Oval-8 Splinting Versus Standardized Treatment With Tee Pee or Forearm Based Thumb Spica Splinting
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2016 |
| End Date: | December 2017 |
| Contact: | Marc B Kaye, M.D. |
| Email: | marc.kaye@jax.ufl.edu |
| Phone: | (904) 244-5946 |
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
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.
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.
After informed consent is obtained and the patient has met all of the inclusion criteria and
non of the exclusion criteria, the patient will be assigned a study ID number. The patient
will be randomized with a ratio of 1:1:1 to a splint treatment with either a forearm thumb
spica splint, Tee-Pee splint or oval- 8 splint at the time of initial visit to Orthopaedic
Hand clinic (week 1 visit). The patient will be fitted and provided with the appropriate
splint by Orthopaedic physician.
Baseline radiographs (3 views anterior-posterior, lateral and oblique) and data points will
be gathered from initial clinic history and physical, as performed per normal clinical
protocol: arthritis grade, hand involved, dominant hand, interphalangeal (IP) extension, MCP
extension, pinch strength, grip strength, pain scale, location of pain, DASH scores,
analgesic use, and work/hobby activity. Additionally, demographic data including age, gender
and race/ethnicity will be gathered and patient will be asked to repeat pinch and grip tests
with study splint applied and asked to repeat assessment of pain scale.
non of the exclusion criteria, the patient will be assigned a study ID number. The patient
will be randomized with a ratio of 1:1:1 to a splint treatment with either a forearm thumb
spica splint, Tee-Pee splint or oval- 8 splint at the time of initial visit to Orthopaedic
Hand clinic (week 1 visit). The patient will be fitted and provided with the appropriate
splint by Orthopaedic physician.
Baseline radiographs (3 views anterior-posterior, lateral and oblique) and data points will
be gathered from initial clinic history and physical, as performed per normal clinical
protocol: arthritis grade, hand involved, dominant hand, interphalangeal (IP) extension, MCP
extension, pinch strength, grip strength, pain scale, location of pain, DASH scores,
analgesic use, and work/hobby activity. Additionally, demographic data including age, gender
and race/ethnicity will be gathered and patient will be asked to repeat pinch and grip tests
with study splint applied and asked to repeat assessment of pain scale.
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
We found this trial at
1
site
Jacksonville, Florida 32207
Principal Investigator: Marc B Kaye, M.D.
Phone: 904-244-5946
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