NCT07136441

Brief Summary

The purposes of the study are:

  1. 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. 2.To measure differences in Sciatic nerve stiffness using shear-wave elastography during two movement sequences of the lower limb neurodynamic test in control group.
  3. 3.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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

August 5, 2025

Last Update Submit

September 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    20 minutes, During a single assessment session at baseline

Study Arms (2)

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.

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.

Diagnostic Test: Lower Limb Neurodynamic Test (LLNT) with Shear Wave Elastography

Interventions

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.

Also known as: Two-Sequence Neurodynamic Testing
Group A (Low Back Pain with Sciatica)Group B (Control Group)

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • Hip joint prosthesis.
  • Professional athletes (Neto et al., 2024).
  • Skin infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

RECRUITING

Study Officials

  • Eman Ahmed Abd Elmoez, PhD

    Professor, Cairo university

    STUDY CHAIR
  • Najlaa Fathi Ewais, PhD

    Assistant Professor, Cairo university

    STUDY DIRECTOR
  • Ebtisam Abdelkareem Ali, PhD

    Lecturer, Cairo university

    STUDY DIRECTOR
  • Hatem Mohamed El-Azizi, PhD

    Professor, Cairo university

    STUDY DIRECTOR

Central Study Contacts

Manar Fawzy Mohammed Hussein, M.Sc

CONTACT

Ebtisam Abdelkareem Ali, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 22, 2025

Study Start

August 15, 2025

Primary Completion

February 15, 2026

Study Completion

February 28, 2026

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations