Carpal Tunnel Syndrome Evaluation With Ultrasound in Rheumatoid Arthritis Patients
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| ClinicalTrials.gov Identifier: NCT06012630 |
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Recruitment Status :
Completed
First Posted : August 25, 2023
Last Update Posted : August 25, 2023
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Sponsor:
Burak Tayyip Dede
Information provided by (Responsible Party):
Burak Tayyip Dede, Istanbul Training and Research Hospital
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Brief 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. 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Median Nerve Entrapment | Diagnostic Test: Ultarsound |
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 90 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Target Follow-Up Duration: | 8 Months |
| Official Title: | Ultrasound Evaluation of the Median Nerve in Patients With Rheumatoid Arthritis and Its Relationship With Disease Activity |
| Actual Study Start Date : | January 15, 2023 |
| Actual Primary Completion Date : | July 1, 2023 |
| Actual Study Completion Date : | August 15, 2023 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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group 1: RA without CTS
Rheumatoid arthritis patients without a diagnosis of CTS based on clinical findings and physical examination
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Diagnostic Test: Ultarsound
Median nerve evaluation of participants with ultrasound |
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group 2: RA with CTS
Rheumatoid arthritis patients with a diagnosis of CTS based on clinical findings and physical examination
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Diagnostic Test: Ultarsound
Median nerve evaluation of participants with ultrasound |
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group:3 Healthy Control
Healthy Control without rheumatologic disease and Carpal tunnel syndrome
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Diagnostic Test: Ultarsound
Median nerve evaluation of participants with ultrasound |
Primary Outcome Measures :
- Comparison of US findings among participants [ Time Frame: 6 months ]Comparison of US findings among participants
Secondary Outcome Measures :
- Relationship between US findings and disease activity in the patient group [ Time Frame: 6 months ]The correlation between the US findings of the participants in the patient group and the CDA, which evaluates disease activity, was examined.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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.
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- thoese with hypothyroidism,
- gout,
- diabetes mellitus,
- history of CTS surgery,
- upper extremity plexopathy,
- polinöropathy,
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06012630
Locations
| Turkey | |
| Istanbul Training and Resarch Hospital | |
| Istanbul, Turkey | |
Sponsors and Collaborators
Burak Tayyip Dede
| Responsible Party: | Burak Tayyip Dede, Physical Medicine and Rehabilitation, Istanbul Training and Research Hospital |
| ClinicalTrials.gov Identifier: | NCT06012630 |
| Other Study ID Numbers: |
22/04/2022; 2011-KAEK-50;126 |
| First Posted: | August 25, 2023 Key Record Dates |
| Last Update Posted: | August 25, 2023 |
| Last Verified: | August 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Burak Tayyip Dede, Istanbul Training and Research Hospital:
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Rheumatoid arthritis Ultrasound Carpal Tunnel Syndrome |
Additional relevant MeSH terms:
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Arthritis Arthritis, Rheumatoid Carpal Tunnel Syndrome Nerve Compression Syndromes Median Neuropathy Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries |