CMC Arthritis - Neoprene Vs. Thermoplast Short Opponens Splinting

Prospective Randomized Comparison: Neoprene Vs. Thermoplast Short Opponens Splinting. Outcomes After a Five-week to Sixteen-week Treatment Trial.

Carpometacarpal Thumb Arthritis is a disease caused by different factors and attacks mainly woman older than 50 years. The signs and symptoms consist in pain, swelling, joint instability, deformity and loss of motion. Some evidence has shown that splinting of the thumb may be of benefit. There are two methods of splinting: The first is Standard Neoprene wrap-on thumb support (in which the finger is kept in the same position with in a standard Neoprene thumb splint). The second is Thermoplast Short Opponens splint (This splint is custom-made and the thumb is use as a template to design the splint). The purpose of this study is to test and evaluate these two protocols of splinting and assess which one helps or works better in patients with thumb arthritis.

Study Overview

• Status: Completed
• Conditions: Carpometacarpal Thumb Arthritis

Detailed Description

Osteoarthritis of the thumb carpometacarpal joint is a common condition that affects approximately 16% to 25% of postmenopausal woman and causes pain, swelling, instability, deformity and loss of motion. This condition has been staged in 4 periods according to the degree of severity. Mild stages or stages 1 and 2 are usually treated conservatively by stabilization of the joint, which can be aggressively achieved by surgical ligament reconstruction or conservatively with thumb splints. Splinting is a typical treatment for osteoarthritis of the thumb with the goals of managing pain, stabilizing the CMC joint, and improving overall thumb function. There are limited studies showing the effectiveness of splinting for this condition indicating they are successful in decreasing pain and improving function in activities of daily living as well as radiographically improving joint stability. What is less clear is, once patients leave the clinic setting, how compliant they are with their splinting regimen. Patients with chronic illnesses tend to have compliance issues when it comes to their care. Also, there are limited studies comparing different modalities of splinting. A recent study compared custom-made short opponens thermoplastic splint with the metacarpo-phalangeal (MP) joint free to a pre-fabricated short neoprene splint. They found that patients preferred the neoprene splint but both splints provided some degree of pain relief, reduction of subluxation of the MP joint and improvement in function. Our purpose is to objectively quantify the various benefits of splinting for patients with thumb arthritis using the DASH score and assess if there is a difference between the pre-fabricated neoprene splint and the custom-made short opponens thermoplastic splint with the MP included.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from the MGH Hand and Upper Extremity service.

Description

Inclusion Criteria:

• Patients aged 18 or older.
• Males and females diagnosed using clinical criteria as having CMC Thumb Arthritis
• Radiological diagnosis is not necessary

Exclusion Criteria:

- Patients with previous history of CMC Thumb Arthritis treated surgically

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; Subjects using the neoprene splint.
2; Subjects using the orthoplast splint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
DASH questionnaire	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
patient satisfaction	6 months
pinch strength	6 months
grip strength	6 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Publications and helpful links

General Publications

• Becker SJ, Bot AG, Curley SE, Jupiter JB, Ring D. A prospective randomized comparison of neoprene vs thermoplast hand-based thumb spica splinting for trapeziometacarpal arthrosis. Osteoarthritis Cartilage. 2013 May;21(5):668-75. doi: 10.1016/j.joca.2013.02.006. Epub 2013 Feb 28.

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: February 20, 2007
• First Submitted That Met QC Criteria: February 20, 2007
• First Posted (Estimate): February 22, 2007

Study Record Updates

• Last Update Posted (Estimate): September 27, 2013
• Last Update Submitted That Met QC Criteria: September 25, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: patient satisfaction; DASH questionnaire; CMC arthritis; splint treatment
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: 2005-P-002327