CMC Arthritis - Neoprene Vs. Thermoplast Short Opponens Splinting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00438763
First received: February 20, 2007
Last updated: September 25, 2013
Last verified: September 2013

February 20, 2007
September 25, 2013
December 2005
December 2012   (final data collection date for primary outcome measure)
DASH questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
DASH questionnaire
Complete list of historical versions of study NCT00438763 on ClinicalTrials.gov Archive Site
  • patient satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • pinch strength [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • grip strength [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • patient satisfaction
  • pinch strength
  • grip strength
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients from the MGH Hand and Upper Extremity service.

Carpometacarpal Thumb Arthritis
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  • 1
    Subjects using the neoprene splint.
  • 2
    Subjects using the orthoplast splint.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
February 2013
December 2012   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00438763
2005-P-002327
Not Provided
David C. Ring, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: David Ring, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP