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Trial record 1 of 140 for:    OVAL
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Oval-8 Splinting Versus Standardized Treatment With Tee Pee or Forearm Based Thumb Spica Splinting (Oval-8)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02266095
Recruitment Status : Withdrawn (Study closed prior to enrolling patients)
First Posted : October 16, 2014
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Carpometacarpal (CMC) Joint Arthritis Device: Oval-8 Splint Device: Tee Pee Splint Device: Forearm Based Splint Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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
Study Start Date : January 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.

Device: Oval-8 Splint
Splinting with Oval-8

Active Comparator: 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.

Device: Tee Pee Splint
Splinting with Tee Pee

Active Comparator: 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.

Device: Forearm Based Splint
Splinting with Forearm based




Primary Outcome Measures :
  1. DASH Score [ Time Frame: 12 Weeks ]

    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.



Secondary Outcome Measures :
  1. Pain Score [ Time Frame: 12 Weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266095


Locations
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United States, Florida
UF Health Orthopaedics - Jacksonville (Emerson)
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Marc B Kaye, M.D. University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02266095    
Other Study ID Numbers: UFJ 2013-136
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share participant data as no patients were enrolled in the study.
Keywords provided by University of Florida:
Osteoarthritis
Thumb spica splint
Oval-8 splint
Tee-Pee splint
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases