The Correlation of Clinical and Ultrasonographic Findings in Dorsoradial Wrist Pain Patients: Cross Sectional Study

May 12, 2025 updated by: ilkyazyagar, Fatih Sultan Mehmet Training and Research Hospital
This study aims to investigate the correlation between ultrasonographic and clinical findings in dorsoradial wrist pain. There are several etiologies for dorsoradial wrist pain, including carpometacarpal joint arthritis, De Quervain's tenosynovitis, proximal and distal intersection syndrome, Wartenberg syndrome, and ganglion cysts. In these clinical scenarios, certain physical examination tests are utilized, such as the Finkelstein test for De Quervain's tenosynovitis; however, this test may also yield positive results in cases of severe joint arthritis. Ultrasonography is proposed as a complementary tool for differential diagnosis. The investigators aim to examine the correlation between clinical test results and ultrasonographic parameters such as tendon thickness in the first extensor compartment, carpometacarpal joint synovitis, cortical irregularities, and the presence of osteophytes. Functional status will be assessed using the QuickDASH and FIHOA questionnaires.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ataşehir
      • Istanbul, Ataşehir, Turkey, 34752
        • University of Health Sciences, FSM Training and Research Hospital, Istanbul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients who referred physical theraphy and rehabilitation and orthopedia clinics with dorsoradial wrist and thumb pain

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fatih Sultan Mehmet Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-10840098-202.3.02-3745

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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