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Sponsors and Collaborators: |
University of British Columbia Vancouver Foundation |
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Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00705146 |
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.
Condition | Intervention | Phase |
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Osteoarthritis, Carpometacarpal |
Device: Comfort Cool thumb splint by North Coast Medical Device: Custom made thermoplastic & neoprene splint |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Comparison of Two Carpometacarpal Stabilizing Splints for People With Thumb Osteoarthritis |
Estimated Enrollment: | 48 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Comfort Cool splint, to be worn for 4 weeks
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Device: Comfort Cool thumb splint by North Coast Medical
Comfort Cool splint = Standard neoprene wrap-on thumb support
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2: Active Comparator
Custom made thermoplastic and neoprene thumb splint based on Pat McKee`s hybrid design
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Device: Custom made thermoplastic & neoprene splint
Custom made thermoplastic and neoprene thumb splint based on Pat McKee`s hybrid design, to be worn for 4 weeks.
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Thumb (CMC) osteoarthritis is treated conservatively with splinting. The objectives of splinting the CMC joint include stabilizing the joint, reducing pain symptoms as well as enhancing performance of everyday activities. There is limited evidence to support the effectiveness of splinting in reducing pain and very little evidence to support the effectiveness of thumb splints to enhance function.
This CMC splint comparison study is a cross-over community based study of the effect of two different types of CMC stabilizing splints on patients with thumb OA. The objectives include measuring clients' OA symptoms and function using the Australian Canadian Osteoarthritis Hand Index (AUSCAN-HI 3.1), grip strength, pinch strength and client's personal splint preference on 4 separate occasions in order to compare the two thumb splints. The two splints differ in material and design. One splint is softer and incorporates more of the hand. The evidence gathered will support the effectiveness of specific splint design. It will also provide best practice guidelines for splint selection in clients with CMC OA.
We are using a one group own control cross-over design where outcome measures will be taken at week 1, week 4, week 5 and week 9. Each client will wear both splints for a 4 week period separated by a 1 week wash out period.
Procedure:
First appointment: At the initial visit the client will be randomly assigned to splint order. The client will complete the AUSCAN-HI 3.1, and a grip and pinch strength measurement. The first CMC stabilizing splint will be fabricated and fitted as per normal splinting treatment for clients with CMC OA. The client will be instructed how to wear and care for their splint. General instructions will include wearing the splint for symptomatic use as well as heavy activities.
Second visit: The second visit will take place 4 weeks after the first unless the client needs to come in earlier for a splint adjustment. At this time the AUSCAN-HI 3.1 will be administered again. Grip and pinch strength will also be re-measured.
Third visit: After a one week wash-out period where the client does not wear any splint, they will attend the OT Outpatient department and complete the AUSCAN-HI 3.1, perform a grip and pinch strength measurement. They will be provided with the second CMC stabilizing splint and instructed in a wearing regime and the care of it.
Fourth visit: This will take place at approximately 9 weeks, 4 weeks after wearing the second splint. The AUSCAN-HI 3.1 will be completed for the last time as well as a grip and pinch strength measurement. The client will also be asked their personal splint preference at this time.
Data will be collected and input into the computer.
Note: The procedures for grip and pinch strength measurement will follow the guidelines set out in the ASHT Clinical Assessment Recommendations.
Data Analysis: Data will be analyzed using ANOVA, to determine if there is a significant difference between the 2 splints for OA pain, function, grip strength and personal preference.
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
• previous thumb surgery
Contact: Helia Sillem | 250-755-7611 | helia.sillem@viha.ca |
Canada, British Columbia | |
Nanaimo Regional General Hospital | Recruiting |
Nanaimo, British Columbia, Canada, V9S 2B7 | |
Contact: Helia Sillem 250-755-7611 helia.sillem@viha.ca | |
Campbell River Hospital | Recruiting |
Campbell River, British Columbia, Canada, V9W 3V1 | |
Contact: Helia Sillem 250-755-7611 helia.sillem@viha.ca | |
Victoria Island Hand Clinic | Recruiting |
Victoria, British Columbia, Canada, V8R 4R2 | |
Contact: Helia Sillem 250-755-7611 helia.sillem@viha.ca |
Principal Investigator: | Catherine Backman, Ph.D | University of British Columbia |
Study Director: | Peter Kirk, Ph.D | University of British Columbia |
Responsible Party: | University of British Columbia ( Dr. Catherine Backman ) |
Study ID Numbers: | H07-03133 |
Study First Received: | June 23, 2008 |
Last Updated: | June 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00705146 |
Health Authority: | Canada: Health Canada |
CMC osteoarthritis Thumb splints AUSCAN-HI 3.1 Grip and pinch strength |
Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Influenza, Human Rheumatic Diseases |