Evaluation of the Sural Nerve With Ultrasonography and Electromyography in Patients With Fibromyalgia

NCT04985149 | Unknown

• 1 other identifier: 2021-02/02
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

By evaluating the ultrasonographic and electromyographic measurements of the sural nerve in patients with and without a diagnosis of fibromyalgia; to determine the relationship of these measures to each other and to the FIQ, neuropathic pain questionnaire-Clinical, single-blind, prospective, controlled study.

Conditions

Fibromyalgia

Keywords

Pain; fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Fibromyalgia Impact Questionnaire (FEA)

  Functional status assessment will be evaluated with the Fibromyalgia Impact Questionnaire (FEA). The validity and reliability version of the questionnaire was done by Sarmer et al. made by (12). This scale; It measures 10 different features: physical function, well-being, not being able to go to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. With the exception of the well-being trait, low scores indicate recovery or less affliction. The maximum score is 100. The average FM patient scores 50, while more severely affected FM patients usually score above 70.All patients with and without fibromyalgia diagnosis who participated in the study will fill out a questionnaire, and their relationship with each other will be evaluated by making ultrasonographic and electromyographic measurement evaluations of the sural nerve. there is no follow-up planned in the future as the study participants will not be administered.

  12 weeks

Secondary Outcomes (1)

• Neuropathic pain questionnaire

  12 weeks

Study Arms (2)

Grup 1; participants with fibromyalgia

OTHER

Participants with fibromyalgia

Other: Electromyographic measurement:; Other: Ultrasonographic measurement:

Grup 2: patients without fibromyalgia

OTHER

Patients without fibromyalgia

Other: Electromyographic measurement:; Other: Ultrasonographic measurement:

Interventions

Electromyographic measurement: OTHER

Nerve conduction studies; assesses nerve function and includes motor, sensory, and mixed nerve tests. Micromed (Italy 2020) EMG device will be used in the electrophysiological examination. Sensory and motor conduction studies will be performed in the lower and upper extremities by paying attention to the extremity temperatures of the cases. Nerve conduction studies will be performed by another physician who is unaware of the diagnosis of the patients. Bilateral lower extremity sural sensory responses of the patients will be taken. In the antidromic method in sural nerve conduction examination, the bipolar superficial electrode is placed behind the lateral malleolus; stimulation will be made with bipolar surface electrodes 12-15 cm proximal to the recording site. Initial latency should be \< 3.8 ms, amplitude \> 10 Mv, and conduction velocity \> 36 m/sec in sensory response of the sural nerve.

Grup 1; participants with fibromyalgia; Grup 2: patients without fibromyalgia

Ultrasonographic measurement: OTHER

Sural nerve ultrasonography (US) will be performed by another clinician (Merve Akdeniz leblebicier) who is experienced in musculoskeletal ultrasonography and unaware of clinical evaluation, using a 6-18 Mhz linear probe. (Mindray -UMT 200, United States) Both sural nerve joints of the patients will be evaluated. The patient will lie on the stretcher in the prone position, the ankle will be out of the bed. The 14 cm above the malleolus will be marked as the main line, the nerve will be detected in the lateral of the tendon of the gastrocnemius muscle and the proximal of the saphenous vein. Nerve diameter measurement will be measured 3 times in mm2 and the average will be taken. Then, possible inflammatory pathologies will be ruled out by providing clinical confirmation using the Doppler mode (11).

Grup 1; participants with fibromyalgia; Grup 2: patients without fibromyalgia

Eligibility Criteria

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

You may qualify if:

• over 18 years old,
• Able to communicate in Turkish,
• It was planned to consist of individuals who were literate and agreed to participate in the study among patients without psychiatric disease.

You may not qualify if:

• Having a sensory defect or a disease that may cause sensory defect (DM, -Polyneuropathy, Parkinson's, Alzheimer's disease)
• Kby, patients with uncontrollable hormonal abnormality
• HIV, hcv, hbv, vasculitis, connective tissue disease
• Patients who have undergone saphenous vein surgery
• Patients who have received radiotherapy in the leg area
• Patients with cardiac pacemaker
• Patients undergoing treatment for malignancy and who have received kt that may lead to neuropathy
• Having problems with reading and writing,communication problem
• Those who are pregnant
• Those who are deficient in B12 and other B group vitamins

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aysun Ozlu, MD

CONTACT

+90 505 3989 444; aysunozlu35@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: August 2, 2021
• Study Start: October 15, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-06

Locations

TU (1)