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Completed

NCT Number: NCT00438763

CMC Arthritis - Neoprene Vs. Thermoplast Short Opponens Splinting

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. DASH questionnaire

    Time frame: 6 months

Secondary outcomes

  1. patient satisfaction

    Time frame: 6 months

  2. pinch strength

    Time frame: 6 months

  3. grip strength

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2012
Study completion
2013
First posted
Feb 22, 2007
Registry last updated
Sep 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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