Combined Effect of Low Level Laser Therapy and Neural Mobilization on Lumber Disc Prolapse

NCT ID: NCT07138300

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-06-03

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?

Detailed Description

Lumbar disc prolapse is a movement of disc material out of the intervertebral disc space. Protruded nucleus comes in contact with the surrounding nerves, causing their compression that in turn results in severe radicular pain.

The purpose of this study is to assess the combined effect of low level laser therapy and neural mobilization on lumber disc prolapse, this assessment will be done through assessment of pain, functional disability, neural mobility and lumber flexion mobility.

Subjects and Methods : 40 Patients with lumber disc prolapse and radiculopathy based on clinical examination by orthopedic surgeon and (MRI) imaging aged between 30 and 50 years . This study will be a double blinded randomized controlled trial .

After including patients in the study, they will be randomly assigned into 2groups :

Control group (A) (n=20): will receive placebo laser therapy plus neural mobilization.

Experimental group (B) (n=20): patients will receive low level laser therapy plus neural mobilization Both control group and experimental group receive infrared as warming up before treatment for12 sessions, each for 15 min, 3 days per week, for a period of 4 weeks .

All patients will perform all assessment procedures accurately (straight leg raising test, slump test and Schober's test ) and will fill (VAS) and (ODI) accurately.

Mobilization will be through using slump sitting maneuver (Both techniques slider and tensioner).Neural mobilization will be applied in form of 3 sets every set 10 repetitions and the end Position was hold for 5 seconds and the rest between sets was 5 minutes. All the patients will receive 12 sessions (3 times/week for 4 weeks).

: patients receive LLLT will lie 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 and 8 points over thigh for 3 sessions per weak for 4 Weeks.

The hypotheses for this study are:

1. There will be significant improvement in pain after combination of LLLT and neural mobilization.

2. There will be significant improvement in functional disability after combination of LLLT and neural mobilization.

3. There will be significant improvement in lumber flexion mobility after combination of LLLT and neural mobilization.

4. There will be significant improvement in neural mobility after combination of LLLT and neural mobilization.

Conditions

Low Level Laser Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group (B)

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

Group Type: EXPERIMENTAL

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)

Intervention Type: DEVICE

(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

neural mobilization

Intervention Type: PROCEDURE

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

control group (A)

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.

Group Type: ACTIVE_COMPARATOR

neural mobilization

Intervention Type: PROCEDURE

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

placebo laser therapy

Intervention Type: OTHER

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

Interventions

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)

(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

Intervention Type: DEVICE

neural mobilization

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

Intervention Type: PROCEDURE

placebo laser therapy

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 1-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) .

2-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.

3-Aged between 30 and 50 years .

Exclusion Criteria

• 1- 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).

3- The patient is under any medical treatment. 4- Pregnancy, cardiovascular failure, pacemaker, metal implants, skin lesions in the treatment area.

5- 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nasr Awad Abdelkader Othman

assistant professor , department of physical therapy for musculoskeletal disorders and its surgeries

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nasr A Abdelkader, PHD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC\012\004894

Identifier Type: -

Identifier Source: org_study_id