Augmented Posterior Oblique Sling Activation on Lumbopelvic Recruitment Pattern in Lumbosacral Radiculopathy

August 27, 2024 updated by: Hend Refaat Kamal, Cairo University

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.

Study Overview

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Giza, Egypt
        • Faculty of Physical Therapy Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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