- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06558383
Augmented Posterior Oblique Sling Activation on Lumbopelvic Recruitment Pattern in Lumbosacral Radiculopathy
Augmented Posterior Oblique Sling Activation on Lumbopelvic Recruitment Pattern and Functional Outcomes in Lumbosacral Radiculopathy Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt
- Faculty of Physical Therapy Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ranges from 25 to 40
- L4/5 and L5/S1 disc herniation.
- Duration of pain will be more than three months.
- Normal body mass index (18.5 - 24.99Kg/m2)
Exclusion Criteria:
1. Red flags: spinal tumors, cauda equina syndrome, spinal fractures, osteoporosis, infection.
2. Bilateral symptoms. 3. Spondylolisthesis, spondylitis, and spinal canal stenosis. 4. Previous lumbopelvic or hip surgery or injection 5. Any hip structural abnormality such as malformations, impingements and degeneration.
6. Postural deviations such as scoliosis, kyphosis, lateral shift. 7. True leg length discrepancy. 8. Pregnancy and Gynecological problems.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group -
Control group (A): Twenty patients will receive selected physical therapy program for 18 sessions, three sessions per week for six weeks in form hot packs, soft tissue techniques, mobilization and manipulation of lumbar spine, and neurodynamics. |
selected physical therapy program for 18 sessions, three sessions per week for six weeks in form hot packs, soft tissue techniques, mobilization and manipulation of lumbar spine, and neurodynamics and stabilization exercises
|
|
Active Comparator: study group
Study group (B): Twenty patients will receive augmented activation of posterior oblique sling in addition to selected physical therapy program, 18 sessions, three sessions per week for six week |
selected physical therapy program for 18 sessions, three sessions per week for six weeks in form hot packs, soft tissue techniques, mobilization and manipulation of lumbar spine, and neurodynamics and stabilization exercises
activation of posterior oblique sling for 18 sessions, three sessions per week for six weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
surface EMG unit
Time Frame: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
|
The electromyographic pattern of activation of lumbopelvic musculature (sequence and level of activity) will be measured during prone hip extension testing using surface EMG unit.
|
measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
|
|
Pressure biofeedback unit
Time Frame: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
|
it will be used to assess pelvic motion.
the pressure sensor of the pressure biofeedback unit will be placed anteriorly between the patients' ilium and the testing table.
The amount of pressure applied by the patient on the sensor at rest will be recorded then, the amount of pressure applied by patients at prone hip extension at 10 degrees will be recorded.
|
measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pressure algometry
Time Frame: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
|
The pressure algometry will used to measure pressure pain threshold in low back area and in sciatic valleix.
|
measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
|
|
Arabic version of Oswestry Low Back Pain Disability Questionnaire
Time Frame: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
|
back pain-related disability will be assessed using using the Arabic version of Oswestry Low Back Pain Disability Questionnaire.It is a 10-item self-reported questionnaire.
The patient will be asked to answer every question and mark only the box that most closely describes his problem.
Each question will be assessed on a six-point scale ranging from 0 (no disability) to 5 (major disability).
The score is determined by adding each item score together.
The overall score is out of 50 .
Higher scores represent greater disability.
|
measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
|
|
back pain intensity using the Visual analogue scale
Time Frame: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
|
The subject will be asked to make a handwritten mark on a 100 mm line (10cm).
This line represents a continuum between no pain or discomfort (zero), and the worst pain (10) the patient could feel.
Measurements from the starting point of the scale to the patients' marks will be recorded and interpreted as their pain intensity.
Higher scores represent greater pain.
|
measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hoda M Zakaria, professor, Cairo University
- Study Chair: Ebtesam M Fahmy, professor, Cairo University
- Study Chair: Nagwa M Ibrahim, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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.REC/012/005233
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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