- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06980779
- Original Trial
The Correlation of Clinical and Ultrasonographic Findings in Dorsoradial Wrist Pain Patients: Cross Sectional Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the assessment of the first carpometacarpal (CMC) joint, the following ultrasonographic parameters will be evaluated: synovitis, presence of osteophytes, joint surface irregularity, and Doppler signal activity. Additionally, conventional hand radiographs of all participants will be reviewed to support the imaging findings.
For the evaluation of De Quervain's tenosynovitis, tendon sheath thickness, tendon cross-sectional area, and intratendinous Doppler activity will be measured. At the anatomical intersection zones of the first dorsal compartment, the presence of peritendinous fluid and associated Doppler activity will also be assessed to identify potential sites of friction or inflammation.
Assessment of the superficial radial nerve will include measurement of its cross-sectional area. A cross-sectional area exceeding one square millimeter will be considered indicative of possible neuropathy.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ataşehir
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Istanbul, Ataşehir, Turkey, 34752
- University of Health Sciences, FSM Training and Research Hospital, Istanbul
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- pain in dorsoradial wrist
Exclusion Criteria:
- known rheumatological disease
- history of forearm, wrist, hand fracture
- history of forearm, wrist, hand operation
- mental retardation
- history of major trauma in forearm, wrist and hand
- fibromyalgia
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Odds Ratio of First Extensor Compartment Tendon Sheath Thickness Associated with De Quervain Disease
Time Frame: At the time of enrollment
|
To quantify the association between increased tendon sheath thickness and clinical diagnosis of De Quervain tenosynovitis using logistic regression analysis.
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At the time of enrollment
|
|
Odds Ratio of Synovial Hypertrophy in CMC Joint Associated with Carpometacarpal Arthritis
Time Frame: At the time of enrollment
|
To assess the strength of association between ultrasonographic synovial hypertrophy and clinical diagnosis of carpometacarpal joint arthritis.
|
At the time of enrollment
|
|
Sensitivity of Ultrasonographic Parameters for Diagnosing Dorsoradial Wrist Pathologies
Time Frame: At the time of enrollment
|
To assess the diagnostic sensitivity of individual ultrasonographic findings (e.g., tendon sheath thickness, synovial hypertrophy) for detecting De Quervain tenosynovitis and CMC arthritis.
|
At the time of enrollment
|
|
Specificity of Ultrasonographic Parameters for Diagnosing Dorsoradial Wrist Pathologies
Time Frame: At the time of enrollment
|
To assess the diagnostic specificity of individual ultrasonographic findings for identifying De Quervain tenosynovitis and CMC arthritis.
|
At the time of enrollment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ilkyaz Yağar, Resident, University of Health Sciences, FSM Training and Research Hospital, Istanbul
- Study Director: Esra Giray, Associated Professor, University of Health Sciences, FSM Training and Research Hospital, Istanbul
- Study Chair: Aslınur Keleş, University of Health Sciences, FSM Training and Research Hospital, Istanbul
- Study Chair: Feyza Unlu Ozkan, Professor, University of Health Sciences, FSM Training and Research Hospital, Istanbul
- Study Chair: Ilknur Aktas, Professor, University of Health Sciences, FSM Training and Research Hospital, Istanbul
- Study Chair: Ozge Gulsum Illeez, Associated Professor, University of Health Sciences, FSM Training and Research Hospital, Istanbul
Publications and helpful links
General Publications
- McBain B, Rio E, Cook J, Grabinski R, Docking S. Diagnostic accuracy of imaging modalities in the detection of clinically diagnosed de Quervain's syndrome: a systematic review. Skeletal Radiol. 2019 Nov;48(11):1715-1721. doi: 10.1007/s00256-019-03195-z. Epub 2019 Mar 19.
- Montechiarello S, Miozzi F, D'Ambrosio I, Giovagnorio F. The intersection syndrome: Ultrasound findings and their diagnostic value. J Ultrasound. 2010 Jun;13(2):70-3. doi: 10.1016/j.jus.2010.07.009. Epub 2010 Sep 19.
- Look N, Mcnulty M, Rodriguez-Fontan F, Fenoglio AK. Radial-sided wrist pain differentials: presentation, pathoanatomy, diagnosis, and management. Medicina (B Aires). 2023;83(1):96-107.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Nervous System Diseases
- Muscular Diseases
- Neoplasms
- Neuromuscular Diseases
- Joint Diseases
- Connective Tissue Diseases
- Peripheral Nervous System Diseases
- Cysts
- Mucinoses
- Tendinopathy
- Mononeuropathies
- Tendon Entrapment
- Arthritis
- Ganglion Cysts
- De Quervain Disease
- Synovial Cyst
- Radial Neuropathy
Other Study ID Numbers
- E-10840098-202.3.02-3745
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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