DeQuervain's TenosynovitisNCT00438191
A Clinical Trial of Splinting for DeQuervain's Tenosynovitis
An observational study of DeQuervain's Tenosynovitis, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DeQuervain's Tenosynovitis
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the MGH Hand and Upper Extremity Service.
Who may be able to join
- Adult patient (age 18 years or greater)
- Physician very confident about the diagnosis of DeQuervain's tenosynovitis.
Who cannot join
- Patients with previous history of surgical treatment for De Quervain's.
- Skin conditions making splint wear problematic.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Clinical Trial of Full Time vs. As Needed Splint Wear 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.
Read the 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.
- Conditions
- DeQuervain's Tenosynovitis
- Keywords
- DeQuervain's tenosynovitis, splinting, grip strength, satisfaction, DASH questionnaire
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subjects who wear the splint whenever the feel the need. | |
| 2 | Subjects who wear the splint whenever possible. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (3)
Grip Strength
Grip strength is measured as a percentage of the non-affected or least affected side.
Measured: 8 weeks
Treatment Satisfaction
Treatment satisfaction was measured on a scale from 0-10, where 0 is complete dissatisfaction and 10 is complete satisfaction
Measured: 8 weeks
Pain Intensity
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startDec 2005
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DeQuervain's TenosynovitisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David C. Ring, MD, Massachusetts General Hospital
- Investigators
- David Ring, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438191
- Sponsor's protocol ID
- 2005-P-002319
- Status last verified
- Apr 2017
- First submitted
- 20 Feb 2007
- Last updated
- 20 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Full Time vs. As Needed Splint Wear for DeQuervain's Tenosynovitis
- ClinicalTrials.gov ID
- NCT00438191
- Acronym / sponsor ID
- 2005-P-002319
- Conditions
- DeQuervain's Tenosynovitis
- Keywords
- DeQuervain's tenosynovitis, splinting, grip strength, satisfaction, DASH questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Feb 2007 (estimated)
- Results
- Posted 20 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subjects who wear the splint whenever the feel the need. |
| 2 | – | –Subjects who wear the splint whenever possible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the MGH Hand and Upper Extremity Service.
Key inclusion criteria (2 listed)
- Adult patient (age 18 years or greater)
- Physician very confident about the diagnosis of DeQuervain's tenosynovitis.
Key exclusion criteria (2 listed)
- Patients with previous history of surgical treatment for De Quervain's.
- Skin conditions making splint wear problematic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Grip Strength
Time frame: 8 weeks
Treatment Satisfaction
Time frame: 8 weeks
Pain Intensity
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for DeQuervain's Tenosynovitis
Not yet recruitingObservational study
Early Functional Response as a Predictor of Clinical Outcomes in Hand Rehabilitation: A Prospective Feasibility Study Using a Digital Monitoring System
Hand, Hand Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ring, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DeQuervain's Tenosynovitis, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.