Clinical trial NCT00438191: A Clinical Trial of Splinting for DeQuervain's Tenosynovitis
Official title: A Clinical Trial of Full Time vs. As Needed Splint Wear for DeQuervain's Tenosynovitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: DeQuervain's Tenosynovitis
Keywords: DeQuervain's tenosynovitis
splinting
grip strength
satisfaction
DASH questionnaire
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2007-02-22
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the MGH Hand and Upper Extremity Service.

Brief summary: DeQuervain's tenosynovitis is characterized by pain on the pain on the radial (thumb) side of the wrist problems with thumb function. At this point, the standard care is to change daily activities, use a thumb brace, and the possible use of painkillers. There is a difference in opinion among physical therapists about how to use the splint in the treatment of DeQuervain tenosynovitis. Some physicians tell patients to wear the brace at all times while other therapists encourage patients to exercise and use the brace as needed. Both approaches to using the splint are accepted as standard. The purpose of this study is to test and evaluate these two ways of splinting and assess which one is better for patients with DeQuervain tenosynovitis.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
timeFrame: 8 weeks
Secondary outcomes:
measure: Grip Strength
timeFrame: 8 weeks
measure: Treatment Satisfaction
timeFrame: 8 weeks
measure: Pain Intensity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: David Ring, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: