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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Neuropathy; System; Lupus Erythematosus
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 12222
    • Assuit University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate the rule of NMUS in detection of peripheral neuropathy in SLE patient	Measuring sensitivity and specificity of neuromuscular ultrasound in comparison to nerve conduction study	6months
Describing the patterns of peripheral nerve affection in SLE patient	Evaluating different studied nerves clinically, electrophyiologically and by neuromuscular ultrasonography	6months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Tayseer Khedr, PHD, Assiut University

Publications and helpful links

General Publications

• Mahran SA, Galluccio F, Khedr TM, Elsonbaty A, Allam AE, Garcia Martos A, Osman DMM, Matucci-Cerinic M, Guiducci S, Galal MAA. Peripheral neuropathy in systemic lupus erythematosus: what can neuromuscular ultrasonography (NMUS) tell us? A cross-sectional study. Lupus Sci Med. 2021 Jul;8(1):e000521. doi: 10.1136/lupus-2021-000521.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2018
• Primary Completion (ACTUAL): May 28, 2019
• Study Completion (ACTUAL): May 15, 2020

Study Registration Dates

• First Submitted: August 22, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (ACTUAL): August 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: SLE; Peripheral neuropathy; Neuromuscular ultrasound
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Neuromuscular Diseases; Lupus Erythematosus, Systemic; Peripheral Nervous System Diseases
• Other Study ID Numbers: 17200346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No