Effects of Neurodynamic Mobilization and Stretching Exercises for Chronic Discogenic Sciatica (NDM)
Primary Purpose
Physical Therapy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Slider, tensioner neurodynamic mobilization techniques and stretching exercises of back, hamstrings and gastrocnemius
Sponsored by
About this trial
This is an interventional treatment trial for Physical Therapy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Haytham Ibrahim Morsi
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Slider neurodynamic mobilization technique only
Tensioner neurodynamic mobilization technique only
Stretching exercises of back extensors, hamstrings and gastrocnemius muscles
Arm Description
a neurodynamic mobilization technique of the sciatic nerve with stretch on one nerve end and slackness on the other end.
a neurodynamic mobilization technique of the sciatic nerve with stretch of both nerve ends.
Stretching exercises of back extensors, hamstrings and gastrocnemius to relief the pressure on the nerve.
Outcomes
Primary Outcome Measures
Change in pain intensity measurements using visual analogue scale
A scale form 0 to 10 points, a less score means improvement.
Change in hip flexion range of motion measurement using universal goniometer.
the therapist measures it for patients, an increasing value means improvement.
Change in knee extension range of motion measurement using universal goniometer.
the therapist measures it for patients, an increasing value means improvement.
Change in ankle dorsiflexion range of motion measurement using universal goniometer.
the therapist measures it for patients, an increasing value means improvement.
Change in lumbar flexion range of motion measurement using universal goniometer.
the therapist measures it for patients, an increasing value means improvement.
Change in functional disability measurement using the oswestry disability index.
An index indicating disability level, a less score indicates improvement.
Secondary Outcome Measures
Full Information
NCT ID
NCT04746690
First Posted
January 31, 2021
Last Updated
April 27, 2023
Sponsor
Cairo University
Collaborators
Kafrelsheikh University
1. Study Identification
Unique Protocol Identification Number
NCT04746690
Brief Title
Effects of Neurodynamic Mobilization and Stretching Exercises for Chronic Discogenic Sciatica
Acronym
NDM
Official Title
Effects of Slider, Tensioner Neurodynamic Mobilization Techniques and Stretching Exercises in Treatment of Chronic Discogenic Sciatica: A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Kafrelsheikh University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study compares between neurodynamic mobilization and stretching exercises in treatment of chronic dicogenic sciatica
Detailed Description
This study was conducted at the outpatient clinics, faculty of physical Therapy, Kafrelsheikh University to compare between the effects of slider, tensioner neurodynamic mobilization techniques and stretching exercises on pain, Range of motion (ROM) and functional disability for patients with chronic discogenic sciatica.
Design of the study:
A pre-test post-test three-armed comparative study design was used for comparison between the effects of slider, tensioner neurodynamic mobilization techniques and stretching exercises for patients with chronic discogenic sciatica.
Selection of patients:
Sample size:
Using G-power software program and regarding F test study , alpha level of 0.05, confidence interval 95% and effect size of 0.25 (to detect small effects ), three groups and 6 dependent variables, the total sample size will be 36 patient (twelve in each group).
To reach the specific sample size, forty-three patients were screened regarding the inclusion/exclusion criteria. Thirty-six patient with unilateral chronic discogenic sciatica from both sexes (….male and … female) were recruited from the outpatient clinics, faculty of physical Therapy, Kafrelsheikh University. Their age ranged between 21-50 years.
They were randomly allocated by simple random method; to avoid selection bias, patients were asked to choose a card of three wrapped cards representing the three treatment groups:
Group (A): received Slider technique only. Group (B): received Tensioner technique only. Group (C): received Stretching exercises of back extensors, hamstrings and gastrocnemius muscles only.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
simple random sampling
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Slider neurodynamic mobilization technique only
Arm Type
Active Comparator
Arm Description
a neurodynamic mobilization technique of the sciatic nerve with stretch on one nerve end and slackness on the other end.
Arm Title
Tensioner neurodynamic mobilization technique only
Arm Type
Active Comparator
Arm Description
a neurodynamic mobilization technique of the sciatic nerve with stretch of both nerve ends.
Arm Title
Stretching exercises of back extensors, hamstrings and gastrocnemius muscles
Arm Type
Active Comparator
Arm Description
Stretching exercises of back extensors, hamstrings and gastrocnemius to relief the pressure on the nerve.
Intervention Type
Other
Intervention Name(s)
Slider, tensioner neurodynamic mobilization techniques and stretching exercises of back, hamstrings and gastrocnemius
Other Intervention Name(s)
sliders, tensioners and stretching exercise
Intervention Description
neurodynamic mobilization techniques of sciatic nerve and stretching exercises of back extensors, hamstrings and lower limbs for patients with chronic discogenic sciatica.
Primary Outcome Measure Information:
Title
Change in pain intensity measurements using visual analogue scale
Description
A scale form 0 to 10 points, a less score means improvement.
Time Frame
Before treatment and after 2 weeks of treatment.
Title
Change in hip flexion range of motion measurement using universal goniometer.
Description
the therapist measures it for patients, an increasing value means improvement.
Time Frame
Before treatment and after 2 weeks of treatment.
Title
Change in knee extension range of motion measurement using universal goniometer.
Description
the therapist measures it for patients, an increasing value means improvement.
Time Frame
Before treatment and after 2 weeks of treatment.
Title
Change in ankle dorsiflexion range of motion measurement using universal goniometer.
Description
the therapist measures it for patients, an increasing value means improvement.
Time Frame
Before treatment and after 2 weeks of treatment.
Title
Change in lumbar flexion range of motion measurement using universal goniometer.
Description
the therapist measures it for patients, an increasing value means improvement.
Time Frame
Before treatment and after 2 weeks of treatment.
Title
Change in functional disability measurement using the oswestry disability index.
Description
An index indicating disability level, a less score indicates improvement.
Time Frame
Before treatment and after 2 weeks of treatment.
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Identity card
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bassem El-nahass, Professor
Organizational Affiliation
Professor of Orthopaedic Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haytham Ibrahim Morsi
City
Giza
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No availability of participant data
Learn more about this trial
Effects of Neurodynamic Mobilization and Stretching Exercises for Chronic Discogenic Sciatica
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