CMC (Carpometacarpal) OA (Osteoarthritis) Thumb Splint Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Vancouver Foundation
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00705146
First received: June 23, 2008
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

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
Osteoarthritis, Carpometacarpal
Device: Comfort Cool thumb splint by North Coast Medical
Device: Custom made thermoplastic & neoprene splint
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Two Carpometacarpal Stabilizing Splints for People With Thumb Osteoarthritis

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The objectives of splinting the CMC joint include stabilizing the joint, reducing pain symptoms as well as enhancing performance of everyday activities. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: April 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Comfort Cool splint, to be worn for 4 weeks
Device: Comfort Cool thumb splint by North Coast Medical
Comfort Cool splint = Standard neoprene wrap-on thumb support
Active Comparator: 2
Custom made thermoplastic and neoprene thumb splint based on Pat McKee`s hybrid design
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dr's diagnosis of CMC OA
  • 45 years or older
  • able to read and write in English

Exclusion Criteria:

• previous thumb surgery

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705146

Contacts
Contact: Helia Sillem 250-755-7611 helia.sillem@viha.ca

Locations
Canada, British Columbia
Campbell River Hospital Recruiting
Campbell River, British Columbia, Canada, V9W 3V1
Contact: Helia Sillem    250-755-7611    helia.sillem@viha.ca   
Nanaimo Regional General Hospital Recruiting
Nanaimo, British Columbia, Canada, V9S 2B7
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   
Sponsors and Collaborators
University of British Columbia
Vancouver Foundation
Investigators
Principal Investigator: Catherine Backman, Ph.D University of British Columbia
Study Director: Peter Kirk, Ph.D University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00705146     History of Changes
Other Study ID Numbers: H07-03133
Study First Received: June 23, 2008
Last Updated: April 24, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
CMC osteoarthritis
Thumb splints
AUSCAN-HI 3.1
Grip and pinch strength

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014