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临床试验/NCT04427423
NCT04427423已完成不适用

Experimental-controlled, Randomized, Single Blind Trial of Effectiveness of Positional Distraction With Stabilization Exercises Versus Stabilization Exercises Alone in the Management of Lumbar Radiculopathy.

Dow University of Health Sciences1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2020年4月10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
96
试验地点
1
主要终点
Change from baseline Pain intensity at 8 weeks

研究概览

简要总结

This study evaluate the addition of positional distraction to stabilization exercises in the treatment of lumbar radiculopathy in adults. Half of the patients will recieve positional distraction and stabilization exercises in combination, while the other half will recieve stabilization exercises only.

详细描述

In positioanl distraction making use of the body position to produce traction at an isolated spinal level to maximally open the affected neuroforamen. It is an alternative to lumbar mechanical traction.

The spinal level of vertebral level requiring traction is palpated and a soft roll is placed and the patient side lies on the unaffected side. For further distraction both hips are flexed until movement is noted at the spinal level needing traction.

Further, distraction applied by rotating upper trunk to opposite side of pain.

Stabilization exercises are mainly used for the stability of joints and for improving muscle strength.

The first step of lumbar stabilization exercises are to maintain functional back positions during all activities. The second step is to improve strength and endurance of the core muscles.

研究设计

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

盲法说明

The patients were blinded from the treatment groups that either he/she are in experimental or control 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

  • •Clinical diagnosis of lumbar radiculopathy
  • •Age limit 30-50 years
  • •Both males and females
  • •Pain history more than 12 weeks but less than one year
  • •Patient having lumbar disc bulge at maximum two adjacent levels

排除标准

  • •Any type of tumor and infection in the spine
  • •Spondylolisthesis at L4- L5, L5-S1
  • •Fracture of the lumbar spine
  • •Sciatica other than lumbar region (piriformis syndrome)
  • •Acute cardiopulmonary conditions
  • •Morbid obesity (BMI > 30)

研究组 & 干预措施

Positional Distraction plus Stabilization Exercise group

Experimental

The treatment group will receive positional distraction with stabilization exercises

干预措施: physical therapy treatment (Other)

Stabilization Exercise group

Active Comparator

control group will be treated with stabilization exercises only.

干预措施: physical therapy treatment (Other)

结局指标

主要结局

Change from baseline Pain intensity at 8 weeks

时间窗: All the subjects were assessed before and after 8 weeks of treatment.

The pain intensity measured on self reported Visual Analogue Scale. (0 means no pain and 10 is the high intensity of pain).

Change from baseline Disability at 8 weeks

时间窗: All the subjects were assessed before and after 8 weeks of treatment.

The disability were assessed on Roland Morris Disability Questionnaire. where 0 means no disability and 24 is the high disability.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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