Electrophysiological Findings in Fibromyalgia Patients

• ClinicalTrials.gov Identifier: NCT04845737
• Recruitment Status: Not yet recruiting
• First Posted: April 15, 2021
• Last Update Posted: May 6, 2021
• Sponsor: Abant Izzet Baysal University
• Information provided by (Responsible Party): Elif yaksi, Abant Izzet Baysal University

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).

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Other: sympathetic skin response measurement	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: We have two groups.First group is fibromyalgia patient and second group is healty control.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluation of the Relationship Between Electrophysiological Findings With Vitamin D Levels and Inflammatory Parameters in Fibromyalgia Patients
• Estimated Study Start Date: May 7, 2021
• Estimated Primary Completion Date: October 20, 2021
• Estimated Study Completion Date: November 20, 2021

Arms and Interventions

Arm	Intervention/treatment
Fibromyalgia patient group; 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.	Other: sympathetic skin response measurement; 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.; Other Name: measurement of vitamin d levels and hemogram evaluation
Control Group; 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.	Other: sympathetic skin response measurement; 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.; Other Name: measurement of vitamin d levels and hemogram evaluation

Outcome Measures

Primary Outcome Measures :

1. Sympathetic Skin Response [ Time Frame: 10 minutes ]
   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 :

1. Visual analogue scale [ Time Frame: 45 seconds ]
   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.
2. Fibromyalgia Impact Questionnaire [ Time Frame: 60 seconds ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Elif Yakşi; +905069078505 ext MD; elifyaksi@hotmail.com

Locations

Turkey

Elif Yakşi

Bolu, Turkey, 14030

Sponsors and Collaborators

Abant Izzet Baysal University

Investigators

• Principal Investigator: Elif Yakşi; Abant İzzet Baysal University Medical Faculty

More Information

• Responsible Party: Elif yaksi, MD, Abant Izzet Baysal University
• ClinicalTrials.gov Identifier: NCT04845737
• Other Study ID Numbers: AIBU-FTR-EY-03
• First Posted: April 15, 2021
• Last Update Posted: May 6, 2021
• Last Verified: April 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elif yaksi, Abant Izzet Baysal University:

sympathetic skin response; inflammatory parameters; autonomic dysfunction; autonomic nervous system

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Vitamin D; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents