Carpometacarpal (CMC) Joint ArthritisNCT06980779
The Correlation of Clinical and Ultrasonographic Findings in Dorsoradial Wrist Pain Patients: Cross Sectional Study
An observational study of Carpometacarpal (CMC) Joint Arthritis and Ganglion Cyst, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carpometacarpal (CMC) Joint Arthritis, Ganglion Cyst, De Quervain Disease
- What is being tested?
- ultrasonographic examination
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jul 2024to 6 Oct 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who referred physical theraphy and rehabilitation and orthopedia clinics with dorsoradial wrist and thumb pain
Who may be able to join
- pain in dorsoradial wrist
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, FSM Training and Research Hospital, Istanbul
Istanbul, ataşehir, 34752
About this study
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.
Read the 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.
- Conditions
- Carpometacarpal (CMC) Joint Arthritis, Ganglion Cyst, De Quervain Disease, Radial Neuropathy
- Being tested
- ultrasonographic examination
- Keywords
- carpometacarpal joint arthritis, ultrasonography, dorsoradial wrist pain, de Quervain disease, intersection syndrome, ganglion cyst
- Medical subject headings
- Capillary Malformations, Congenital, 1, Ganglion Cysts, De Quervain Disease, Radial Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographic examinationOther
ultrasonographic examination
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds Ratio of First Extensor Compartment Tendon Sheath Thickness Associated with De Quervain Disease
To quantify the association between increased tendon sheath thickness and clinical diagnosis of De Quervain tenosynovitis using logistic regression analysis.
Measured: At the time of enrollment
Odds Ratio of Synovial Hypertrophy in CMC Joint Associated with Carpometacarpal Arthritis
To assess the strength of association between ultrasonographic synovial hypertrophy and clinical diagnosis of carpometacarpal joint arthritis.
Measured: At the time of enrollment
Sensitivity of Ultrasonographic Parameters for Diagnosing Dorsoradial Wrist Pathologies
To assess the diagnostic sensitivity of individual ultrasonographic findings (e.g., tendon sheath thickness, synovial hypertrophy) for detecting De Quervain tenosynovitis and CMC arthritis.
Measured: At the time of enrollment
Specificity of Ultrasonographic Parameters for Diagnosing Dorsoradial Wrist Pathologies
To assess the diagnostic specificity of individual ultrasonographic findings for identifying De Quervain tenosynovitis and CMC arthritis.
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start29 Jul 2024
- Primary completion6 Oct 2024
- Study completion6 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carpometacarpal (CMC) Joint ArthritisStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ilkyazyagar, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- Ilkyaz Yağar, Resident, Principal investigator, University of Health Sciences, FSM Training and Research Hospital, IstanbulEsra Giray, Associated Professor, Study director, University of Health Sciences, FSM Training and Research Hospital, IstanbulAslınur Keleş, Study chair, University of Health Sciences, FSM Training and Research Hospital, IstanbulFeyza Unlu Ozkan, Professor, Study chair, University of Health Sciences, FSM Training and Research Hospital, IstanbulIlknur Aktas, Professor, Study chair, University of Health Sciences, FSM Training and Research Hospital, IstanbulOzge Gulsum Illeez, Associated Professor, Study chair, University of Health Sciences, FSM Training and Research Hospital, Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980779
- Sponsor's protocol ID
- E-10840098-202.3.02-3745
- Status last verified
- Jun 2024
- First submitted
- 23 Mar 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30888457Montechiarello 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.
PubMed 23396515Look 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.
PubMed 36774602
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation of Clinical and Ultrasonographic Findings in Dorsoradial Wrist Pain Patients: Cross Sectional Study
- ClinicalTrials.gov ID
- NCT06980779
- Acronym / sponsor ID
- E-10840098-202.3.02-3745
- Conditions
- Carpometacarpal (CMC) Joint Arthritis, Ganglion Cyst, De Quervain Disease, Radial Neuropathy
- Keywords
- carpometacarpal joint arthritis, ultrasonography, dorsoradial wrist pain, de Quervain disease, intersection syndrome, ganglion cyst
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 6 Oct 2024 (actual)
- Study completion
- 6 Oct 2024 (actual)
- First posted
- 20 May 2025 (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.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who referred physical theraphy and rehabilitation and orthopedia clinics with dorsoradial wrist and thumb pain
Key inclusion criteria (1 listed)
- pain in dorsoradial wrist
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| ultrasonographic examinationultrasonographic examination | Other | – |
Primary outcome
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.
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.
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.
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.
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 May 2025.
- Background: PubMed 30888457McBain 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.
- Background: PubMed 23396515Montechiarello 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.
- Background: PubMed 36774602Look 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.
- Individual participant dataSharing planned: Undecided
Related trials for Carpometacarpal (CMC) Joint Arthritis
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Recruiting
Woodcasting Versus Thermoplast Splint in CMC Arthroplasty
Carpometacarpal (CMC) Joint Arthritis
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.
Ilkyaz Yağar, Resident principal investigator
University of Health Sciences, FSM Training and Research Hospital, Istanbul
Esra Giray, Associated Professor study director
University of Health Sciences, FSM Training and Research Hospital, Istanbul
Aslınur Keleş study chair
University of Health Sciences, FSM Training and Research Hospital, Istanbul
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 Carpometacarpal (CMC) Joint Arthritis and Ganglion Cyst, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 6 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 May 2025. 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 Turkey (Türkiye). 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?
Odds Ratio of First Extensor Compartment Tendon Sheath Thickness Associated with De Quervain Disease (time frame: At the time of enrollment). The study lists 4 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 NCT06980779, which also lists 3 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 May 2025.