Lumbosacral RadiculopathyNCT06558383
Augmented Posterior Oblique Sling Activation on Lumbopelvic Recruitment Pattern in Lumbosacral Radiculopathy
A study testing augmented posterior oblique sling activation and selected physical therapy program in people with Lumbosacral Radiculopathy, run by Cairo University at 1 site in Egypt.
Trial summary
The current study aims to determine the impact of augmented posterior oblique sling activation on lumbopelvic recruitment pattern and functional outcomes in patients with unilateral lumbosacral radiculopathy. Read more about this study
- Who is it for?
- Ages 30 to 46 years, women only
- Conditions the study is for
- Lumbosacral Radiculopathy
- What is being tested?
- augmented posterior oblique sling activation and selected physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 20 Oct 2025
- 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 30 to 46 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age ranges from 30 to 46
- L5/S1 disc herniation.
- Duration of pain is more than three months.
- body mass index less than 30 kg/cm2
- ability to perform prone hip extension task with no pain
- impaired lumbopelvic stability (<5 mmHg pressure difference from baseline to end prone hip extension task)
- moderate to severe lumbosacral radicular pain
Who cannot join
- Red flags: spinal tumors, cauda equina syndrome, spinal fractures, osteoporosis, infection.
- Bilateral symptoms.
- Spondylolisthesis, spondylitis, and spinal canal stenosis.
- Previous lumbopelvic or hip surgery or injection
- Any hip structural abnormality such as malformations, impingements and degeneration.
- Postural deviations such as scoliosis, kyphosis, lateral shift.
- True leg length discrepancy.
- Pregnancy and Gynecological problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Augmented Posterior Oblique Sling Activation on Lumbopelvic Recruitment Pattern and Functional Outcomes in Lumbosacral Radiculopathy Patients
The current study aims to determine the impact of augmented posterior oblique sling activation on lumbopelvic recruitment pattern and functional outcomes in patients with unilateral lumbosacral radiculopathy.
Read the detailed description
Low back pain is now the leading cause of disability worldwide. Back pain and its related disability have a huge impact on individuals, communities, and healthcare systems. It reduces an individual's ability to participate in work which in turn negatively affects their quality of life. Also, it has major economic consequences through increasing the cost of health care and work absenteeism. Among the many differentials of low back pain, the most common cause is lumbosacral radiculopathy. Patients with low back pain showed uncontrolled lumbopelvic mobility while performing hip extension movement in functional activities. In patients with back pain, there is over-activation of the hamstrings and erector spinae and delayed or absent contraction of the gluteus maximus. Clinically, this pattern is observed as an anterior pelvic tilt with increased extension in the lumbar spine as the patient lifts the leg into extension. So, repetition of this abnormal pattern in patients with lumbosacral radiculopathy may result in mechanical and compressive stresses in the lumbar spine and magnify the patient's symptoms. Despite the role of POSM in improving spinal mobility and stability. And stabilizing the lumbopelvic joint, there are no previous studies investigating the impact of activation posterior oblique activation on this abnormal lumbopelvic recruitment and functional outcomes in patients with lumbosacral radiculopathy.
- Conditions
- Lumbosacral Radiculopathy
- Being tested
- augmented posterior oblique sling activation, selected physical therapy program
- Keywords
- posterior oblique sling, recruitment pattern, lumbar radiculopathy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
augmented posterior oblique sling activationOther
activation of posterior oblique sling program for 18 sessions, three sessions per week for six weeks in the form of:
- drop and catch technique
- modified prone hip extension exercises
- trunk and leg dissociation task
selected physical therapy programOther
selected physical therapy program for 18 sessions, three sessions per week for six weeks in form of soft tissue techniques, mobilization and manipulation of lumbar spine, and neurodynamics and stabilization exercises
| Study group | Role | What they receive |
|---|---|---|
| control group - | Active comparator | Control group (A):
Twenty patients will receive selected physical therapy program for 18 sessions, three sessions per week for six weeks in form of soft tissue techniques, mobilization and manipulation of lumbar spine, and neurodynamics. Receives: Other: selected physical therapy program |
| study group | Active comparator | 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 Receives: Other: augmented posterior oblique sling activation; Other: selected physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
surface EMG unit
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.
Measured: 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
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.
Measured: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Secondary outcomes (3)
pressure algometry
The pressure algometry will used to measure pressure pain threshold in low back area and in sciatic valleix.
