NCT04746690

Brief Summary

This study compares between neurodynamic mobilization and stretching exercises in treatment of chronic dicogenic sciatica

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

January 31, 2021

Last Update Submit

April 27, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • Change in pain intensity measurements using visual analogue scale

    A scale form 0 to 10 points, a less score means improvement.

    Before treatment and after 2 weeks of treatment.

  • Change in hip flexion range of motion measurement using universal goniometer.

    the therapist measures it for patients, an increasing value means improvement.

    Before treatment and after 2 weeks of treatment.

  • Change in knee extension range of motion measurement using universal goniometer.

    the therapist measures it for patients, an increasing value means improvement.

    Before treatment and after 2 weeks of treatment.

  • Change in ankle dorsiflexion range of motion measurement using universal goniometer.

    the therapist measures it for patients, an increasing value means improvement.

    Before treatment and after 2 weeks of treatment.

  • Change in lumbar flexion range of motion measurement using universal goniometer.

    the therapist measures it for patients, an increasing value means improvement.

    Before treatment and after 2 weeks of treatment.

  • Change in functional disability measurement using the oswestry disability index.

    An index indicating disability level, a less score indicates improvement.

    Before treatment and after 2 weeks of treatment.

Study Arms (3)

Slider neurodynamic mobilization technique only

ACTIVE COMPARATOR

a neurodynamic mobilization technique of the sciatic nerve with stretch on one nerve end and slackness on the other end.

Other: Slider, tensioner neurodynamic mobilization techniques and stretching exercises of back, hamstrings and gastrocnemius

Tensioner neurodynamic mobilization technique only

ACTIVE COMPARATOR

a neurodynamic mobilization technique of the sciatic nerve with stretch of both nerve ends.

Other: Slider, tensioner neurodynamic mobilization techniques and stretching exercises of back, hamstrings and gastrocnemius

Stretching exercises of back extensors, hamstrings and gastrocnemius muscles

ACTIVE COMPARATOR

Stretching exercises of back extensors, hamstrings and gastrocnemius to relief the pressure on the nerve.

Other: Slider, tensioner neurodynamic mobilization techniques and stretching exercises of back, hamstrings and gastrocnemius

Interventions

neurodynamic mobilization techniques of sciatic nerve and stretching exercises of back extensors, hamstrings and lower limbs for patients with chronic discogenic sciatica.

Also known as: sliders, tensioners and stretching exercise
Slider neurodynamic mobilization technique onlyStretching exercises of back extensors, hamstrings and gastrocnemius musclesTensioner neurodynamic mobilization technique only

Eligibility Criteria

Age21 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsIdentity card
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients diagnosed by magnetic resonance imaging (MRI) confirming disc lesion.
  • Radicular pain for at least twelve weeks up to one year with no acute episodes for the last four weeks.
  • Positive slump test, with reproduction of neurological symptoms.
  • Ages of 21-50 years of both sexes.
  • Patients with functional disabilities e.g. during lifting or walking

You may not qualify if:

  • Patients with sciatica due to other pathologies e.g. lumbar canal stenosis or piriformis syndrome.
  • Patients after any spinal surgery e.g. unilateral hemilaminectomy or microdiscectomy
  • Negative slump test.
  • Progressive neurological symptoms e.g. hyperirritable and unstable symptoms.
  • History of vertebral fracture or trauma.
  • Systemic disorder e.g. diabetes mellitus.
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haytham Ibrahim Morsi

Giza, Egypt

Location

Study Officials

  • Bassem El-nahass, Professor

    Professor of Orthopaedic Physical Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: simple random sampling
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 31, 2021

First Posted

February 10, 2021

Study Start

September 1, 2020

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

April 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

No availability of participant data

Locations