Phase 2
N=56
CMC (Carpometacarpal) OA (Osteoarthritis) Thumb Splint Study
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00705146 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Hand Function — 5.54; 2.69 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Comfort Cool thumb splint by North Coast Medical (Device); Custom made thermoplastic & neoprene splint (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- University of British Columbia
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hand Function |
5.54; 2.69 | — |
| SECONDARY Pain |
5.69; 2.05 | — |
Summary
Osteoarthritis (OA) of the thumb carpometacarpal (CMC) joint is a common condition that is seen regularly in outpatient occupational therapy and physiotherapy departments. Prevalence rates of symptomatic thumb OA have been found to be as high as 25%. The conservative treatment of choice consists of splinting. There are many different types of thumb splints available, but no specific guidelines as to which is preferred. There is limited evidence to support the benefits of splinting.
The purpose of this study is to compare the effectiveness of two different thumb splints: the Comfort Cool, a prefabricated neoprene splint and a custom made neoprene and thermoplastic thumb splint. These are two of the most commonly prescribed splints in local occupational therapy departments.
Eligibility Criteria
Inclusion Criteria
- physician diagnosis of CMC OA
- 45 years or older
- able to read and write in English
Exclusion Criteria
- previous thumb surgery
Data sourced from ClinicalTrials.gov (NCT00705146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.