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Electrophysiological Findings in Fibromyalgia Patients

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
sympathetic skin response measurement
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fibromyalgia focused on measuring sympathetic skin response, inflammatory parameters, autonomic dysfunction, autonomic nervous system

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-65 years old To be diagnosed with FMS according to the criteria of American College of Rheumatology (ACR) 2010 Confirmed diagnosis of FMS according to American College of Rheumatology (ACR) 2016 criteria

Exclusion Criteria:

  • Presence of acute infection Diabetes Mellitus B12 deficiency Hypothyroidism Inflammatory-rheumatological disease presence A history of malignancy Major psychiatric disorder Dementia, etc. diseases that may cause loss of cognitive functions

Sites / Locations

  • Elif Yakşi

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Fibromyalgia patient group

Control Group

Arm Description

Sympathetic skin response measurements will be made in patients who meet the diagnosis criteria of fibromyalgia. Vitamin D levels will be measured and hemogram values will be checked in these patients.

The participant in this group will be chosen from healthy volunteers. Sympathetic skin response will be measured of the participants. Vitamin D levels and hemogram values will be recorded.

Outcomes

Primary Outcome Measures

Sympathetic Skin Response
Sympathetic Skin Response (SSR) measurement will be made at room temperature of 25 ºC, while the patients are resting in the supine position.For upper extremity SSR evaluation, the active (-) electrode will be placed in the palmar area, the reference electrode (+) in the dorsum of the hand, and the ground electrode in the forearm. Similarly, in the lower extremity, the active electrode will be placed on the sole of the foot and the reference electrode will be placed on the back of the foot. The same side median nerve will be stimulated from the second finger, and the SSR obtained from the right upper and lower extremities will be evaluated. The duration of the warning will be adjusted to be 0.1 ms and the intensity of the warning to be 15-20 mA. In order to prevent habituation, warnings will be given at different intervals and with> 30 seconds between warning. A maximum of 5 unilateral stimulation will be applied to each patient.

Secondary Outcome Measures

Visual analogue scale
It is used to convert some values that cannot be measured numerically into numerical ones. Two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line and the patient is asked to indicate where his condition is appropriate by drawing a line or by placing a point or pointing on this line.
Fibromyalgia Impact Questionnaire
It measures 10 different characteristics: physical function, feeling unwell, absenteeism, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. Except for the sense of well-being, lower scores indicate improvement or less affected by the disease. The Fibromyalgia Impact Questionnaire is filled out by the patient. The maximum possible score for each subtitle is 10 points. Thus the total maximum score is 100 points

Full Information

First Posted
March 17, 2021
Last Updated
October 12, 2022
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT04845737
Brief Title
Electrophysiological Findings in Fibromyalgia Patients
Official Title
Evaluation of the Relationship Between Electrophysiological Findings With Vitamin D Levels and Inflammatory Parameters in Fibromyalgia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
July 20, 2022 (Actual)
Study Completion Date
August 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Fibromyalgia Syndrome (FMS); It is a chronic condition characterized by widespread body pain, sleep disturbance, fatigue, impaired cognitive functions, and anxiety (1). FMS; chronic fatigue syndrome, interstitial cystitis, irritable bowel syndrome, temperomandibular joint dysfunction, myofascial pain, functional dyspepsia, restless leg syndrome and posttraumatic stress disorder are among central sensitization syndromes (2,3).
Detailed Description
Etiology and pathogenesis in fibromyalgia have not been fully elucidated. Many mechanisms contribute to the formation of FMS. Many evidence has been found for dysfunction of the central and autonomic nervous system, immune system, cytokines, neurotransmitters and hormones, which are thought to play a role in the disease. Since increasing systemic inflammation is thought to have a role in the etiopathogenesis of FMS, there are increasing numbers of studies focusing on this aspect of fibromyalgia. Neutrophil / lymphocyte ratio (NLR) and platelet / lymphocyte ratio (PLR) in peripheral blood are simple markers of systemic inflammatory response. Another factor thought to have a role in etiopathogenesis is autonomic nervous system dysfunction. It has been found that there is autonomic dysfunction in the sympathetic nervous system in patients with FMS. Sympathetic skin response measurements are frequently used electrophysiological methods to evaluate the functionality of the sympathetic nervous system, which is a component of the autonomic nervous system. In addition, vitamin D deficiency is common in FMS patients. In a study, inadequate vitamin D levels were found in 45% of fibromyalgia patients. When a literature review is performed, it is seen that electrophysiological studies are performed to evaluate autonomic dysfunction in patients with fibromyalgia. No studies were found showing the relationship between vitamin D levels and inflammatory parameters in patients with fibromyalgia and electrophysiological findings. In our study, it was aimed to compare the autonomic dysfunction of fibromyalgia patients with healthy volunteers by electrophysiological evaluation and to investigate the relationship between vitamin D levels and inflammatory parameters in fibromyalgia patients and the data obtained from electrophysiological studies. In this way, we aimed to contribute to a better understanding of the physiopathology of fibromyalgia patients with autonomic dysfunction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
sympathetic skin response, inflammatory parameters, autonomic dysfunction, autonomic nervous system

