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A Clinical Trial of Splinting for DeQuervain's Tenosynovitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00438191
First Posted: February 22, 2007
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
  Purpose
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.

Condition
DeQuervain's Tenosynovitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Trial of Full Time vs. As Needed Splint Wear for DeQuervain's Tenosynovitis

Further study details as provided by David C. Ring, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 83
Study Start Date: December 2005
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Subjects who wear the splint whenever the feel the need.
2
Subjects who wear the splint whenever possible.

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

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.
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.
  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): NCT00438191


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

Responsible Party: David C. Ring, MD, Principal Investigator; Director of Research, Hand Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438191     History of Changes
Other Study ID Numbers: 2005-P-002319
First Submitted: February 20, 2007
First Posted: February 22, 2007
Results First Submitted: February 2, 2017
Results First Posted: June 20, 2017
Last Update Posted: June 20, 2017
Last Verified: April 2017

Keywords provided by David C. Ring, MD, Massachusetts General Hospital:
DeQuervain's tenosynovitis
splinting
grip strength
satisfaction
DASH questionnaire

Additional relevant MeSH terms:
Tenosynovitis
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases