A Clinical Trial of Splinting for DeQuervain's Tenosynovitis
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|ClinicalTrials.gov Identifier: NCT00438191|
Recruitment Status : Completed
First Posted : February 22, 2007
Results First Posted : June 20, 2017
Last Update Posted : June 20, 2017
|Condition or disease|
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 :||Observational|
|Actual Enrollment :||83 participants|
|Official Title:||A Clinical Trial of Full Time vs. As Needed Splint Wear for DeQuervain's Tenosynovitis|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Subjects who wear the splint whenever the feel the need.
Subjects who wear the splint whenever possible.
- Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire [ Time Frame: 8 weeks ]The DASH questionnaire measures upper extremity disability on a scale from 0-100, where 0 is no disability and 100 is severe disability.
- Grip Strength [ Time Frame: 8 weeks ]Grip strength is measured as a percentage of the non-affected or least affected side.
- Treatment Satisfaction [ Time Frame: 8 weeks ]Treatment satisfaction was measured on a scale from 0-10, where 0 is complete dissatisfaction and 10 is complete satisfaction
- Pain Intensity [ Time Frame: 8 weeks ]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.
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): NCT00438191
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||David Ring, MD, PhD||Massachusetts General Hospital|