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CompletedNCT00438763Updated Sep 27, 2013

CMC Arthritis - Neoprene Vs. Thermoplast Short Opponens Splinting

An observational study in Carpometacarpal Thumb Arthritis, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-27.

Sponsored by Massachusetts General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Carpometacarpal Thumb Arthritis

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Keywords

  • CMC arthritis
  • splint treatment
  • patient satisfaction
  • DASH questionnaire
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 120 is below the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients from the MGH Hand and Upper Extremity service.

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

Exclusion Criteria:

  • Patients with previous history of CMC Thumb Arthritis treated surgically
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)

Groups and cohorts

  • 1

    Subjects using the neoprene splint.

  • 2

    Subjects using the orthoplast splint.

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What researchers measure

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

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Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

References and documents

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. PubMed 23458785 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00438763
Lead sponsor
Massachusetts General Hospital
Responsible party
David C. Ring, MD (Principal Investigator; Director of Research, Hand Service, Massachusetts General Hospital) — Principal investigator
First posted
Feb 22, 2007
Start date
Dec 2005
Primary completion
Dec 2012
Completion
Feb 2013
Last update
Sep 27, 2013

Study contacts

David Ring, MD, PhD
principal investigator · Massachusetts General Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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