Physical TherapyNDMNCT04746690
Effects of Neurodynamic Mobilization and Stretching Exercises for Chronic Discogenic Sciatica
A study testing Slider, tensioner neurodynamic mobilization techniques and stretching exercises of back, hamstrings and gastrocnemius in people with Physical Therapy, run by Cairo University at 1 site in Egypt.
Trial summary
This study compares between neurodynamic mobilization and stretching exercises in treatment of chronic dicogenic sciatica Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Physical Therapy
- What is being tested?
- Slider, tensioner neurodynamic mobilization techniques and stretching exercises of back, hamstrings and gastrocnemius
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Slider, Tensioner Neurodynamic Mobilization Techniques and Stretching Exercises in Treatment of Chronic Discogenic Sciatica: A Comparative Study
This study compares between neurodynamic mobilization and stretching exercises in treatment of chronic dicogenic sciatica
Read the 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.
- Conditions
- Physical Therapy
- Being tested
- Slider, tensioner neurodynamic mobilization techniques and stretching exercises of back, hamstrings and gastrocnemius
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slider, tensioner neurodynamic mobilization techniques and stretching exercises of back, hamstrings and gastrocnemiusOther
Also called sliders, tensioners and stretching exercise
neurodynamic mobilization techniques of sciatic nerve and stretching exercises of back extensors, hamstrings and lower limbs for patients with chronic discogenic sciatica.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Slider, tensioner neurodynamic mobilization techniques and stretching exercises of back, hamstrings and gastrocnemius |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity measurements using visual analogue scale
A scale form 0 to 10 points, a less score means improvement.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before treatment and after 2 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Sep 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical TherapyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- simple random sampling
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Kafrelsheikh University
- Responsible party
- Principal investigator, Mona Mohamed Ibrahim, Cairo University
- Investigators
- Bassem El-nahass, Professor, Principal investigator, Professor of Orthopaedic Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746690
- Sponsor's protocol ID
- P.T.8/8/93
- Acronym
- NDM
- Status last verified
- Apr 2023
- First submitted
- 31 Jan 2021
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No availability of participant data
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Slider, Tensioner Neurodynamic Mobilization Techniques and Stretching Exercises in Treatment of Chronic Discogenic Sciatica: A Comparative Study
- ClinicalTrials.gov ID
- NCT04746690
- Acronym / sponsor ID
- NDM / P.T.8/8/93
- Conditions
- Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Kafrelsheikh University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- simple random sampling
| Arm | Type | Receives |
|---|---|---|
| Slider neurodynamic mobilization technique only | Active comparator | Other: Slider, tensioner neurodynamic mobilization techniques and stretching exercises of back, hamstrings and gastrocnemiusa neurodynamic mobilization technique of the sciatic nerve with stretch on one nerve end and slackness on the other end. |
| Tensioner neurodynamic mobilization technique only | Active comparator | Other: Slider, tensioner neurodynamic mobilization techniques and stretching exercises of back, hamstrings and gastrocnemiusa neurodynamic mobilization technique of the sciatic nerve with stretch of both nerve ends. |
| Stretching exercises of back extensors, hamstrings and gastrocnemius muscles | Active comparator | Other: Slider, tensioner neurodynamic mobilization techniques and stretching exercises of back, hamstrings and gastrocnemiusStretching exercises of back extensors, hamstrings and gastrocnemius to relief the pressure on the nerve. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slider, tensioner neurodynamic mobilization techniques and stretching exercises of back, hamstrings and gastrocnemiusAlso: sliders, tensioners and stretching exerciseneurodynamic mobilization techniques of sciatic nerve and stretching exercises of back extensors, hamstrings and lower limbs for patients with chronic discogenic sciatica. | Other | Slider neurodynamic mobilization technique only, Stretching exercises of back extensors, hamstrings and gastrocnemius muscles, Tensioner neurodynamic mobilization technique only |
Primary outcome
Change in pain intensity measurements using visual analogue scale
Time frame: Before treatment and after 2 weeks of treatment.
A scale form 0 to 10 points, a less score means improvement.
Change in hip flexion 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.
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.
Change in ankle dorsiflexion 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.
Change in lumbar flexion 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.
Change in functional disability measurement using the oswestry disability index.
Time frame: Before treatment and after 2 weeks of treatment.
An index indicating disability level, a less score indicates improvement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: No. No availability of participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bassem El-nahass, Professor principal investigator
Professor of Orthopaedic Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slider, tensioner neurodynamic mobilization techniques and stretching exercises of back, hamstrings and gastrocnemius in people with Physical Therapy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity measurements using visual analogue scale (time frame: Before treatment and after 2 weeks of treatment.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.