Median Nerve EntrapmentNCT06012630
Carpal Tunnel Syndrome Evaluation With Ultrasound in Rheumatoid Arthritis Patients
An observational study of Median Nerve Entrapment, run by Burak Tayyip Dede at 1 site in Turkey (Türkiye).
Trial summary
In rheumatoid arthritis (RA) patients, the diagnosis of Carpal tunnel syndrome (CTS) was made based on clinical findings and physical examinations. Then, the cross-sectional areas of the participants' median nerves from different levels were measured. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Median Nerve Entrapment
- What is being tested?
- Ultarsound
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2023to 15 Aug 2023
- How long will I take part?
- 8 Months
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: RA patients identified according to the 2010 American College of Rheumatology/Europan Leage Against Rheumatism classification criteria healthy controls (HC) with no history of rheumatic diseases and CTS.
Who may be able to join
- RA patients identified according to the 2010 American College of Rheumatology/Europan Leage Against Rheumatism classification criteria
- healthy controls (HC) with no history of rheumatic diseases and CTS.
- Individuals aged 18-65 years.
Who cannot join
- thoese with hypothyroidism,
- gout,
- diabetes mellitus,
- history of CTS surgery,
- upper extremity plexopathy,
- polinöropathy,
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- uncontrollable fibromyalgia,
- steroid injection for CTS
- For the HC group, those with phalen or tinnel detected in at least one wrist and those with bifid median nerve detected during US evaluation were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Resarch Hospital
Istanbul
About this study
Official title: Ultrasound Evaluation of the Median Nerve in Patients With Rheumatoid Arthritis and Its Relationship With Disease Activity
In rheumatoid arthritis (RA) patients, the diagnosis of Carpal tunnel syndrome (CTS) was made based on clinical findings and physical examinations. Then, the cross-sectional areas of the participants' median nerves from different levels were measured. Meidolateral and anteroposterior diameter were measured at the level of the carpal tunnel inlet. Flattening ratio was calculated. wrist to forearm ratio and wrist to forearm difference were calculated. The obtained data were compared between RA with CTS, RA without CTS and healthy control.
- Conditions
- Median Nerve Entrapment
- Being tested
- Ultarsound
- Keywords
- Rheumatoid arthritis, Ultrasound, Carpal Tunnel Syndrome
- Medical subject headings
- Median Neuropathy, Arthritis, Rheumatoid, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltarsoundDiagnostic test
Median nerve evaluation of participants with ultrasound
| Study group | Role | What they receive |
|---|---|---|
| group 1: RA without CTS | Rheumatoid arthritis patients without a diagnosis of CTS based on clinical findings and physical examination Receives: Diagnostic Test: Ultarsound | |
| group 2: RA with CTS | Rheumatoid arthritis patients with a diagnosis of CTS based on clinical findings and physical examination Receives: Diagnostic Test: Ultarsound | |
| group:3 Healthy Control | Healthy Control without rheumatologic disease and Carpal tunnel syndrome Receives: Diagnostic Test: Ultarsound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of US findings among participants
Comparison of US findings among participants
Measured: 6 months
Secondary outcomes (1)
Relationship between US findings and disease activity in the patient group
The correlation between the US findings of the participants in the patient group and the CDA, which evaluates disease activity, was examined.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start15 Jan 2023
- Primary completion1 Jul 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Median Nerve EntrapmentStudies 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
- Cross-sectional
- Enrolment
- 90 participants (actual)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Burak Tayyip Dede
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Burak Tayyip Dede, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012630
- Sponsor's protocol ID
- 22/04/2022; 2011-KAEK-50;126
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of the Median Nerve in Patients With Rheumatoid Arthritis and Its Relationship With Disease Activity
- ClinicalTrials.gov ID
- NCT06012630
- Acronym / sponsor ID
- 22/04/2022; 2011-KAEK-50;126
- Conditions
- Median Nerve Entrapment
- Keywords
- Rheumatoid arthritis, Ultrasound, Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Burak Tayyip DedeOther government
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 25 Aug 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.
In rheumatoid arthritis (RA) patients, the diagnosis of Carpal tunnel syndrome (CTS) was made based on clinical findings and physical examinations. Then, the cross-sectional areas of the participants' median nerves from different levels were measured. Meidolateral and anteroposterior diameter were measured at the level of the carpal tunnel inlet. Flattening ratio was calculated. wrist to forearm ratio and wrist to forearm difference were calculated. The obtained data were compared between RA with CTS, RA without CTS and healthy control.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 8 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1: RA without CTS | – | Diagnostic Test: UltarsoundRheumatoid arthritis patients without a diagnosis of CTS based on clinical findings and physical examination |
| group 2: RA with CTS | – | Diagnostic Test: UltarsoundRheumatoid arthritis patients with a diagnosis of CTS based on clinical findings and physical examination |
| group:3 Healthy Control | – | Diagnostic Test: UltarsoundHealthy Control without rheumatologic disease and Carpal tunnel syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- RA patients identified according to the 2010 American College of Rheumatology/Europan Leage Against Rheumatism classification criteria healthy controls (HC) with no history of rheumatic diseases and CTS.
Key inclusion criteria (3 listed)
- RA patients identified according to the 2010 American College of Rheumatology/Europan Leage Against Rheumatism classification criteria
- healthy controls (HC) with no history of rheumatic diseases and CTS.
- Individuals aged 18-65 years.
Key exclusion criteria (9 listed)
- thoese with hypothyroidism,
- gout,
- diabetes mellitus,
- history of CTS surgery,
- upper extremity plexopathy,
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 |
|---|---|---|
| UltarsoundMedian nerve evaluation of participants with ultrasound | Diagnostic test | group 1: RA without CTS, group 2: RA with CTS, group:3 Healthy Control |
Primary outcome
Comparison of US findings among participants
Time frame: 6 months
Comparison of US findings among participants
1 secondary outcome
Relationship between US findings and disease activity in the patient group
Time frame: 6 months
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 25 Aug 2023.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Median Nerve Entrapment, run by Burak Tayyip Dede 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 3 inclusion and 9 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 25 Aug 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 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?
Comparison of US findings among participants (time frame: 6 months). 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 25 Aug 2023.