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CMC Arthritis - Neoprene Vs. Thermoplast Short Opponens Splinting

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ClinicalTrials.gov Identifier: NCT00438763
Recruitment Status : Completed
First Posted : February 22, 2007
Last Update Posted : September 27, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Carpometacarpal 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.

Study Design

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Randomized Comparison: Neoprene Vs. Thermoplast Short Opponens Splinting. Outcomes After a Five-week to Sixteen-week Treatment Trial.
Study Start Date : December 2005
Primary Completion Date : December 2012
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
U.S. FDA Resources

Groups and Cohorts

Subjects using the neoprene splint.
Subjects using the orthoplast splint.

Outcome Measures

Primary Outcome Measures :
  1. DASH questionnaire [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. patient satisfaction [ Time Frame: 6 months ]
  2. pinch strength [ Time Frame: 6 months ]
  3. grip strength [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

- Patients with previous history of CMC Thumb Arthritis treated surgically

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438763

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: David Ring, MD, PhD Massachusetts General Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David C. Ring, MD, Principal Investigator; Director of Research, Hand Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438763     History of Changes
Other Study ID Numbers: 2005-P-002327
First Posted: February 22, 2007    Key Record Dates
Last Update Posted: September 27, 2013
Last Verified: September 2013

Keywords provided by David C. Ring, MD, Massachusetts General Hospital:
CMC arthritis
splint treatment
patient satisfaction
DASH questionnaire

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases