CMC Arthritis - Neoprene Vs. Thermoplast Short Opponens Splinting

Carpometacarpal Thumb Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438763
• Other study ID #: 2005-P-002327
• Status: Completed
• Phase: N/A
• First received: February 20, 2007
• Last updated: September 25, 2013
• Start date: December 2005
• Est. completion date: February 2013

Study information

• Verified date: September 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Carpometacarpal Thumb Arthritis

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DASH questionnaire		6 months	No
Secondary	patient satisfaction		6 months	No
Secondary	pinch strength		6 months	No
Secondary	grip strength		6 months	No