Oval-8 Splinting Versus Standardized Treatment With Tee Pee or Forearm Based Thumb Spica Splinting (Oval-8)

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.

Study Overview

• Status: Withdrawn
• Conditions: Carpometacarpal (CMC) Joint Arthritis
• Intervention / Treatment: Device: Oval-8 Splint; Device: Tee Pee Splint; Device: Forearm Based Splint

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32207
      • UF Health Orthopaedics - Jacksonville (Emerson)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Marc B Kaye, M.D., University of Florida

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ACTUAL): August 1, 2016
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: October 10, 2014
• First Submitted That Met QC Criteria: October 10, 2014
• First Posted (ESTIMATE): October 16, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): November 4, 2016
• Last Update Submitted That Met QC Criteria: November 2, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Osteoarthritis; Thumb spica splint; Oval-8 splint; Tee-Pee splint
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: UFJ 2013-136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to share participant data as no patients were enrolled in the study.