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

NCT ID: NCT04527172

Last Updated: 2020-08-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-20
• Study Completion Date: 2020-05-15

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.

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

Conditions

Peripheral Neuropathy; System; Lupus Erythematosus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

systemic lupus patients

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

neuromuscular ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Healthy subjects

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

neuromuscular ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

neuromuscular ultrasound

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

nerve conduction study

Eligibility 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

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Amira M elSonbaty

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tayseer Khedr, PHD

Role: STUDY_DIRECTOR

Assiut University

Locations

Assuit university hospital

Asyut, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 34312211 (View on PubMed)

Other Identifiers

17200346

Identifier Type: -

Identifier Source: org_study_id