Measured: 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
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.
Measured: 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
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.
Measured: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Sep 2024
- Primary completion20 Sep 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral RadiculopathyStudies 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
- Randomized controlled trial. True experimental research design study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Refaat Kamal, Cairo University
- Investigators
- Hoda M Zakaria, professor, Study chair, Cairo UniversityEbtesam M Fahmy, professor, Study chair, Cairo UniversityNagwa M Ibrahim, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558383
- Sponsor's protocol ID
- P.T.REC/012/005233
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Posterior Oblique Sling Activation on Lumbopelvic Recruitment Pattern and Functional Outcomes in Lumbosacral Radiculopathy Patients
- ClinicalTrials.gov ID
- NCT06558383
- Acronym / sponsor ID
- P.T.REC/012/005233
- Conditions
- Lumbosacral Radiculopathy
- Keywords
- posterior oblique sling, recruitment pattern, lumbar radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 16 Aug 2024 (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.
The current study aims to determine the impact of augmented posterior oblique sling activation on lumbopelvic recruitment pattern and functional outcomes in patients with unilateral lumbosacral radiculopathy.
Detailed description
Low back pain is now the leading cause of disability worldwide. Back pain and its related disability have a huge impact on individuals, communities, and healthcare systems. It reduces an individual's ability to participate in work which in turn negatively affects their quality of life. Also, it has major economic consequences through increasing the cost of health care and work absenteeism. Among the many differentials of low back pain, the most common cause is lumbosacral radiculopathy. Patients with low back pain showed uncontrolled lumbopelvic mobility while performing hip extension movement in functional activities. In patients with back pain, there is over-activation of the hamstrings and erector spinae and delayed or absent contraction of the gluteus maximus. Clinically, this pattern is observed as an anterior pelvic tilt with increased extension in the lumbar spine as the patient lifts the leg into extension. So, repetition of this abnormal pattern in patients with lumbosacral radiculopathy may result in mechanical and compressive stresses in the lumbar spine and magnify the patient's symptoms. Despite the role of POSM in improving spinal mobility and stability. And stabilizing the lumbopelvic joint, there are no previous studies investigating the impact of activation posterior oblique activation on this abnormal lumbopelvic recruitment and functional outcomes in patients with lumbosacral radiculopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial. True experimental research design study
| Arm | Type | Receives |
|---|---|---|
| control group - | Active comparator | Other: selected physical therapy programControl group (A): Twenty patients will receive selected physical therapy program for 18 sessions, three sessions per week for six weeks in form of soft tissue techniques, mobilization and manipulation of lumbar spine, and neurodynamics. |
| study group | Active comparator | Other: augmented posterior oblique sling activation, Other: selected physical therapy programStudy 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 |
Who may qualify
- Ages
- 30 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age ranges from 30 to 46
- L5/S1 disc herniation.
- Duration of pain is more than three months.
- body mass index less than 30 kg/cm2
- ability to perform prone hip extension task with no pain
Key exclusion criteria (8 listed)
- Red flags: spinal tumors, cauda equina syndrome, spinal fractures, osteoporosis, infection.
- Bilateral symptoms.
- Spondylolisthesis, spondylitis, and spinal canal stenosis.
- Previous lumbopelvic or hip surgery or injection
- Any hip structural abnormality such as malformations, impingements and degeneration.
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 |
|---|---|---|
| augmented posterior oblique sling activationactivation of posterior oblique sling program for 18 sessions, three sessions per week for six weeks in the form of: * drop and catch technique * modified prone hip extension exercises * trunk and leg dissociation task | Other | study group |
| selected physical therapy programselected physical therapy program for 18 sessions, three sessions per week for six weeks in form of soft tissue techniques, mobilization and manipulation of lumbar spine, and neurodynamics and stabilization exercises | Other | control group -, study group |
Primary outcome
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.
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.
3 secondary outcomes
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
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 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
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 16 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Hoda M Zakaria, professor study chair
Cairo University
Ebtesam M Fahmy, professor study chair
Cairo University
Nagwa M Ibrahim study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing augmented posterior oblique sling activation and selected physical therapy program in people with Lumbosacral Radiculopathy, 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 7 inclusion and 8 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 16 Sep 2026. 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?
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 study lists 2 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 16 Sep 2026.