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

NCT04527172 | Completed

• 1 other identifier: 17200346
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathy; System; Lupus Erythematosus

Keywords

Neuromuscular ultrasound; SLE; Peripheral neuropathy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

systemic lupus patients

Nerve conduction study and neuromuscular ultrasound for median , ulnar, tibial, peroneal and sural nerves

Diagnostic Test: neuromuscular ultrasound

Healthy subjects

Nerve conduction study and neuromuscular ultrasound for median , ulnar, tibial, peroneal and sural nerves

Diagnostic Test: neuromuscular ultrasound

Interventions

neuromuscular ultrasound DIAGNOSTIC_TEST

ultrasound to visualize the peripheral nerves of lupus patients and to compare it with results of the raditional electrophysiological studies

Also known as: nerve conduction study

Healthy subjects; systemic lupus patients

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Other causes of peripheral neuropathy:
• Traumatic
• Purely degenerative
• Diabetic
• Toxic
• Infections
• Drug induced

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit university hospital

Asyut, 12222, Egypt

Location

Related Publications (1)

• 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.

  PMID: 34312211 DERIVED

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Lupus Erythematosus, Systemic

Interventions

Nerve Conduction Studies

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Tayseer Khedr, PHD

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2020
• First Posted: August 26, 2020
• Study Start: May 20, 2018
• Primary Completion: May 28, 2019
• Study Completion: May 15, 2020
• Last Updated: August 28, 2020

Record last verified: 2020-08

Locations

EG (1)