Carpal Tunnel SyndromeNCT05086029
Carpal Tunnel Syndrome in Patients With Psoriatic Arthritis
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 median nerve hypervasculatitation in psoriatic arthritis (PsA) patients with CTS or without CTS by using SMI, then compare them with normal people. 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?
- Superb Microvascular Imaging
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2019to 20 Sep 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 not included in the study if they had a history of wrist or hand fracture, surgery, neurologic disorders such as radiculopathy, polyneuropathy or cerebrovas-cular disease, a history of conditions associated with an increased incidence of CTS such as diabetes mellitus, pregnancy, hypothyroidism or severe systemic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carpal Tunnel Syndrome in Patients With Psoriatic Arthritis; Superb Microvascular Imaging Findings
This study aimed to investigate median nerve hypervasculatitation in psoriatic arthritis (PsA) patients with CTS or without CTS by using SMI, then compare them with normal people.
Read the detailed description
Carpal tunnel syndrome(CTS), a type of median nerve neuropathies, is the most common peripheral nerve entrapment syndrome. Most cases are idiopathic but CTS can be associated with rheumatologic disorders. There isn't any gold standard technique in diagnosis of CTS. Electrodiagnostic studies (EDS) are usually performed to confirm diagnose, to differentiate other diseases or to detect severity. But EDS have some disadvantages such as EDS are time consuming, uncomfortable, may require interventional procedures, can not directly assess the anatomy of the median nerve and its surrounding structures. For these reasons, the use of ultrasonography (US) in the diagnosis of carpal tunnel syndrome has been investigated for a long time. Most of them focused on the cross-sectional area(CSA) of median nerve. Fewer studies have investigated the vascularity of the median nerve. But there is conflict results because conventional Doppler techniques may fail to show small vessels or slow blood flow. Superb microvascular imaging (SMI) is a new ultrasound technology that can diferentiate blood flow signals from artifacts by using a new algorithm. In carpal tunnel syndrome hypervasularitation of median nerve has showed by SMI. To our best knowledge, there isn't any study assessing median nerve hypervascularity by using SMI in PsA. So we aimed to investigate median nerve hypervasculatitation in psoriatic arthritis (PsA) patients with CTS or without CTS by using SMI, then compare them with normal people.
- Conditions
- Carpal Tunnel Syndrome, Psoriatic Arthritis
- Being tested
- Superb Microvascular Imaging
- Keywords
- Carpal Tunnel Syndrome, Psoriatic Arthritis, Superb Microvascular 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.
Superb Microvascular ImagingDiagnostic test
Superb microvascular imaging (SMI) is a new ultrasound technology that can diferen-tiate blood flow signals from artifacts by using a new algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic arthritis patients | Not described Receives: Diagnostic Test: Superb Microvascular Imaging | |
| healthy volunteers | Not described Receives: Diagnostic Test: Superb Microvascular Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The blood flow display ratio of SMI in the median nerve
SMI signals will be graded from 0 to 3, in which 0 represented no signal, 1=one to two spot flow, 2= more than two spot flow or one to two strip blood flow (longer than 1 mm) and 3=more than two strip flow
Measured: 18 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 start20 Mar 2019
- Primary completion20 Sep 2020
- Study completion20 Sep 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
- 56 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
- NCT05086029
- Sponsor's protocol ID
- CTSINPSASMI
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- 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; Superb Microvascular Imaging Findings
- ClinicalTrials.gov ID
- NCT05086029
- Acronym / sponsor ID
- CTSINPSASMI
- Conditions
- Carpal Tunnel Syndrome, Psoriatic Arthritis
- Keywords
- Carpal Tunnel Syndrome, Psoriatic Arthritis, Superb Microvascular Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 20 Sep 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 median nerve hypervasculatitation in psoriatic arthritis (PsA) patients with CTS or without CTS by using SMI, then compare them with normal people.
Detailed description
Carpal tunnel syndrome(CTS), a type of median nerve neuropathies, is the most common peripheral nerve entrapment syndrome. Most cases are idiopathic but CTS can be associated with rheumatologic disorders. There isn't any gold standard technique in diagnosis of CTS. Electrodiagnostic studies (EDS) are usually performed to confirm diagnose, to differentiate other diseases or to detect severity. But EDS have some disadvantages such as EDS are time consuming, uncomfortable, may require interventional procedures, can not directly assess the anatomy of the median nerve and its surrounding structures. For these reasons, the use of ultrasonography (US) in the diagnosis of carpal tunnel syndrome has been investigated for a long time. Most of them focused on the cross-sectional area(CSA) of median nerve. Fewer studies have investigated the vascularity of the median nerve. But there is conflict results because conventional Doppler techniques may fail to show small vessels or slow blood flow. Superb microvascular imaging (SMI) is a new ultrasound technology that can diferentiate blood flow signals from artifacts by using a new algorithm. In carpal tunnel syndrome hypervasularitation of median nerve has showed by SMI. To our best knowledge, there isn't any study assessing median nerve hypervascularity by using SMI in PsA. So we aimed to investigate median nerve hypervasculatitation in psoriatic arthritis (PsA) patients with CTS or without CTS by using SMI, then compare them with normal people.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriatic arthritis patients | – | Diagnostic Test: Superb Microvascular Imaging |
| healthy volunteers | – | Diagnostic Test: Superb Microvascular 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 not included in the study if they had a history of wrist or hand fracture, surgery, neurologic disorders such as radiculopathy, polyneuropathy or cerebrovas-cular disease, a history of conditions associated with an increased incidence of CTS such as diabetes mellitus, pregnancy, hypothyroidism or severe systemic diseases.
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 |
|---|---|---|
| Superb Microvascular ImagingSuperb microvascular imaging (SMI) is a new ultrasound technology that can diferen-tiate blood flow signals from artifacts by using a new algorithm. | Diagnostic test | Psoriatic arthritis patients, healthy volunteers |
Primary outcome
The blood flow display ratio of SMI in the median nerve
Time frame: 18 months
SMI signals will be graded from 0 to 3, in which 0 represented no signal, 1=one to two spot flow, 2= more than two spot flow or one to two strip blood flow (longer than 1 mm) and 3=more than two strip flow
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 blood flow display ratio of SMI in the median nerve (time frame: 18 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.