- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05086042
Carpal Tunnel Syndrome in Patients With Psoriatic Arthritis; Ultrasonography and Magnetic Resonance Imaging Findings
October 7, 2021 updated by: Ezgi AKYILDIZ TEZCAN, Selcuk University
This study aimed to investigate relationship between CTS diagnosis with electrodiagnostic studies and median nerve's cross-sectional area measered by US and MRI in PsA patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Carpal tunnel syndrome (CTS) is a type of entrapment neuropathy, caused by compression of the median nerve in the carpal tunnel at the wrist1.
It accounts for about 90% of all entrapment neuropathies.
But there is no gold standard technique for diagnosing CTS.
Electrodiagnostic studies (EDS) are generally used in differential diagnosis because the symptoms may be difficult to interpret.
Unfortunetely EDS has some limitations.
The factors can limit EDS are that it is not comfortable for patients and physicians, may require interventional procedures, need patient cooperation, provide limited information on the etiology of CTS, time consuming, and can not be used in some patient groups such as patients with dermatological contraindications.
Recent years, magnetic resonance imaging (MRI) and ultrasonography (US) have facilitated the diagnosis of CTS.
The median nerve cross-sectional area (CSA) measured by US or MRI has been found to be associated with CTS.
However, there are studies with conflicting results regarding the median nerve CSA in patients with rheumatic diseases.
Psoriatic arthritis (PsA), a kind of rheumatic disease, occurs in up to 30% of people with psoriasis and can have serious debilitating effects on the peripheral joints, spine, tendon insertions, and fingers.
To our knowlage, any study didn't assess MRI measurements of median nerve CSA in PsA patients.
In this study we aimed to assess CTS's US and MRI findings in patients with PsA and compare them healty controls.
Study Type
Observational
Enrollment (Actual)
67
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
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Konya, Turkey
- Selçuk University Faculty of Medicine
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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
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
PsA patients according to the CASPAR criteria who consecutively applied to the FTR outpatient clinic for PsA follow-up and healthy volunteers who applied to the FTR outpatient clinic enrolled in the study.
Description
Inclusion Criteria:
- PsA patients according to the CASPAR criteria who consecutively applied to the FTR outpatient clinic for PsA follow-up and healthy volunteers who applied to the FTR outpatient clinic enrolled in the study.
Exclusion Criteria:
- Patients were excluded from the study if they had history of conditions associated with an increased incidence of CTS except PsA (diabetes mellitus, pregnancy, hypothyroidism, renal failure or other severe systemic diseases); history or clinical/electrophyscologic finding of radiculopathy, plexopathy, polyneuropathy or any nervous system diseases; history of fractures, severe trauma or surgical interventions involving the wrist; bifid median nerve on wrist imaging and under the age of 18, over the age of 65. There was no history of rheumatic disease in the healthy volunteer group.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
healthy volunteers
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The cross-sectional area of the median nerve was measured with US and MRI.
|
|
Psoriatic arthritis patients
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The cross-sectional area of the median nerve was measured with US and MRI.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The cross-sectional area of the median nerve measured by US and MRI
Time Frame: 12 months
|
The measurement will be made at the pisiform bone level and with the continuous trace method.
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2019
Primary Completion (Actual)
March 15, 2020
Study Completion (Actual)
March 15, 2020
Study Registration Dates
First Submitted
October 7, 2021
First Submitted That Met QC Criteria
October 7, 2021
First Posted (Actual)
October 20, 2021
Study Record Updates
Last Update Posted (Actual)
October 20, 2021
Last Update Submitted That Met QC Criteria
October 7, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Skin Diseases
- Wounds and Injuries
- Disease
- Joint Diseases
- Musculoskeletal Diseases
- Neuromuscular Diseases
- Mononeuropathies
- Peripheral Nervous System Diseases
- Median Neuropathy
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Skin Diseases, Papulosquamous
- Spinal Diseases
- Bone Diseases
- Spondylarthropathies
- Spondylarthritis
- Spondylitis
- Psoriasis
- Syndrome
- Arthritis
- Carpal Tunnel Syndrome
- Arthritis, Psoriatic
Other Study ID Numbers
- CTSINPSAUSMRI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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