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

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ClinicalTrials.gov Identifier: NCT04985149
Recruitment Status : Recruiting
First Posted : August 2, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Aysun Ozlu, Kutahya Health Sciences University

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Electromyographic measurement: Other: Ultrasonographic measurement: Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Evaluation of the Sural Nerve With Ultrasonography and Electromyography in Patients With Fibromyalgia
Estimated Study Start Date : October 15, 2021
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Grup 1; participants with fibromyalgia
Participants with fibromyalgia
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).

Grup 2: patients without fibromyalgia
Patients without fibromyalgia
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).




Primary Outcome Measures :
  1. Fibromyalgia Impact Questionnaire (FEA) [ Time Frame: 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Neuropathic pain questionnaire [ Time Frame: 12 weeks ]
    Its Turkish validity and reliability were established. It is a questionnaire to evaluate and treat the pain of patients with pain problems, to determine exactly what type of pain they have, whether they have changed over time and their pain is in one or more areas. It consists of 12 questions. Each question is scored between 0 and 100 points. For example; If you do not have burning pain, you can score "0". If you have the worst type of burning pain imaginable, you can rate it "100".It is a questionnaire to evaluate and treat the pain of patients with pain problems, to determine exactly what type of pain they have, whether they have changed over time and their pain is in one or more areas. It consists of 12 questions. Each question is scored between 0 and 100 points.



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

Inclusion Criteria:

Criteria for Inclusion in the Research:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04985149


Contacts
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Contact: Aysun Ozlu, MD +90 505 3989 444 aysunozlu35@gmail.com

Locations
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Turkey
Kutahya Health Sciences University Recruiting
Kütahya, Turkey
Contact: Aysun Ozlu, MD    +90 505 3989 444    aysunozlu35@gmail.com   
Sponsors and Collaborators
Kutahya Health Sciences University
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Responsible Party: Aysun Ozlu, Principal Investigator, Kutahya Health Sciences University
ClinicalTrials.gov Identifier: NCT04985149    
Other Study ID Numbers: 2021-02/02
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aysun Ozlu, Kutahya Health Sciences University:
Pain
fibromyalgia
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases