Clinical trial NCT00438763: CMC Arthritis - Neoprene Vs. Thermoplast Short Opponens Splinting
Official title: Prospective Randomized Comparison: Neoprene Vs. Thermoplast Short Opponens Splinting. Outcomes After a Five-week to Sixteen-week Treatment Trial.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpometacarpal Thumb Arthritis
Keywords: CMC arthritis
splint treatment
patient satisfaction
DASH questionnaire
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2007-02-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the MGH Hand and Upper Extremity service.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: DASH questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: patient satisfaction
timeFrame: 6 months
measure: pinch strength
timeFrame: 6 months
measure: grip strength
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: David Ring, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.