CMC (Carpometacarpal) OA (Osteoarthritis) Thumb Splint Study
NCT ID: NCT00705146
Last Updated: 2014-12-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2008-04-30
2009-06-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Comfort Cool Splint
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.
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.
Hybrid Custom-made 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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 45 years or older
* able to read and write in English
Exclusion Criteria
45 Years
ALL
No
Sponsors
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Vancouver Foundation
OTHER
University of British Columbia
OTHER
Responsible Party
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Principal Investigators
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Catherine Backman, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Peter Kirk, Ph.D
Role: STUDY_DIRECTOR
University of British Columbia
Locations
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Campbell River Hospital
Campbell River, British Columbia, Canada
Nanaimo Regional General Hospital
Nanaimo, British Columbia, Canada
Victoria Island Hand Clinic
Victoria, British Columbia, Canada
Countries
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References
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Sillem H, Backman CL, Miller WC, Li LC. Comparison of two carpometacarpal stabilizing splints for individuals with thumb osteoarthritis. J Hand Ther. 2011 Jul-Sep;24(3):216-25; quiz 126; discussion 227-30. doi: 10.1016/j.jht.2010.12.004. Epub 2011 Mar 21.
Other Identifiers
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H07-03133
Identifier Type: -
Identifier Source: org_study_id