Carpometacarpal (CMC) Joint Arthritis Clinical Trial
— Oval-8Official title:
Pilot Study of a Novel Splint Treatment for Thumb CMC Joint Arthritis: a Comparison of Oval-8 Splinting Versus Standardized Treatment With Tee Pee or Forearm Based Thumb Spica Splinting
| Verified date | December 2015 |
| Source | University of Florida |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The oval-8 splint has been developed for many uses in finger pathology and trauma. It has
not, however, been used to treat thumb carpometacarpal (CMC) joint arthritis. When treating
thumb CMC joint osteoarthritis, splinting is a very widely used and supported treatment
option for non-operative management. Many studies have been performed showing that thumb
spica splinting in abduction with either a hand based or forearm based splint improves pain.
This study aims to compare the effects of a novel splinting approach with oval-8 splints for
the hyperextended thumb interphalangeal (IP) joint vs. standardized treatment with Tee Pee
splinting (hand based thumb spica) or forearm thumb spica splinting on pain and function of
patients with thumb CMC joint arthritis.
This is a pilot study will address the following hypothesis: Splinting of the hyperextended
thumb IP joint with oval-8 splints will lead to increased DASH scores and decreased pain on
physical exam compared to splinting with thumb spica splints in patients with thumb CMC
arthritis.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | August 2016 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Carpometacarpal (CMC) osteoarthritis - greater than or equal to 35 degrees of passive thumb interphalangeal (IP) joint hyperextension on physical exam Exclusion Criteria: - History of hand surgery to affected hand - Prior surgical treatment for thumb carpometacarpal (CMC) osteoarthritis. - Patients with diagnosis of an autoimmune arthritis and post traumatic arthritis |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United States | UF Health Orthopaedics - Jacksonville (Emerson) | Jacksonville | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of Florida |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | DASH Score | The DASH is scored in two components. The disability/symptom questions (30 items scored 1-5) includes the following scoring categories: no difficulty - unable, not at all - extremely, not limited at all - unable, none - extreme, no difficulty - so much difficulty that I can't sleep, and strongly disagree - strongly agree. At least 27 out of 30 items must be completed for a score to be calculated. The assigned values for all completed responses are summed and averaged, producing a score out of five. The second section high performance sport/music or work section. This section of 4 items scored 1-5 includes no difficulty - unable, scoring category. The scoring calculations are the same for this area. |
12 Weeks | No |
| Secondary | Pain Score | The general pain scale ranges 0 - 10, with 0 being no pain and 10 being worst possible pain. Pinch pain and Grip pain will the measured with and without the splint. The ranges are the same for all pain scales. | 12 Weeks | No |