Electrophysiological Findings in Fibromyalgia Patients

NCT04845737 | Completed

• 1 other identifier: AIBU-FTR-EY-03
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Fibromyalgia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  10 minutes

Secondary Outcomes (2)

• Visual analogue scale

  45 seconds

• Fibromyalgia Impact Questionnaire

  60 seconds

Study Arms (2)

Fibromyalgia patient group

OTHER

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

Control Group

OTHER

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

Interventions

sympathetic skin response measurement OTHER

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.

Also known as: measurement of vitamin d levels and hemogram evaluation

Control Group; Fibromyalgia patient group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Elif Yakşi

Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases

Study Officials

• Elif Yakşi

  Abant İzzet Baysal University Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: We have two groups.First group is fibromyalgia patient and second group is healty control.

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: April 15, 2021
• Study Start: June 7, 2021
• Primary Completion: July 20, 2022
• Study Completion: August 20, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

TU (1)