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临床试验/NCT07138300
NCT07138300已完成不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
pain assessment before and after treatment

研究概览

简要总结

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?

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

the patient and the research assistant are blind about the treatment group.

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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 .

排除标准

  • •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.

研究组 & 干预措施

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

干预措施: 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) (Device)

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

干预措施: neural mobilization (Procedure)

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.

干预措施: neural mobilization (Procedure)

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.

干预措施: placebo laser therapy (Other)

结局指标

主要结局

pain assessment before and after treatment

时间窗: 4 weeks

by visual analog scale (VAS)

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

时间窗: 4 weeks

by Oswestry Disability Index (ODI)

evaluate neural mobility before and after treatment

时间窗: 4weeks

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

evaluate lumbar flexion mobility before and after treatment

时间窗: 4weeks

by Schober's test

Neurological assessment screening of neuropathic pain

时间窗: 4 weeks

by slump test

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nasr Awad Abdelkader Othman

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

Cairo University

研究点 (1)

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