- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00438191
A Clinical Trial of Splinting for DeQuervain's Tenosynovitis
A Clinical Trial of Full Time vs. As Needed Splint Wear for DeQuervain's Tenosynovitis
Study Overview
Status
Conditions
Detailed Description
De Quervain's tenosynovitis (stenosing tenosynovitis of the first dorsal extensor compartment) is characterized by pain on the radial (thumb) side of the wrist and impairment of thumb and wrist function. Histological evaluation is consistent with a chronic rather than an acute tenosynovitis consistent with the often prolonged course of this disease.
Nonoperative treatments include modification of activities, splint immobilization, icing and anti-inflammatory medication, and corticosteroid injections. Long opponens splinting (or short arm thumb spica splinting; a splint that immobilizes the wrist and the thumb) is standard and well accepted. There is no consensus on the best protocol for use of the splint. Some authors advocate full time splinting for 4 - 6 weeks, with the rationale that tendonitis will resolve with strict rest. Other authors, perhaps aware of histological evidence that De quervain's is a chronic rather than acute inflammatory condition, feel that the splint serves merely to relieve symptoms and is best used as best suits each individual patient. To our knowledge, there are not data available regarding these disparate views.
The ultimate prognosis for recovery in the condition seems satisfying, regardless of the treatment, and spontaneous recovery is the rule. Psychological and personality factors, such as pain anxiety, catastrophizing, and depression are strongly related to upper extremity specific health status and may also influence recovery.
The primary goal of this study is to determine which protocol of splinting leads to better outcome in non-surgical treatment of DeQuervain's tenosynovitis. As a secondary goal and to generate hypotheses for later studies we would like to evaluate the influence of psychosocial factors on both objective (grip strength) and subjective (DASH questionnaire) measures of outcome.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patient (age 18 years or greater)
- Physician very confident about the diagnosis of DeQuervain's tenosynovitis.
Exclusion Criteria:
- Patients with previous history of surgical treatment for De Quervain's.
- Skin conditions making splint wear problematic.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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1
Subjects who wear the splint whenever the feel the need.
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2
Subjects who wear the splint whenever possible.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
Time Frame: 8 weeks
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The DASH questionnaire measures upper extremity disability on a scale from 0-100, where 0 is no disability and 100 is severe disability.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grip Strength
Time Frame: 8 weeks
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Grip strength is measured as a percentage of the non-affected or least affected side.
|
8 weeks
|
Treatment Satisfaction
Time Frame: 8 weeks
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Treatment satisfaction was measured on a scale from 0-10, where 0 is complete dissatisfaction and 10 is complete satisfaction
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8 weeks
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Pain Intensity
Time Frame: 8 weeks
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Pain intensity was measured using the Numeric Rating Scale, on a scale from 0-10, where 0 is no pain and 10 is the most pain.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005-P-002319
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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Clinical Trials on DeQuervain's Tenosynovitis
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Medical College of WisconsinTerminated
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Cerimon PharmaceuticalsPPDCompletedRotator Cuff Tendonitis | Bicipital Tendonitis | Subdeltoid Bursitis of the Shoulder | Subacromial Bursitis of the Shoulder | Medial Epicondylitis of the Elbow | Lateral Epicondylitis of the Elbow | DeQuervain's Tenosynovitis of the WristUnited States
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Cairo UniversityNot yet recruiting
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The University of Hong KongCompleted
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J&M ShulerVivex BiomedicalUnknownStenosing TenosynovitisUnited States
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Centre Hospitalier Universitaire VaudoisRecruitingTrigger Finger | Stenosing TenosynovitisSwitzerland
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St. Louis UniversityTerminatedBicep Tendinitis | Biceps; Tenosynovitis | Biceps Tendon DisorderUnited States
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University of California, DavisRecruitingDe Quervain TenosynovitisUnited States
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Hacettepe UniversityRecruitingTrigger Finger | Stenosing TenosynovitisTurkey
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National University of MalaysiaRecruitingTrigger Finger | Stenosing TenosynovitisMalaysia