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

NCT02266095 | Withdrawn

• 1 other identifier: UFJ 2013-136
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpometacarpal (CMC) Joint Arthritis

Keywords

Osteoarthritis; Thumb spica splint; Oval-8 splint; Tee-Pee splint

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain Score

  12 Weeks

Study Arms (3)

Oval-8 Splint

ACTIVE COMPARATOR

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

Tee Pee Splint

ACTIVE COMPARATOR

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

Forearm Based Splint

ACTIVE COMPARATOR

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

Interventions

Oval-8 Splint DEVICE

Splinting with Oval-8

Oval-8 Splint

Tee Pee Splint DEVICE

Splinting with Tee Pee

Tee Pee Splint

Forearm Based Splint DEVICE

Splinting with Forearm based

Forearm Based Splint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Carpometacarpal (CMC) osteoarthritis
• greater than or equal to 35 degrees of passive thumb interphalangeal (IP) joint hyperextension on physical exam

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health Orthopaedics - Jacksonville (Emerson)

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Capillary Malformations, Congenital, 1; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Marc B Kaye, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 16, 2014
• Study Start: January 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 4, 2016

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)