De Quervain DiseaseNCT05692583
Correlation Between EPB Entrapment Test and Ultrasound Wrist Findings in Patients With deQuervain's Disease
An observational study of De Quervain Disease, run by Velammal Medical College Hospital and Research Institute at 1 site in India.
Trial summary
The goal of this observational study is to learn about the correlation between EPB entrapment test and ultrasound wrist findings in patients with deQuervain's disease The main questions it aims to answer are: if correlation exist between EPB entrapment test and ultrasound wrist findings in patients with deQuervain's… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- De Quervain Disease
- What is being tested?
- ultrasound examination of wrist
- How many people
- 39 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2020to 8 Jul 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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: all adults >18 years of age with positive Finkelsteins test are included
Who may be able to join
- Age >18
- Radial side wrist pain
- Finkelstein test positive
- Failure of non surgical treatment
Who cannot join
- Patients who underwent Previous surgical release
Trial locations and contacts
1 site in 1 country.
India1 site
Velammal medical college hospital and research institute
Madurai, Tamil Nadu, 625009
About this study
The goal of this observational study is to learn about the correlation between EPB entrapment test and ultrasound wrist findings in patients with deQuervain's disease The main questions it aims to answer are:
- if correlation exist between EPB entrapment test and ultrasound wrist findings in patients with deQuervain's disease ?
- if the the correlation aid in deciding management of patients with deQuervain's disease Participants will be subjected to
- EPB entrapment test
- ultrasound examination of wrist
- Conditions
- De Quervain Disease
- Being tested
- ultrasound examination of wrist
- Keywords
- de quervain's disease, anatomical variations, EPB entrapment test
- Medical subject headings
- De Quervain Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound examination of wristDiagnostic test
musculoskeletal ultrasound examination of affected wrist
What is being measured
The primary outcome is the main question the study is designed to answer.
EPB entrapment test
comparing the pain elicited during resisted thumb MCP joint abduction and resisted thumb MCP joint extension
Measured: 1 day
Ultrasound examination of wrist
musculoskeletal ultrasound of affected wrist is done for examining the anatomical variations of first extensor compartment
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Nov 2020
- Primary completion8 Jul 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for De Quervain DiseaseStudies of the same condition, open and under way.
- 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
- 39 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Velammal Medical College Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vijayaraja Elangovan, Velammal Medical College Hospital and Research Institute
- Investigators
- Srinivasan Rajappa, MS, DNB, Study director, Sri Ramachandra Institute of Higher Education and ResearchVijayaraja Elangovan, MS, Study chair, Velammal Medical College Hospital and Research InstituteGokul Kumar Jeganathan, MBBS, Principal investigator, Velammal medical college hospital and research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692583
- Sponsor's protocol ID
- VMCIEC/27/2022
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2023
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Finkelstein H. STENOSING TENDOVAGINITIS AT THE RADIAL STYLOID PROCESS. JBJS. 1930 Jul;12(3):509-40.
E E. Zur Pathogenese der Tendovaginitis stenosans. Bruns Beitrage Z Klin Chir. 1927;0:746-55.
GILES KW. Anatomical variations affecting the surgery of de Quervain's disease. J Bone Joint Surg Br. 1960 May;42-B:352-5. doi: 10.1302/0301-620X.42B2.352. No abstract available.
PubMed 13850049The extensor pollicis brevis entrapment test in the treatment of de Quervain's disease - Journal of Hand Surgery [Internet]. [cited 2022 Dec 15]. Available from: https://www.jhandsurg.org/article/S0363-5023(02)00033-3/fulltext
Lee KH, Kang CN, Lee BG, Jung WS, Kim DY, Lee CH. Ultrasonographic evaluation of the first extensor compartment of the wrist in de Quervain's disease. J Orthop Sci. 2014 Jan;19(1):49-54. doi: 10.1007/s00776-013-0481-3. Epub 2013 Oct 17.
PubMed 24132793
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between EPB Entrapment Test and Ultrasound Wrist Findings in Patients With deQuervain's Disease
- ClinicalTrials.gov ID
- NCT05692583
- Acronym / sponsor ID
- VMCIEC/27/2022
- Conditions
- De Quervain Disease
- Keywords
- de quervain's disease, anatomical variations, EPB entrapment test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Velammal Medical College Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the correlation between EPB entrapment test and ultrasound wrist findings in patients with deQuervain's disease The main questions it aims to answer are:
- if correlation exist between EPB entrapment test and ultrasound wrist findings in patients with deQuervain's disease ?
- if the the correlation aid in deciding management of patients with deQuervain's disease Participants will be subjected to
- EPB entrapment test
- ultrasound examination of wrist
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all adults >18 years of age with positive Finkelsteins test are included
Key inclusion criteria (4 listed)
- Age >18
- Radial side wrist pain
- Finkelstein test positive
- Failure of non surgical treatment
Key exclusion criteria (1 listed)
- Patients who underwent Previous surgical release
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound examination of wristmusculoskeletal ultrasound examination of affected wrist | Diagnostic test | – |
Primary outcome
EPB entrapment test
Time frame: 1 day
comparing the pain elicited during resisted thumb MCP joint abduction and resisted thumb MCP joint extension
Ultrasound examination of wrist
Time frame: 1 day
musculoskeletal ultrasound of affected wrist is done for examining the anatomical variations of first extensor compartment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- BackgroundFinkelstein H. STENOSING TENDOVAGINITIS AT THE RADIAL STYLOID PROCESS. JBJS. 1930 Jul;12(3):509-40.
- BackgroundE E. Zur Pathogenese der Tendovaginitis stenosans. Bruns Beitrage Z Klin Chir. 1927;0:746-55.
- Background: PubMed 13850049GILES KW. Anatomical variations affecting the surgery of de Quervain's disease. J Bone Joint Surg Br. 1960 May;42-B:352-5. doi: 10.1302/0301-620X.42B2.352. No abstract available.
- BackgroundThe extensor pollicis brevis entrapment test in the treatment of de Quervain's disease - Journal of Hand Surgery [Internet]. [cited 2022 Dec 15]. Available from: https://www.jhandsurg.org/article/S0363-5023(02)00033-3/fulltext
- Background: PubMed 24132793Lee KH, Kang CN, Lee BG, Jung WS, Kim DY, Lee CH. Ultrasonographic evaluation of the first extensor compartment of the wrist in de Quervain's disease. J Orthop Sci. 2014 Jan;19(1):49-54. doi: 10.1007/s00776-013-0481-3. Epub 2013 Oct 17.
- Individual participant dataSharing planned: No
Related trials for De Quervain Disease
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NAC-REPAIR for Post-surgical Pain
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RecruitingPhase 4
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De Quervain Tenosynovitis
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.
Srinivasan Rajappa, MS, DNB study director
Sri Ramachandra Institute of Higher Education and Research
Vijayaraja Elangovan, MS study chair
Velammal Medical College Hospital and Research Institute
Gokul Kumar Jeganathan, MBBS principal investigator
Velammal medical college hospital and research
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 De Quervain Disease, run by Velammal Medical College Hospital and Research Institute at 1 site in India.
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 4 inclusion and 1 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 Jan 2023. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
EPB entrapment test (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05692583, which also lists 5 linked publications.
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 Jan 2023.