NCT05907356

Brief Summary

Neural mobilization is a technique that plays an important role in repairing the neural tissue's ability to respond to stress or tension by triggering the reconstruction of normal physiological functioning, pain reduction, and functional improvement. The study aims to examine the effect of the sciatic nerve slider technique in different positions and which of the most common positions is more effective in the application of neural mobilization in low back pain with sciatica.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2023

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

May 28, 2023

Last Update Submit

August 23, 2024

Conditions

Keywords

low back painNeuromobilizationSciatic nerve Slider techniquePositions

Outcome Measures

Primary Outcomes (5)

  • Numeric Pain Rating Scale (NPRS)

    A numeric pain rating scale (NPRS) will be used to evaluate pain intensity. The scale has a length of 10 cm and a range of 0-10, Here, a score of zero (zero) denotes the absence of pain, a score of one to three (1-3) denotes mild pain, a score of three to five (moderate pain), and a score of six to ten (severe pain)

    4 weeks

  • Oswestry Disability Index (ODI)

    The disability caused by low back pain will be measured via the Arabic version of the Oswestry Disability Index. The patient will fill out the questionnaire in about 5 minutes, and then the therapist will score it in about 1 minute. The patient marks the most relevant answer for each question as accurately as they can. The scoring system employs a numerical scale from 0 to 5, with the first possible answer being 0 and the last possible answer being 5. The maximum possible score for each section is 5. All the scores will be added together and divided by the total number of possible points to calculate the total score

    4 weeks

  • Modified Schober test

    Lumbar flexion flexibility will be measured by the modified Schober test. The patient will be standing, and the examiner will mark the L5 spinous process by drawing a horizontal line across the patient's back. A second line is marked 10 cm above the first line. The patient is then instructed to flex forward as if attempting to touch his/her toes, and the examiner remeasures the distance between two lines with the patient fully flexed. The difference between the measurements in the erect and flexion positions indicates the outcome of the lumbar flexion.

    4 weeks

  • Hand-held dynamometry

    The hand-held dynamometer has good to excellent reliability and validity for most measures of muscle strength, it portable device that is an appropriate and convenient method to assess lower limb muscle strength. to Assessment of isometric muscle strength and power will be performed with the participants in three positions (seated, supine, and prone); hip flexors, knee extensors, and knee flexors were assessed in a seated position; ankle plantar flexors, ankle dorsiflexors, hip abductors, and hip adductors in a supine position; hip extensors in a prone position

    4 weeks

  • Flexible ruler

    The lumbar lordosis will be measured by a flexible ruler. It is commonly used to measure the degree of spinal curvature of the lumbar lordosis in the sagittal plane. It is a safe, easy-to-use, and inexpensive tool.

    4 weeks

Study Arms (3)

Study Group One

EXPERIMENTAL

sciatic nerve slider technique in a slump lying position in combination with Conventional physiotherapy

Other: sciatic nerve slider technique in slump lying positionOther: Conventional physiotherapy

Study Group Two

EXPERIMENTAL

sciatic nerve slider technique in a supine position in combination with Conventional physiotherapy

Other: sciatic nerve slider technique in supine positionOther: Conventional physiotherapy

Control Group

EXPERIMENTAL

Conventional physiotherapy alone

Other: Conventional physiotherapy

Interventions

The patient will be sitting at the edge of the couch with the posterior aspect of the knee at the edge, the thighs parallel to each other, and flexion at the thoracic and lumbar spines (slouch position). The therapist will be standing at the bedside of the patient with a proximal arm over the patient's shoulder and one hand guiding the neck movements of the patient and the other hand guiding the knee movements, passively performing cervical neck flexion with knee flexion (stretching the nerve proximally and relaxing at the distal end) and then moving into cervical extension with knee extension. Provide five sets in every session: the first: 10 repetitions, the second: 15 repetitions, the third: 20 repetitions, the fourth: 25 repetitions; and the fifth: 30 repetitions. The end position is held for 5 seconds, and the rest between sets is 1-2 minutes

Study Group One

.The patient will be in a supine position. The therapist will hold the patient's limb passively and then move the hip into flexion with the ankle in plantar flexion and the knee in extension, stretching the nerve at the hip and relaxing at the ankle, Then reversing the movement with the hip into extension, maintaining the knee in extension and the ankle in dorsiflexion, relaxing the nerve at the hip and stretching at the ankle. Provide five sets in every session; the first: 10 repetitions, the second: 15 repetitions, the third: 20 repetitions, the fourth: 25 repetitions, and the fifth: 30 repetitions. The end position is held for 5 seconds, and the rest between sets is 1-2 minutes.

Study Group Two

The patient will receive conventional physiotherapy, which includes: a moist hot pack, TENS, and back strengthening exercises (as a home program).

Control GroupStudy Group OneStudy Group Two

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age range between 40 - 65 years,
  • Both genders,
  • Diagnosed by magnetic resonance imaging to confirm disc lesion,
  • LBP with radicular pain for more than 12 weeks up to 1 year with no acute episodes in the last 4 weeks, and a numeric pain rating score (NPRS) greater than 4/10.
  • Positive SLR test with reproduction of neurological symptoms.

You may not qualify if:

  • Sciatica due to other pathologies (e.g. lumbar canal stenosis or piriformis syndrome),
  • Having any physiotherapy before 6 months.
  • History of spinal surgery
  • Vertebral fracture or trauma,
  • Negative SLR test,
  • pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Alia Governmental Hospital

Hebron, West Bank, Palestinian Territories

Location

MeSH Terms

Conditions

Low Back PainSciatica

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgia

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Beliz Belgen Kaygisiz, PT, PhD

    European University of Lefke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2023

First Posted

June 18, 2023

Study Start

April 1, 2023

Primary Completion

November 20, 2023

Study Completion

December 25, 2023

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations