Clincosm LogoSign in Get a demo

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

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT04527172
Collaborator
(none)
55
Enrollment
1
Location
23.9
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

Study Design

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

Arms and Interventions

Arm 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 Names:
  • 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 Names:
  • nerve conduction study

    		•

    Outcome Measures

    Primary Outcome Measures

    1. evaluate the rule of NMUS in detection of peripheral neuropathy in SLE patient [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 [6months]

      Evaluating different studied nerves clinically, electrophyiologically and by neuromuscular ultrasonography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assuit university hospital Assiut Egypt 12222

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: Tayseer Khedr, PHD, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amira M elSonbaty, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04527172
    Other Study ID Numbers:
    • 17200346
    First Posted:
    Aug 26, 2020
    Last Update Posted:
    Aug 28, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amira M elSonbaty, Principal Investigator, Assiut University
    Neuromuscular ultrasound
    SLE
    Peripheral neuropathy
    Additional relevant MeSH terms:
    Peripheral Nervous System Diseases
    Lupus Erythematosus, Systemic

    Study Results

    No Results Posted as of Aug 28, 2020