- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04746690
Effects of Neurodynamic Mobilization and Stretching Exercises for Chronic Discogenic Sciatica (NDM)
Effects of Slider, Tensioner Neurodynamic Mobilization Techniques and Stretching Exercises in Treatment of Chronic Discogenic Sciatica: A Comparative Study
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Haytham Morsi, B.Sc.
- Phone Number: +201013657738
- Email: 10722019485962@pg.cu.edu.eg
Study Locations
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Giza, Egypt
- Haytham Ibrahim Morsi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Slider neurodynamic mobilization technique only
a neurodynamic mobilization technique of the sciatic nerve with stretch on one nerve end and slackness on the other end.
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neurodynamic mobilization techniques of sciatic nerve and stretching exercises of back extensors, hamstrings and lower limbs for patients with chronic discogenic sciatica.
Other Names:
|
Active Comparator: Tensioner neurodynamic mobilization technique only
a neurodynamic mobilization technique of the sciatic nerve with stretch of both nerve ends.
|
neurodynamic mobilization techniques of sciatic nerve and stretching exercises of back extensors, hamstrings and lower limbs for patients with chronic discogenic sciatica.
Other Names:
|
Active Comparator: Stretching exercises of back extensors, hamstrings and gastrocnemius muscles
Stretching exercises of back extensors, hamstrings and gastrocnemius to relief the pressure on the nerve.
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neurodynamic mobilization techniques of sciatic nerve and stretching exercises of back extensors, hamstrings and lower limbs for patients with chronic discogenic sciatica.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain intensity measurements using visual analogue scale
Time Frame: Before treatment and after 2 weeks of treatment.
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A scale form 0 to 10 points, a less score means improvement.
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Before treatment and after 2 weeks of treatment.
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Change in hip flexion range of motion measurement using universal goniometer.
Time Frame: Before treatment and after 2 weeks of treatment.
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the therapist measures it for patients, an increasing value means improvement.
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Before treatment and after 2 weeks of treatment.
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Change in knee extension range of motion measurement using universal goniometer.
Time Frame: Before treatment and after 2 weeks of treatment.
|
the therapist measures it for patients, an increasing value means improvement.
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Before treatment and after 2 weeks of treatment.
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Change in ankle dorsiflexion range of motion measurement using universal goniometer.
Time Frame: Before treatment and after 2 weeks of treatment.
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the therapist measures it for patients, an increasing value means improvement.
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Before treatment and after 2 weeks of treatment.
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Change in lumbar flexion range of motion measurement using universal goniometer.
Time Frame: Before treatment and after 2 weeks of treatment.
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the therapist measures it for patients, an increasing value means improvement.
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Before treatment and after 2 weeks of treatment.
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Change in functional disability measurement using the oswestry disability index.
Time Frame: Before treatment and after 2 weeks of treatment.
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An index indicating disability level, a less score indicates improvement.
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Before treatment and after 2 weeks of treatment.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bassem El-nahass, Professor, Professor of Orthopaedic Physical Therapy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.8/8/93
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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