- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06997640
- Original Trial
Comparative Analysis of DS and NMT on Pelvic Inclination in Early Middle-Aged Patients With Radicular Low Back Pain
May 21, 2025 updated by: Muhammad Naveed Babur, Superior University
Comparative Analysis of Dynamic Stretching and Neural Mobilization Techniques on Pelvic Inclination in Early Middle-Aged Patients With Radicular Low Back Pain
Radicular low back pain (RLBP) is a common and debilitating condition characterized by nerve root irritation or compression, often resulting in altered biomechanics, muscular imbalances, and postural deviations such as anterior pelvic tilt.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Rehabilitation strategies commonly focus on improving flexibility, neuromuscular control, and nerve mobility.
Among these, dynamic stretching and neural mobilization techniques have shown individual effectiveness, but limited evidence exists on their comparative or combined effects on pelvic alignment and functional outcomes, particularly in early middle-aged adults.
Addressing this gap could support the development of more targeted, evidence-based rehabilitation protocols.
Study Type
Interventional
Enrollment (Actual)
30
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
-
-
Sindh
-
Hyderabad, Sindh, Pakistan
- Private clinic Hyderabad Sindh
-
-
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
Yes
Description
Inclusion Criteria:
- Both Male and Female
- Early middle-aged adults (aged 35-55 years)
- Diagnosed with radicular low back pain (RLBP) lasting more than 4 weeks
- Positive Straight Leg Raise (SLR) or Slump test
- Able to participate in physical therapy sessions 3 times/week(26)
Exclusion Criteria:
- History of spinal surgery or fractures
- Severe neurological deficits (e.g., foot drop, bladder/bowel dysfunction)
- Diagnosed with inflammatory or systemic conditions (e.g., ankylosing spondylitis, rheumatoid arthritis)
- Concurrent participation in other physical therapy programs
- Pregnant women or individuals with severe cardiovascular conditions
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dynamic Stretching Protocol
|
Participants assigned to Group A will undergo a structured dynamic stretching protocol, designed to enhance lumbar flexibility, core muscle activation, and postural alignment, specifically targeting the pelvic inclination associated with radicular low back pain (RLBP).
The intervention will be administered three times per week under the direct supervision of a qualified physiotherapist.
Each session will last for 30 minutes, beginning with a 5-minute warm-up involving light aerobic activity such as marching or gentle trunk rotations to prepare the body for movement.
This will be followed by 20 minutes of dynamic stretching exercises, focusing on the major muscle groups that influence pelvic and lumbar mobility.
|
|
Active Comparator: Neural Mobilization Technique Protocol
|
Participants in Group B will receive a standardized neural mobilization intervention, targeting the sciatic nerve and lumbar plexus, known to contribute to pain and restricted mobility in radicular low back pain (RLBP).
The treatment will be conducted three times per week, with each session lasting 30 minutes under the guidance of an experienced physiotherapist trained in neurodynamic techniques.
The session will begin with a 5-minute preparatory phase to position the participant comfortably and explain the sequence of movements.
This will be followed by 20 minutes of gentle neural mobilization techniques, including nerve sliders and tensioners, performed through movements such as the Straight Leg Raise (SLR) sliders and the Seated Slump mobilization technique.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: 12 Months
|
The Visual Analog Scale (VAS) is a subjective but highly sensitive tool used for assessing pain intensity in clinical and research settings.
It consists of a 10- centimeter horizontal line with endpoints labeled "0 = No pain" and "10 = Worst imaginable pain."
Participants will be instructed to mark a point on the line that best reflects the intensity of their current pain, both at rest and during movement.
The distance (in centimeters) from the "no pain" anchor to the marked point is then measured and recorded as the pain score.
|
12 Months
|
|
Modified Schober Test
Time Frame: 12 Months
|
It is a reliable and simple clinical method used to assess lumbar spine flexibility, particularly in the sagittal plane.
It measures the extent of lumbar flexion by quantifying the increase in distance between two anatomical landmarks during forward bending.
To perform the test, the examiner marks a point at the level of the posterior superior iliac spines (PSIS), which corresponds approximately to the L5 vertebra.
A second mark is made 10 cm above and a third mark 5 cm below the initial point.
The participant is then asked to bend forward as far as possible while keeping the knees straight.
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 1, 2025
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
February 28, 2026
Study Registration Dates
First Submitted
May 21, 2025
First Submitted That Met QC Criteria
May 21, 2025
First Posted (Actual)
May 30, 2025
Study Record Updates
Last Update Posted (Actual)
May 30, 2025
Last Update Submitted That Met QC Criteria
May 21, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSRSW/Batch-Fall23/826
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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