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We have two groups.First group is fibromyalgia patient and second group is healty control.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fibromyalgia patient group
Arm Type
Other
Arm Description
Sympathetic skin response measurements will be made in patients who meet the diagnosis criteria of fibromyalgia. Vitamin D levels will be measured and hemogram values will be checked in these patients.
Arm Title
Control Group
Arm Type
Other
Arm Description
The participant in this group will be chosen from healthy volunteers. Sympathetic skin response will be measured of the participants. Vitamin D levels and hemogram values will be recorded.
Intervention Type
Other
Intervention Name(s)
sympathetic skin response measurement
Other Intervention Name(s)
measurement of vitamin d levels and hemogram evaluation
Intervention Description
Sympathetic skin response(SSR) was studied with upper and lower extremity hand and foot recording of all participants, and amplitude and latency values will be recorded. SSR measurement will be made at room temperature of 25 ºC, while the patients are resting in the supine position. 6 mm silver disc electrodes will be used as the recording electrode. The relationship between the patients' vitamin D levels and inflammatory response markers and their sympathetic skin responses will be investigated by statistical analysis.
Primary Outcome Measure Information:
Title
Sympathetic Skin Response
Description
Sympathetic Skin Response (SSR) measurement will be made at room temperature of 25 ºC, while the patients are resting in the supine position.For upper extremity SSR evaluation, the active (-) electrode will be placed in the palmar area, the reference electrode (+) in the dorsum of the hand, and the ground electrode in the forearm. Similarly, in the lower extremity, the active electrode will be placed on the sole of the foot and the reference electrode will be placed on the back of the foot. The same side median nerve will be stimulated from the second finger, and the SSR obtained from the right upper and lower extremities will be evaluated. The duration of the warning will be adjusted to be 0.1 ms and the intensity of the warning to be 15-20 mA. In order to prevent habituation, warnings will be given at different intervals and with> 30 seconds between warning. A maximum of 5 unilateral stimulation will be applied to each patient.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Visual analogue scale
Description
It is used to convert some values that cannot be measured numerically into numerical ones. Two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line and the patient is asked to indicate where his condition is appropriate by drawing a line or by placing a point or pointing on this line.
Time Frame
45 seconds
Title
Fibromyalgia Impact Questionnaire
Description
It measures 10 different characteristics: physical function, feeling unwell, absenteeism, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. Except for the sense of well-being, lower scores indicate improvement or less affected by the disease. The Fibromyalgia Impact Questionnaire is filled out by the patient. The maximum possible score for each subtitle is 10 points. Thus the total maximum score is 100 points
Time Frame
60 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-65 years old To be diagnosed with FMS according to the criteria of American College of Rheumatology (ACR) 2010 Confirmed diagnosis of FMS according to American College of Rheumatology (ACR) 2016 criteria Exclusion Criteria: Presence of acute infection Diabetes Mellitus B12 deficiency Hypothyroidism Inflammatory-rheumatological disease presence A history of malignancy Major psychiatric disorder Dementia, etc. diseases that may cause loss of cognitive functions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Yakşi
Organizational Affiliation
Abant İzzet Baysal University Medical Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elif Yakşi
City
Bolu
ZIP/Postal Code
14030
Country
Turkey

12. IPD Sharing Statement

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Electrophysiological Findings in Fibromyalgia Patients

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