MedTrace Logo

CMC (Carpometacarpal) OA (Osteoarthritis) Thumb Splint Study

NCT00705146 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2014-12-11

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DEVICE

Comfort Cool thumb splint by North Coast Medical

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.

DEVICE

Custom made thermoplastic & neoprene splint

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.

Sponsors & Collaborators

  • Vancouver Foundation

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Catherine Backman, Ph.D · University of British Columbia

  • Peter Kirk, Ph.D · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00705146 on ClinicalTrials.gov