Oval-8 Splinting Versus Standardized Treatment With Tee Pee or Forearm Based Thumb Spica Splinting
NCT ID: NCT02266095
Last Updated: 2016-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2016-01-31
2016-08-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Oval-8 Splint
Patients will be asked to wear their assigned splint 24 hours per day with removal for hygiene care. Follow-up appointments will occur at week 4 and 12. Each visit will include a clinical examination, splint assessment for continued appropriate fit and evaluation of skin for irritation or breakdown.
Standard non-operative therapy includes activity modification, therapy, NSAIDS, splinting (thumb spica or Tee-Pee). Oval-8 splints are not commonly used for treatment of thumb CMC arthritis.
Procedures will be undertaken to minimize patient discomfort. Participants will be instructed to continue with range of motion exercises to 2-5th digits and elbow to try to avoid stiffness.
Oval-8 Splint
Splinting with Oval-8
Tee Pee Splint
Patients will be asked to wear their assigned splint 24 hours per day with removal for hygiene care. Follow-up appointments will occur at week 4 and 12. Each visit will include a clinical examination, splint assessment for continued appropriate fit and evaluation of skin for irritation or breakdown.
Standard non-operative therapy includes activity modification, therapy, NSAIDS, splinting (thumb spica or Tee-Pee).
Procedures will be undertaken to minimize patient discomfort. Participants will be instructed to continue with range of motion exercises to 2-5th digits and elbow to try to avoid stiffness.
Tee Pee Splint
Splinting with Tee Pee
Forearm Based Splint
Patients will be asked to wear their assigned splint 24 hours per day with removal for hygiene care. Follow-up appointments will occur at week 4 and 12. Each visit will include a clinical examination, splint assessment for continued appropriate fit and evaluation of skin for irritation or breakdown.
Standard non-operative therapy includes activity modification, therapy, NSAIDS, splinting (thumb spica or Tee-Pee).
Procedures will be undertaken to minimize patient discomfort. Participants will be instructed to continue with range of motion exercises to 2-5th digits and elbow to try to avoid stiffness.
Forearm Based Splint
Splinting with Forearm based
Interventions
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Oval-8 Splint
Splinting with Oval-8
Tee Pee Splint
Splinting with Tee Pee
Forearm Based Splint
Splinting with Forearm based
Eligibility Criteria
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Inclusion Criteria
* greater than or equal to 35 degrees of passive thumb interphalangeal (IP) joint hyperextension on physical exam
Exclusion Criteria
* Prior surgical treatment for thumb carpometacarpal (CMC) osteoarthritis.
* Patients with diagnosis of an autoimmune arthritis and post traumatic arthritis
18 Years
ALL
Yes
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Marc B Kaye, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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UF Health Orthopaedics - Jacksonville (Emerson)
Jacksonville, Florida, United States
Countries
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Other Identifiers
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UFJ 2013-136
Identifier Type: -
Identifier Source: org_study_id