NCT06997640

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 21, 2025

Last Update Submit

May 21, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale (VAS)

    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

    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

Study Arms (2)

Dynamic Stretching Protocol

EXPERIMENTAL
Diagnostic Test: Dynamic Stretching Protocol

Neural Mobilization Technique Protocol

ACTIVE COMPARATOR
Combination Product: Neural Mobilization Technique Protoco

Interventions

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.

Dynamic Stretching 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.

Neural Mobilization Technique Protocol

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private clinic Hyderabad Sindh

Hyderābād, Sindh, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2025

First Posted

May 30, 2025

Study Start

March 1, 2025

Primary Completion

July 1, 2025

Study Completion

February 28, 2026

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations