribed by health professionals or accessed directly by patients. This feasibility study will inform a future, fully powered RCT as evaluated by success of the recruitment strategy; assessment time and acceptability; implementation and evaluation of 'usual care'; and intervention procedures and adherence.

HAILO: A Sensorised Hand Splint for the Exploration of Interface Forces

“…Studies have shown improvements in hand function and reduced pain [12], [13], but no significant difference has been found between splinting types [14]- [16]. This has led to a questioning of the clinical effectiveness of splints due to a paucity of information on the subject [17], [18], as some commonly used splints offer littleto-no mechanical support to the joint. This highlights a need for improved understanding of splint mechanics and an opportunity to use sensing technology to assess this through measurement of the splint-hand interaction forces.…”