CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
Comfort Cool thumb splint by North Coast Medical +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00705146
NCT00705146Phase 2Completed
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Comparison of Two Carpometacarpal Stabilizing Splints for People With Thumb Osteoarthritis

University of British Columbia·interventional·Posted Jun 25, 2008·Updated Dec 11, 2014

In Brief

A Phase 2 clinical trial evaluating Comfort Cool thumb splint by North Coast Medical and Custom made thermoplastic & neoprene splint for Osteoarthritis. Completed, enrolled 56 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesCanada
CollaboratorsVancouver Foundation

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 25, 2008
Enrollment StartApr 1, 2008
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.0 years ago

Interventions

Comfort Cool thumb splint by North Coast Medicaldevice

Comfort Cool(TM) splint, a prefabricated neoprene splint, fit according to the participant's size (S, M, M+, L). Participants instructed to wear the splint when symptomatic, during manual tasks, and at night if desired. Used for 4 weeks. Treating therapists did not provide exercises or joint protection education until the final outcome measurement session at 9 weeks.

Custom made thermoplastic & neoprene splintdevice

The Hybrid splint was based on Pat McKee's custom-made splint design, fabricated from neoprene and 1.6 mm Rolyan Aquaplast Watercolors (Bollingbrook, IL). Participants were instructed to wear the splint when symptomatic, during manual tasks, and at night if desired. Splint was worn for 4 weeks. Treating therapists did not provide exercises or joint protection education until the final outcome measurement session at 9 weeks.