NCT00438191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

June 20, 2017

Completed
Last Updated

June 20, 2017

Status Verified

April 1, 2017

Enrollment Period

10 years

First QC Date

February 20, 2007

Results QC Date

February 2, 2017

Last Update Submit

April 6, 2017

Conditions

Keywords

DeQuervain's tenosynovitissplintinggrip strengthsatisfactionDASH questionnaire

Outcome Measures

Primary Outcomes (1)

  • Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire

    The DASH questionnaire measures upper extremity disability on a scale from 0-100, where 0 is no disability and 100 is severe disability.

    8 weeks

Secondary Outcomes (3)

  • Grip Strength

    8 weeks

  • Treatment Satisfaction

    8 weeks

  • Pain Intensity

    8 weeks

Study Arms (2)

1

Subjects who wear the splint whenever the feel the need.

2

Subjects who wear the splint whenever possible.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from the MGH Hand and Upper Extremity Service.

You may qualify if:

  • Adult patient (age 18 years or greater)
  • Physician very confident about the diagnosis of DeQuervain's tenosynovitis.

You may not qualify if:

  • Patients with previous history of surgical treatment for De Quervain's.
  • Skin conditions making splint wear problematic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Taylor Pong
Organization
Massachusetts General Hospital

Study Officials

  • David Ring, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; Director of Research, Hand Service

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 22, 2007

Study Start

December 1, 2005

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 20, 2017

Results First Posted

June 20, 2017

Record last verified: 2017-04

Locations