Clinical trial NCT04527172: Neuromuscular Ultrasonography Utility for Detection of Peripheral Neuropathy in Systemic Lupus Erythematosus
Official title: Neuromuscular Ultrasonography Utility for Detection of Peripheral Neuropathy in Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Neuropathy
System; Lupus Erythematosus
Keywords: Neuromuscular ultrasound
SLE
Peripheral neuropathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 55
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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

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

Primary outcomes:
measure: evaluate the rule of NMUS in detection of peripheral neuropathy in SLE patient
timeFrame: 6months
measure: Describing the patterns of peripheral nerve affection in SLE patient
timeFrame: 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit university hospital
Study officials:
affiliation: Assiut University
name: Tayseer Khedr, PHD
role: STUDY_DIRECTOR
References:
citation: 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.