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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Pakistan
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dynamic Stretching Protocol
Diagnostic test: 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
Combination product: Neural Mobilization Technique Protoco
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Superior 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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