Sciatic NerveNCT07136441
Sciatic Nerve Stiffness Using Two-Sequences of Lower Limb Neurodynamic Testing: A Shear Wave Elastography Study
An observational study of Sciatic Nerve, run by Cairo University at 1 site in Egypt.
Trial summary
The purposes of the study are: 1. To measure differences in Sciatic nerve (SN) stiffness using shear-wave elastography (SWE) during two movement sequences of the lower limb neurodynamic test (LLNT) in low back pain with sciatica. 2. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sciatic Nerve
- What is being tested?
- Lower Limb Neurodynamic Test (LLNT) with Shear Wave Elastography
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Sixty subjects of both genders will be participated in this study. Their age will range between 25 to 40 years. They will receive verbal and written explanations for this study. If they decide to participate in this study, they will sign the consent form. The sample will be selected from the faculty of physical therapy outpatient clinics and at El kasr Elainy.
Who may be able to join
- Thirty participants ranging in age from 25 to 40 years from both genders with a diagnosis of low back pain with radiating leg pain and thirty control group.
- The main symptoms are low back pain with unilateral leg pain(sciatica) for 3-12 months for group A.
- Patients with lumbar disc herniation (L4-5) with diagnostic imaging as MRI for group A.
- Positive straight leg raising are considered for inclusion in the study for group A.
- Control group must be free from any symptoms of nerve irritation or compression, with normal neurological examination findings, including reflexes, sensation, negative straight leg raising and motor strength.
Who cannot join
- Diabetes mellitus.
- Any type of polyneuropathy
- Trauma of lumbar spine
- Previous history of back surgery
- Piriformis syndrome.
- Participants with conditions that reduce image quality on US imaging (thick gluteal subcutaneous fat tissue.
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- Hip joint prosthesis.
- Professional athletes (Neto et al., 2024).
- Skin infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ebtisam Abdelkareem Ali, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza
Manar Fawzy Mohammed Hussein, M.Sc, +20 120 140 8924, manar.fawzy@the.suezuni.edu.eg
About this study
The purposes of the study are:
- To measure differences in Sciatic nerve (SN) stiffness using shear-wave elastography (SWE) during two movement sequences of the lower limb neurodynamic test (LLNT) in low back pain with sciatica.
- To measure differences in Sciatic nerve stiffness using shear-wave elastography during two movement sequences of the lower limb neurodynamic test in control group.
- To compare difference in Sciatic nerve stiffness using shear-wave elastography during two movement sequences of the lower limb neurodynamic test between low back pain patients with sciatica and control group.
Read the detailed description
As peripheral nerves can exhibit regional variations in their anatomy and mechanical properties, investigating the response of different nerve segments to different loading patterns based on the order of joint movement will provide a better understanding of nerve biomechanics during neurodynamic testing.
This may help optimize the lower limb neurodynamic test (LLNT) application for different pathological situations and potentially increase its diagnostic capacity to detect localized alterations in a specific nerve segment such as sciatica.
Ultrasonography does not have the sensitivity required to detect all forms of peripheral nerve disorders and fails to provide information about nerve mechanical properties such as stiffness.
By using neurodynamic sequencing, clinicians may direct neural stress toward targeted areas suspected of involvement and, at the same time, perform the test with reduced load on more remote nerve segments. The ability to modify neural load distribution during the LLNT could play an interesting role in differential diagnosis, when symptoms present similar characteristics but have different regional origin.
There is a gap in the literature concerning the measurement of (SWV) of sciatic nerve during LLNT proximal (LLNT-PROX) to distal and from distal (LLNT_DIST) to proximal sequences of LLNT.
- Conditions
- Sciatic Nerve
- Being tested
- Lower Limb Neurodynamic Test (LLNT) with Shear Wave Elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Limb Neurodynamic Test (LLNT) with Shear Wave ElastographyDiagnostic test
Also called Two-Sequence Neurodynamic Testing
Participants underwent sciatic nerve stiffness assessment using shear wave elastography during two distinct sequences of the lower limb neurodynamic test. Each participant received:
Proximal-to-distal sequence: Starting with hip flexion, followed by knee extension, then ankle dorsiflexion with toe extension.
Distal-to-proximal sequence: Starting with ankle dorsiflexion and toe extension, followed by knee extension, then hip flexion.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Low Back Pain with Sciatica) | Thirty patients with low back pain with sciatica aged 25-40 years with unilateral leg pain for 3-12 months, lumbar disc herniation (L4-5) confirmed by MRI, and positive straight leg raising test. Participants will receive sciatic nerve tension tests using both proximal-to-distal and distal-to-proximal sequences with shear wave elastography assessment. Receives: Diagnostic Test: Lower Limb Neurodynamic Test (LLNT) with Shear Wave Elastography | |
| Group B (Control Group) | Thirty healthy control participants aged 25-40 years, free from symptoms of nerve irritation or compression, with normal neurological examination findings including normal reflexes, sensation, negative straight leg raising test, and normal motor strength. Participants will receive the same sciatic nerve tension tests in both sequences. Receives: Diagnostic Test: Lower Limb Neurodynamic Test (LLNT) with Shear Wave Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shear Wave Velocity (SWV) measured in meters per second (m/s)
Quantitative measurement of sciatic nerve stiffness during two different movement sequences of the Lower Limb Neurodynamic Test (LLNT). Higher SWV values indicate increased nerve stiffness.
