CMC (Carpometacarpal) OA (Osteoarthritis) Thumb Splint Study

NCT00705146 | Completed Phase 2 Results

• 1 other identifier: H07-03133
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

Brief 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

Osteoarthritis

Keywords

Osteoarthritis, carpometacarpal joint; Thumb splints; AUSCAN-HI 3.1; Grip and pinch strength

Outcome Measures

Primary Outcomes (1)

• Hand Function

  Hand Function was measured with the Australian Canadian Osteoarthritis Hand Index 3.1 (AUSCAN). The AUSCAN is a self-report tool with 15 questions in 3 subscales: pain, function, joint stiffness, and uses an 11-point (0-10) numerical rating scale. The AUSCAN function subscale has 9 items regarding level of difficulty in performing daily tasks such as opening a jar, turning a doorknob, wringing out a washcloth. Possible scores range from 0 to 90. Mean change scores are reported (baseline compared to 4 weeks splint use). Higher scores indicate worse function.

  4 weeks

Secondary Outcomes (1)

• Pain

  4 weeks

Study Arms (2)

Comfort Cool Splint

ACTIVE COMPARATOR

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.

Device: Comfort Cool thumb splint by North Coast Medical

Hybrid Custom-made splint

ACTIVE COMPARATOR

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.

Device: Custom made thermoplastic & neoprene splint

Interventions

Comfort Cool thumb splint by North Coast Medical DEVICE

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.

Comfort Cool Splint

Custom made thermoplastic & neoprene splint DEVICE

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.

Hybrid Custom-made splint

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• physician diagnosis of CMC OA
• years or older
• able to read and write in English

You may not qualify if:

• previous thumb surgery

Sponsors & Collaborators

• University of British Columbia: lead
• Vancouver Foundation: collaborator

Study Sites (3)

Campbell River Hospital

Campbell River, British Columbia, V9W 3V1, Canada

Location

Nanaimo Regional General Hospital

Nanaimo, British Columbia, V9S 2B7, Canada

Location

Victoria Island Hand Clinic

Victoria, British Columbia, V8R 4R2, Canada

Location

Related Publications (1)

• 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.

  PMID: 21420278 RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

The main limitation of this cross-over trial was that the therapists who collected the data were not blinded to the splinting intervention, as they were required to fabricate and fit each splint.

Results Point of Contact

• Title: Helia Sillem MScOT
• Organization: VIHA

helia.sillem@viha.ca

2507557611

Study Officials

• Catherine Backman, Ph.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Peter Kirk, Ph.D

  University of British Columbia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 25, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 11, 2014
• Results First Posted: December 11, 2014

Record last verified: 2014-12

Locations

CA (3)