Small Fiber NeuropathyNCT05380804
Cutaneous Silent Period Assessment in Primary Sjögren's Syndrome
An observational study of Small Fiber Neuropathy and Primary Sjögren Syndrome, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Primary Sjögren's syndrome (pSS) is a chronic, immune-mediated inflammatory disease mainly characterized by exocrine gland involvement. Beyond the wide heterogeneity in clinical presentation, neurological manifestation is one of the important systemic involvement of pSS. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Small Fiber Neuropathy, Primary Sjögren Syndrome
- What is being tested?
- cutaneous silent period (CSP) measurement
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2021to 28 Feb 2022
- 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: The study population composed of two groups: the patient group including the participants diagnosed with pSS in accordance with the 2016 ACR/EULAR primary Sjögren's Syndrome classification criteria and the control group including the healthy participants.
Who may be able to join
- Being between the ages of 18-65
- For the patient group, patients followed up in accordance with the 2016 ACR/EULAR primary Sjögren's Syndrome classification criteria
Who cannot join
- Any comorbidities that may cause neuropathy
- Any drugs that may cause neuropathy
- Chronic alcohol consumption
- A history of disease that may affect the central nervous system
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Education and Research Hospital
Istanbul, Pendik, 34899
About this study
Official title: Comparison of Cutaneous Silent Period Parameters in Patients With Primary Sjögren's Syndrome With the Healthy Population and Determination of Its Relationship With Clinical Parameters
Primary Sjögren's syndrome (pSS) is a chronic, immune-mediated inflammatory disease mainly characterized by exocrine gland involvement. Beyond the wide heterogeneity in clinical presentation, neurological manifestation is one of the important systemic involvement of pSS. The prevalence of neurological involvement varies widely from 10% to 60% in different series.
Small fiber neuropathy (SFN) as a popular clinical entity in recent years targets nociceptive thinly myelinated A-delta and unmyelinated C-fiber nerves and is frequently associated with burning and allodynic pain. Previous studies have demonstrated that SFN is frequently seen in patients with pSS and has an important clinical importance because it cannot be detected by routine electrophysiological studies. Various methods can be used in the detection of SFN, and cutaneous silent period (CSP) measurement is gaining popularity recently due to its non-invasiveness and practical fashion.
In this study, the investigators aimed to compare CSP parameters as an indicator of SFN in patients with pSS and in the healthy population and to reveal its relationship with clinical parameters.
- Conditions
- Small Fiber Neuropathy, Primary Sjögren Syndrome
- Being tested
- cutaneous silent period (CSP) measurement
- Keywords
- Small Fiber Neuropathy, Primary Sjögren Syndrome, Neuropathic Pain
- Medical subject headings
- Small Fiber Neuropathy, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cutaneous silent period (CSP) measurementDiagnostic test
CSP recordings are performed in the upper extremities using the same surface bar recording electrodes. Filters are set at 2 Hertz (Hz) to 10 kilo Hz, sensitivity is 200 microVolts (µV) and sweep speed is set at 200 milliseconds (ms). Stimulating electrode is placed on the index finger and recording bar electrode is placed on the abductor pollicis brevis (APB) muscle. During steady submaximal (50% of the maximal contraction) thumb abduction, 10 consecutive painful electrical stimuli of standard 80-milli Ampere (mA) intensity and 0.5-ms duration are applied to the index finger and responses are superimposed. CSP latency and duration are calculated and recorded. CSP latency is defined as the time between the stimulation and the onset of the silent period. CSP duration is calculated as the time interval between the beginning and end of the CSP.
| Study group | Role | What they receive |
|---|---|---|
| Patients with primary Sjögren's syndrome | Cutaneous silent period measurement was performed in patients with the primary Sjögren's syndrome classified according to the 2016 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) criteria. Receives: Diagnostic Test: cutaneous silent period (CSP) measurement | |
| Healthy population | Cutaneous silent period measurement was also performed in healthy population. Receives: Diagnostic Test: cutaneous silent period (CSP) measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the prevalence of the small fiber neuropathy in both groups
Cutaneous silent period measurements are done for detecting small fiber neuropathy in both groups. The latency and duration of CSP are recorded.
Measured: At baseline
Secondary outcomes (5)
Correlation between the number of the patients with small fiber neuropathy and score of the clinical disease severity
For assessing clinical disease severity, EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is used. The correlation between ESSPRI scores and CSP parameters is investigated. This assessment is done for only pSS group.
Measured: At baseline
Correlation between the number of the patients with small fiber neuropathy and scores of quality of life assessment.
For assessing quality of life, Short Form-36 (SF-36) is used. The correlation between SF-36 scores and CSP parameters is investigated. This assessment is done for only pSS group.
Measured: At baseline
Correlation between the number of the patients with small fiber neuropathy and scores of mood assessments.
For assessing mood, Hospital Anxiety and Depression Scale (HADS) is used. The correlation between HADS scores and CSP parameters is investigated. This assessment is done for only pSS group.
Measured: At baseline
Correlation between the number of the patients with small fiber neuropathy and number of patients with neuropathic pain
For assessing neuropathic pain, Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) is used. CSP parameters are compared between the patients with neuropathic pain according to the LANSS and the patients without neuropathic pain. This assessment is done for only pSS group.
Measured: At baseline
Correlation between the number of the patients with small fiber neuropathy and number of patients with central sensitization
For assessing central sensitization, Central Sensitization Inventory (CSI) is used. CSP parameters are compared between the patients with central sensitization according to the CSI and the patients without central sensitization. This assessment is done for only pSS group.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start4 Jan 2021
- Primary completion28 Jan 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Fiber NeuropathyStudies of the same condition, open and under way.
