Electrophysiological Findings in Fibromyalgia Patients

Not Applicable

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT04845737
• Lead Sponsor: Abant Izzet Baysal University

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.

Study Timeline

• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-15
• Study Start: 2021-06-07
• Primary Completion: 2022-07-20
• Study Completion: 2022-08-20
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sympathetic Skin Response	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

Name	Time	Method
Visual analogue scale	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.
Fibromyalgia Impact Questionnaire	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

Trial Locations

Locations (1)

Elif Yakşi; 🇹🇷 Bolu, Turkey