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Neuromuscular Ultrasonography Utility for Detection of Peripheral Neuropathy in Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT04527172
Recruitment Status : Completed
First Posted : August 26, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Amira M elSonbaty, Assiut University

Brief Summary:
This study aims to evaluate the rule of NMUS in detection of peripheral neuropathy in SLE patient and to correlate it to traditional neurophysiological studies, clinical signs and activity of SLE.

Condition or disease Intervention/treatment
Peripheral Neuropathy System; Lupus Erythematosus Diagnostic Test: neuromuscular ultrasound

Detailed Description:

The frequency of SLE peripheral neuropathy documented by electrophysiology has been estimated to be approximately 30%.

The term peripheral neuropathies include symmetric polyneuropathy, single and multiple mononeuropathy, and radiculopathy.

There has been increasing interest in using ultrasonography (US) to aid peripheral neuropathy diagnosis and studies have shown good correlation with other imaging modalities. US is a non-invasive and inexpensive imaging device that has become widely available as a diagnostic tool at many fields.

so systemic lupus patients were enrolled in the study , performed nerve conduction study and neuromuscular ultrasound for bil. median, ulnar, peroneal, tibial and sural nerves , on statistics the cross sections were compared in neurophusiologically affected and non affected nerves, also the sensitivity and specifity of NMUS in comparison to the traditional NCS was calculated

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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Neuromuscular Ultrasonography Utility for Detection of Peripheral Neuropathy in Systemic Lupus Erythematosus
Actual Study Start Date : May 20, 2018
Actual Primary Completion Date : May 28, 2019
Actual Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
systemic lupus patients
Nerve conduction study and neuromuscular ultrasound for median , ulnar, tibial, peroneal and sural nerves
Diagnostic Test: neuromuscular ultrasound
ultrasound to visualize the peripheral nerves of lupus patients and to compare it with results of the raditional electrophysiological studies
Other Name: nerve conduction study

Healthy subjects
Nerve conduction study and neuromuscular ultrasound for median , ulnar, tibial, peroneal and sural nerves
Diagnostic Test: neuromuscular ultrasound
ultrasound to visualize the peripheral nerves of lupus patients and to compare it with results of the raditional electrophysiological studies
Other Name: nerve conduction study




Primary Outcome Measures :
  1. evaluate the rule of NMUS in detection of peripheral neuropathy in SLE patient [ Time Frame: 6months ]
    Measuring sensitivity and specificity of neuromuscular ultrasound in comparison to nerve conduction study

  2. Describing the patterns of peripheral nerve affection in SLE patient [ Time Frame: 6months ]
    Evaluating different studied nerves clinically, electrophyiologically and by neuromuscular ultrasonography



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All adult SLE patientA who was admitted to Rheumatology & Rehabilitation department of Assuit university hospital during time frame of study. and apparently healthy subjects with normal electrophysiological study
Criteria

Inclusion Criteria:

  1. All adult SLE patients who was admitted to Rheumatology & Rehabilitation department of Assuit university hospital during time frame of study.
  2. apparently healthy subjects with normal electrophysiological study
  3. verbal consent, free and informed

Exclusion Criteria:

  • • Other causes of peripheral neuropathy:

    1. Traumatic
    2. Purely degenerative
    3. Diabetic
    4. Toxic
    5. Infections
    6. Drug induced

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): NCT04527172


Locations
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Egypt
Assuit university hospital
Assiut, Egypt, 12222
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Tayseer Khedr, PHD Assiut University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amira M elSonbaty, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04527172    
Other Study ID Numbers: 17200346
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: the priciple investigator only will know the results of neurophysiology done to the patients then the images were furtherly evaluated (offline) by another expert rheumatologist who was blinded to both clinical and electrophysiological data of the patients. Any conflict in reporting was refered to a third expert rheumatologist to put the final decision.

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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 Amira M elSonbaty, Assiut University:
Neuromuscular ultrasound
SLE
Peripheral neuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Lupus Erythematosus, Systemic
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases