Carpal Tunnel SyndromeNCT05086042
Carpal Tunnel Syndrome in Patients With Psoriatic Arthritis; Ultrasonography and Magnetic Resonance Imaging Findings
An observational study of Carpal Tunnel Syndrome and Psoriatic Arthritis, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome, Psoriatic Arthritis
- What is being tested?
- Ultrasonography, Magnetic resonance imaging
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2019to 15 Mar 2020
- 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: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome, Psoriatic Arthritis
- Being tested
- Ultrasonography, Magnetic resonance imaging
- Keywords
- Carpal Tunnel Syndrome, Psoriatic Arthritis, Ultrasonography, magnetic resonance imaging
- Medical subject headings
- Carpal Tunnel Syndrome, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography, Magnetic resonance imagingDiagnostic test
The cross-sectional area of the median nerve was measured with US and MRI.
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic arthritis patients | Not described Receives: Diagnostic Test: Ultrasonography, Magnetic resonance imaging | |
| healthy volunteers | Not described Receives: Diagnostic Test: Ultrasonography, Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cross-sectional area of the median nerve measured by US and MRI
The measurement will be made at the pisiform bone level and with the continuous trace method.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start15 Mar 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi AKYILDIZ TEZCAN, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086042
- Sponsor's protocol ID
- CTSINPSAUSMRI
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carpal Tunnel Syndrome in Patients With Psoriatic Arthritis; Ultrasonography and Magnetic Resonance Imaging Findings
- ClinicalTrials.gov ID
- NCT05086042
- Acronym / sponsor ID
- CTSINPSAUSMRI
- Conditions
- Carpal Tunnel Syndrome, Psoriatic Arthritis
- Keywords
- Carpal Tunnel Syndrome, Psoriatic Arthritis, Ultrasonography, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 20 Oct 2021 (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 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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriatic arthritis patients | – | Diagnostic Test: Ultrasonography, Magnetic resonance imaging |
| healthy volunteers | – | Diagnostic Test: Ultrasonography, Magnetic resonance imaging |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Ultrasonography, Magnetic resonance imagingThe cross-sectional area of the median nerve was measured with US and MRI. | Diagnostic test | Psoriatic arthritis patients, healthy volunteers |
Primary outcome
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.
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 Oct 2021.
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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 Carpal Tunnel Syndrome and Psoriatic Arthritis, run by Selcuk University 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 1 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 Oct 2021. 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?
The cross-sectional area of the median nerve measured by US and MRI (time frame: 12 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 20 Oct 2021.