Measured: 20 minutes, During a single assessment session at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start15 Aug 2025
- Primary completion15 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sciatic NerveStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Fawzy Mohamed, Cairo University
- Investigators
- Eman Ahmed Abd Elmoez, PhD, Study chair, Professor, Cairo universityNajlaa Fathi Ewais, PhD, Study director, Assistant Professor, Cairo universityEbtisam Abdelkareem Ali, PhD, Study director, Lecturer, Cairo universityHatem Mohamed El-Azizi, PhD, Study director, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136441
- Sponsor's protocol ID
- P.T.REC/012/005897
- Status last verified
- Sep 2025
- First submitted
- 5 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sciatic Nerve Stiffness Using Two-Sequences of Lower Limb Neurodynamic Testing: A Shear Wave Elastography Study
- ClinicalTrials.gov ID
- NCT07136441
- Acronym / sponsor ID
- P.T.REC/012/005897
- Conditions
- Sciatic Nerve
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 22 Aug 2025 (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.
The purposes of the study are:
- To measure differences in Sciatic nerve (SN) stiffness using shear-wave elastography (SWE) during two movement sequences of the lower limb neurodynamic test (LLNT) in low back pain with sciatica.
- To measure differences in Sciatic nerve stiffness using shear-wave elastography during two movement sequences of the lower limb neurodynamic test in control group.
- To compare difference in Sciatic nerve stiffness using shear-wave elastography during two movement sequences of the lower limb neurodynamic test between low back pain patients with sciatica and control group.
Detailed description
As peripheral nerves can exhibit regional variations in their anatomy and mechanical properties, investigating the response of different nerve segments to different loading patterns based on the order of joint movement will provide a better understanding of nerve biomechanics during neurodynamic testing.
This may help optimize the lower limb neurodynamic test (LLNT) application for different pathological situations and potentially increase its diagnostic capacity to detect localized alterations in a specific nerve segment such as sciatica.
Ultrasonography does not have the sensitivity required to detect all forms of peripheral nerve disorders and fails to provide information about nerve mechanical properties such as stiffness.
By using neurodynamic sequencing, clinicians may direct neural stress toward targeted areas suspected of involvement and, at the same time, perform the test with reduced load on more remote nerve segments. The ability to modify neural load distribution during the LLNT could play an interesting role in differential diagnosis, when symptoms present similar characteristics but have different regional origin.
There is a gap in the literature concerning the measurement of (SWV) of sciatic nerve during LLNT proximal (LLNT-PROX) to distal and from distal (LLNT_DIST) to proximal sequences of LLNT.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Low Back Pain with Sciatica) | – | Diagnostic Test: Lower Limb Neurodynamic Test (LLNT) with Shear Wave ElastographyThirty patients with low back pain with sciatica aged 25-40 years with unilateral leg pain for 3-12 months, lumbar disc herniation (L4-5) confirmed by MRI, and positive straight leg raising test. Participants will receive sciatic nerve tension tests using both proximal-to-distal and distal-to-proximal sequences with shear wave elastography assessment. |
| Group B (Control Group) | – | Diagnostic Test: Lower Limb Neurodynamic Test (LLNT) with Shear Wave ElastographyThirty healthy control participants aged 25-40 years, free from symptoms of nerve irritation or compression, with normal neurological examination findings including normal reflexes, sensation, negative straight leg raising test, and normal motor strength. Participants will receive the same sciatic nerve tension tests in both sequences. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Sixty subjects of both genders will be participated in this study. Their age will range between 25 to 40 years. They will receive verbal and written explanations for this study. If they decide to participate in this study, they will sign the consent form. The sample will be selected from the faculty of physical therapy outpatient clinics and at El kasr Elainy.
Key inclusion criteria (5 listed)
- Thirty participants ranging in age from 25 to 40 years from both genders with a diagnosis of low back pain with radiating leg pain and thirty control group.
- The main symptoms are low back pain with unilateral leg pain(sciatica) for 3-12 months for group A.
- Patients with lumbar disc herniation (L4-5) with diagnostic imaging as MRI for group A.
- Positive straight leg raising are considered for inclusion in the study for group A.
- Control group must be free from any symptoms of nerve irritation or compression, with normal neurological examination findings, including reflexes, sensation, negative straight leg raising and motor strength.
Key exclusion criteria (9 listed)
- Diabetes mellitus.
- Any type of polyneuropathy
- Trauma of lumbar spine
- Previous history of back surgery
- Piriformis syndrome.
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 |
|---|---|---|
| Lower Limb Neurodynamic Test (LLNT) with Shear Wave ElastographyAlso: Two-Sequence Neurodynamic TestingParticipants underwent sciatic nerve stiffness assessment using shear wave elastography during two distinct sequences of the lower limb neurodynamic test. Each participant received: Proximal-to-distal sequence: Starting with hip flexion, followed by knee extension, then ankle dorsiflexion with toe extension. Distal-to-proximal sequence: Starting with ankle dorsiflexion and toe extension, followed by knee extension, then hip flexion. | Diagnostic test | Group A (Low Back Pain with Sciatica), Group B (Control Group) |
Primary outcome
Shear Wave Velocity (SWV) measured in meters per second (m/s)
Time frame: 20 minutes, During a single assessment session at baseline
Quantitative measurement of sciatic nerve stiffness during two different movement sequences of the Lower Limb Neurodynamic Test (LLNT). Higher SWV values indicate increased nerve stiffness.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
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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.
Ebtisam Abdelkareem Ali, PhD contact
Eman Ahmed Abd Elmoez, PhD study chair
Professor, Cairo university
Najlaa Fathi Ewais, PhD study director
Assistant Professor, Cairo university
Ebtisam Abdelkareem Ali, PhD study director
Lecturer, Cairo 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 Sciatic Nerve, run by Cairo 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 11 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manar Fawzy Mohammed Hussein, M.Sc (+20 120 140 8924, manar.fawzy@the.suezuni.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shear Wave Velocity (SWV) measured in meters per second (m/s) (time frame: 20 minutes, During a single assessment session at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2025.