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NCT Number: NCT00438191

A Clinical Trial of Splinting for DeQuervain's Tenosynovitis

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.

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Key information

Conditions

DeQuervain's Tenosynovitis Behavior Personal Satisfaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Grip Strength

    Time frame: 8 weeks

    Grip strength is measured as a percentage of the non-affected or least affected side.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

A Clinical Trial of Full Time vs. As Needed Splint Wear for DeQuervain's Tenosynovitis

Important dates

Study start
2005
Primary completion
2015
Study completion
2015
First posted
Feb 22, 2007
Registry last updated
Jun 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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