- More trials run by Marmara 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ozge Kenis-Coskun, MD, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380804
- Sponsor's protocol ID
- 09.2021.111
- Status last verified
- May 2022
- First submitted
- 21 Jan 2022
- Last updated
- 19 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cutaneous Silent Period Parameters in Patients With Primary Sjögren's Syndrome With the Healthy Population and Determination of Its Relationship With Clinical Parameters
- ClinicalTrials.gov ID
- NCT05380804
- Acronym / sponsor ID
- 09.2021.111
- Conditions
- Small Fiber Neuropathy, Primary Sjögren Syndrome
- Keywords
- Small Fiber Neuropathy, Primary Sjögren Syndrome, Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 19 May 2022 (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.
Primary Sjögren's syndrome (pSS) is a chronic, immune-mediated inflammatory disease mainly characterized by exocrine gland involvement. Beyond the wide heterogeneity in clinical presentation, neurological manifestation is one of the important systemic involvement of pSS. The prevalence of neurological involvement varies widely from 10% to 60% in different series.
Small fiber neuropathy (SFN) as a popular clinical entity in recent years targets nociceptive thinly myelinated A-delta and unmyelinated C-fiber nerves and is frequently associated with burning and allodynic pain. Previous studies have demonstrated that SFN is frequently seen in patients with pSS and has an important clinical importance because it cannot be detected by routine electrophysiological studies. Various methods can be used in the detection of SFN, and cutaneous silent period (CSP) measurement is gaining popularity recently due to its non-invasiveness and practical fashion.
In this study, the investigators aimed to compare CSP parameters as an indicator of SFN in patients with pSS and in the healthy population and to reveal its relationship with clinical parameters.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with primary Sjögren's syndrome | – | Diagnostic Test: cutaneous silent period (CSP) measurementCutaneous silent period measurement was performed in patients with the primary Sjögren's syndrome classified according to the 2016 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) criteria. |
| Healthy population | – | Diagnostic Test: cutaneous silent period (CSP) measurementCutaneous silent period measurement was also performed in healthy population. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population composed of two groups: the patient group including the participants diagnosed with pSS in accordance with the 2016 ACR/EULAR primary Sjögren's Syndrome classification criteria and the control group including the healthy participants.
Key inclusion criteria (2 listed)
- Being between the ages of 18-65
- For the patient group, patients followed up in accordance with the 2016 ACR/EULAR primary Sjögren's Syndrome classification criteria
Key exclusion criteria (4 listed)
- Any comorbidities that may cause neuropathy
- Any drugs that may cause neuropathy
- Chronic alcohol consumption
- A history of disease that may affect the central nervous system
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 |
|---|---|---|
| cutaneous silent period (CSP) measurementCSP recordings are performed in the upper extremities using the same surface bar recording electrodes. Filters are set at 2 Hertz (Hz) to 10 kilo Hz, sensitivity is 200 microVolts (µV) and sweep speed is set at 200 milliseconds (ms). Stimulating electrode is placed on the index finger and recording bar electrode is placed on the abductor pollicis brevis (APB) muscle. During steady submaximal (50% of the maximal contraction) thumb abduction, 10 consecutive painful electrical stimuli of standard 80-milli Ampere (mA) intensity and 0.5-ms duration are applied to the index finger and responses are superimposed. CSP latency and duration are calculated and recorded. CSP latency is defined as the time between the stimulation and the onset of the silent period. CSP duration is calculated as the time interval between the beginning and end of the CSP. | Diagnostic test | Healthy population, Patients with primary Sjögren's syndrome |
Primary outcome
Comparing the prevalence of the small fiber neuropathy in both groups
Time frame: At baseline
Cutaneous silent period measurements are done for detecting small fiber neuropathy in both groups. The latency and duration of CSP are recorded.
5 secondary outcomes
Correlation between the number of the patients with small fiber neuropathy and score of the clinical disease severity
Time frame: At baseline
Correlation between the number of the patients with small fiber neuropathy and scores of quality of life assessment.
Time frame: At baseline
Correlation between the number of the patients with small fiber neuropathy and scores of mood assessments.
Time frame: At baseline
Correlation between the number of the patients with small fiber neuropathy and number of patients with neuropathic pain
Time frame: At baseline
Correlation between the number of the patients with small fiber neuropathy and number of patients with central sensitization
Time frame: At baseline
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 19 May 2022.
Related trials for Small Fiber Neuropathy
Recruiting
Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
Sjögren's Syndrome, Small Fiber Neuropathy
Recruiting
Magnetic Brain Stimulation in Small Fiber Neuropathy
Small Fiber Neuropathy
Recruiting
Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Not yet recruitingPhase 4
Effect of Tirzepatide on Diabetic Peripheral Sensorimotor Neuropathy
Neuropathy, Small Fiber, Diabete Mellitus
Enrolling by invitation
Pilot Study to Evaluate Changes in Intra-Epidermal Nerve Fiber Density (IENFD) in Patients With Small-Fiber Neuropathy
Small Fiber Neuropathy
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.
Ozge Kenis-Coskun, MD study director
Marmara University
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 Small Fiber Neuropathy and Primary Sjögren Syndrome, run by Marmara 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 2 inclusion and 4 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 19 May 2022. 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?
Comparing the prevalence of the small fiber neuropathy in both groups (time frame: At baseline). 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 19 May 2022.