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

NCT04985149 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-09-16

No results posted yet for this study

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

Interventions

OTHER

Electromyographic measurement:

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.

OTHER

Ultrasonographic measurement:

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).

Sponsors & Collaborators

  • Kutahya Health Sciences University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2021-12-01
Completion
2021-12-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04985149 on ClinicalTrials.gov