NCT07138300

Brief Summary

This study attempts to answer the following research question: what is the combined effect of low level laser therapy and neural mobilization on lumber disc prolapse in decreasing pain, improving functional disability, improving neural mobility and improve lumber flexion mobility?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
Last Updated

August 22, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

August 16, 2025

Last Update Submit

August 16, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • pain assessment before and after treatment

    by visual analog scale (VAS)

    4 weeks

  • Functional disability :evaluate the patient's ability to perform various activities of daily living

    by Oswestry Disability Index (ODI)

    4 weeks

  • evaluate neural mobility before and after treatment

    by Straight leg raising test (SLR) ,The range of motion of the SLR test was measured as the angle of hip flexion in relation to the horizontal

    4weeks

  • evaluate lumbar flexion mobility before and after treatment

    by Schober's test

    4weeks

  • Neurological assessment screening of neuropathic pain

    by slump test

    4 weeks

Study Arms (2)

Experimental group (B)

EXPERIMENTAL

20 patients will receive low level laser therapy plus neural mobilization. * Mobilization will be through using slump sitting maneuver (Both techniques 1. The slider neurodynamic mobilization technique: The patient moves actively and conversely from a position of neck and trunk flexion, knee flexion, and ankle plantar flexion, to a position of neck and trunk extension, knee extension and ankle dorsiflexion. 2. The tension neurodynamic mobilization technique: The patient moves actively and conversely from a position of neck and trunk extension, knee flexion, and ankle plantar flexion, to a position of neck and trunk flexion, knee extension, and ankle dorsiflexion * Low level laser therapy : Twenty points were established for treatment, 12 over the lumbar spine, at the same Side of the radicular pain, from l2 to s1 vertebra, distance between these points is 2 cm. In the thigh, eight points were marked at equal distances from each other, four in the path of l5 root and four in the path of

Device: Low Level Laser Therapy by (Eme Physio, Lasermed 2200), GaAs laser, 1 cm2 beam area,7,000 Hz, 17 mW, 1 J/cm2, Pesaro, Italy)Procedure: neural mobilization

control group (A)

ACTIVE COMPARATOR

20 will receive placebo laser therapy plus neural mobilization. Mobilization will be through using slump sitting maneuver (Both techniques slider and tensioner. Placebo laser therapy: patients receive the same treatment on the same area as experimental group for the same period without turning on the device. all 20 will receive Placebo laser therapy: patients receive the same treatment on the same area as experimental group for the same period without turning on the device.

Procedure: neural mobilizationOther: placebo laser therapy

Interventions

(Eme Physio, Lasermed 2200), GaAs laser, 1 cm2 beam area,7,000 Hz, 17 mW, 1 J/cm2, Pesaro, Italy) . Patient lies in side lying on the non-affected side which is opposite to the side of radicular pain, hip and knee in flexion 90. Twenty points were established for treatment, 12 over the lumbar spine, at the same Side of the radicular pain, from l2 to s1 vertebra, distance between these points is 2 cm. In the thigh, eight points were marked at equal distances from each other, four in the path of l5 root and four in the path of s1 root from hip to knee. The leaser probe is held in 90 degree over the skin with complete skin contact

Experimental group (B)

Mobilization will be through using slump sitting maneuver (Both techniques slider and tensioner. •The slider neurodynamic mobilization technique: The patient moves actively and conversely from a position of neck and trunk flexion, knee flexion, and ankle plantar flexion, to a position of neck and trunk extension, knee extension and ankle dorsiflexion The tension neurodynamic mobilization technique: The patient moves actively and conversely from a position of neck and trunk extension, knee flexion, and ankle plantar flexion, to a position of neck and trunk flexion, knee extension, and ankle dorsiflexion

Experimental group (B)control group (A)

patients receive the same treatment on the same area as experimental group for the same period without turning on the device.

control group (A)

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients referred from orthopedic surgeon with diagnosis of lumbar disc prolapse and radiculopathy (subacute \>3 weeks or chronic \> 3 months and lasting up to 12 months) .
  • Participants had MRI examination, which confirmed the diagnosis of lumber disc prolapse in addition of radiological changes in the intervertebral discs of the spine and affection of peripheral nerve root.
  • Aged between 30 and 50 years .

You may not qualify if:

  • Patients who had undergone any surgical intervention in the spine. 2- Any other dysfunctions of the spine rather than lumber disc prolapse (fractures, tumors, spondylolisthesis, rheumatic diseases, and cauda equina syndrome).
  • The patient is under any medical treatment. 4- Pregnancy, cardiovascular failure, pacemaker, metal implants, skin lesions in the treatment area.
  • Neurological deficits such as myelopathy, lumber canal stenosis and Piriformis syndrome 6- Malignancy, systemic inflammatory disease, or infectious disease. 7- Acute lumber disc prolapse will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Nasr A Abdelkader, PHD

    Assistant professor, Department of physical therapy for musculoskeletal disorders and its surgeries

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
the patient and the research assistant are blind about the treatment group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor , department of physical therapy for musculoskeletal disorders and its surgeries

Study Record Dates

First Submitted

August 16, 2025

First Posted

August 22, 2025

Study Start

February 1, 2025

Primary Completion

May 25, 2025

Study Completion

June 3, 2025

Last Updated

August 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations