Peripheral NeuropathyNCT04527172
Neuromuscular Ultrasonography Utility for Detection of Peripheral Neuropathy in Systemic Lupus Erythematosus
An observational study of Peripheral Neuropathy and System; Lupus Erythematosus, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Neuropathy, System; Lupus Erythematosus
- What is being tested?
- neuromuscular ultrasound
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2018to 15 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- • Other causes of peripheral neuropathy:
- Traumatic
- Purely degenerative
- Diabetic
- Toxic
- Infections
- Drug induced
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- neuromuscular ultrasound
- Keywords
- Neuromuscular ultrasound, SLE, Peripheral neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular ultrasoundDiagnostic test
Also called nerve conduction study
ultrasound to visualize the peripheral nerves of lupus patients and to compare it with results of the raditional electrophysiological studies
| Study group | Role | What they receive |
|---|---|---|
| systemic lupus patients | Nerve conduction study and neuromuscular ultrasound for median , ulnar, tibial, peroneal and sural nerves Receives: Diagnostic Test: neuromuscular ultrasound | |
| Healthy subjects | Nerve conduction study and neuromuscular ultrasound for median , ulnar, tibial, peroneal and sural nerves Receives: Diagnostic Test: neuromuscular ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6months
Describing the patterns of peripheral nerve affection in SLE patient
Evaluating different studied nerves clinically, electrophyiologically and by neuromuscular ultrasonography
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start20 May 2018
- Primary completion28 May 2019
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira M elSonbaty, Assiut University
- Investigators
- Tayseer Khedr, PHD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527172
- Sponsor's protocol ID
- 17200346
- Status last verified
- Aug 2020
- First submitted
- 22 Aug 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 34312211
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Ultrasonography Utility for Detection of Peripheral Neuropathy in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT04527172
- Acronym / sponsor ID
- 17200346
- Conditions
- Peripheral Neuropathy, System; Lupus Erythematosus
- Keywords
- Neuromuscular ultrasound, SLE, Peripheral neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 May 2018 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| systemic lupus patients | – | Diagnostic Test: neuromuscular ultrasoundNerve conduction study and neuromuscular ultrasound for median , ulnar, tibial, peroneal and sural nerves |
| Healthy subjects | – | Diagnostic Test: neuromuscular ultrasoundNerve conduction study and neuromuscular ultrasound for median , ulnar, tibial, peroneal and sural nerves |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- • Other causes of peripheral neuropathy:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuromuscular ultrasoundAlso: nerve conduction studyultrasound to visualize the peripheral nerves of lupus patients and to compare it with results of the raditional electrophysiological studies | Diagnostic test | Healthy subjects, systemic lupus patients |
Primary outcome
evaluate the rule of NMUS in detection of peripheral neuropathy in SLE patient
Time frame: 6months
Measuring sensitivity and specificity of neuromuscular ultrasound in comparison to nerve conduction study
Describing the patterns of peripheral nerve affection in SLE patient
Time frame: 6months
Evaluating different studied nerves clinically, electrophyiologically and by neuromuscular ultrasonography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Derived from this study: PubMed 34312211Mahran 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tayseer Khedr, PHD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Neuropathy and System; Lupus Erythematosus, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the rule of NMUS in detection of peripheral neuropathy in SLE patient (time frame: 6months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04527172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.