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

Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04527172
• Other study ID #: 17200346
• Status: Completed
• Start date: May 20, 2018
• Est. completion date: May 15, 2020

Study information

• Verified date: August 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 15, 2020
• Est. primary completion date: May 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• System; Lupus Erythematosus

Intervention

Diagnostic Test:
• neuromuscular ultrasound
ultrasound to visualize the peripheral nerves of lupus patients and to compare it with results of the raditional electrophysiological studies

Locations

Country	Name	City	State
Egypt	Assuit university hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Describing the patterns of peripheral nerve affection in SLE patient	Evaluating different studied nerves clinically, electrophyiologically and by neuromuscular ultrasonography	6months