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临床试验/NCT03118271
NCT03118271终止不适用

Comparison of the Effect of Lumbar Traction, Spinal Manipulation, and Surgery in the Treatment of Lumbar Disc Herniation

Shin Kong Wu Ho-Su Memorial Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
60
试验地点
1
主要终点
VAS pain score

研究概览

简要总结

To compare the effect of lumbar traction, lumbar spinal manipulation and lumbar surgery in the treatment of LDH.

详细描述

Back pain is the second leading cause of work absenteeism (after upper respiratory tract complaints) and results in more lost productivity than any other medical condition. The lifetime prevalence of back pain exceeds 70% in most industrialized countries,and the 1-year prevalence for an episode of acute low back pain (LBP) has been estimated to be 65%. Sciatica is present in about 25% of those with LBP, and one of the major cause of sciatica is herniation of intervertebral disc (HIVD) of the lumbosacral spine or lumbar disc herniation (LDH). In the United Kindom, the estimated prevalence of LDH is from 1% to 3%. Although 95% of LBP patients recovered in 12 weeks, recurrent pain and disability were common and occurred in 12% over the 18-month observation period.

Disc herniation may be purely annular, purely nuclear, or consist of a combination of annular and nuclear tissues. Nuclear disc herniation track posteriorly between the anterior surface of the posterior longitudinal ligament and the posterior surfaces of the annulus and vertebral body and then into the spinal canal. Disc herniation may be described as protrusion or extrusion (or sequestration, if the displaced disc material has lost completely any continuity with the parent disc); contained or uncontained.

The usual presenting complaint is acute or chronic intermittent LBP with or without sciatica, which is radiating pain in a dermatomal distribution and classically described as a burning, stabbing, or electric sensation, sometimes accompanied with paresthesia. Central disc herniations or herniation that have migrated can each result in a mixed clinical picture or, alternately, signs of stenosis may predominate. The mechanism of pain is mutifactorial, involving mechanical stimulation of the nerve endings in the outer annulus, direct compression on the posterior longitudinal ligament, dura, or nerve root, and/or the chemical inflammatory cascade induced by the exposed nucleus pulposus or annulus fibrosis.The classic straight leg raising (SLR) test or Lasegue test is thought to be a useful clinical test to demonstrate an inflammatory compressive process across single or multiple spinal nerve roots.

Magnetic resonance imaging (MRI) has become the examination of choice for diagnosing LDHs.It has the advantage of having no known side effects or morbidity, no radiation exposure, and is noninvasive. The sensitivity and specificity of MRI in detecting annular tears, disc herniation, and nerve root swelling has been confirmed in several studies. MRI findings have been correlated to clinical findings and are strong predictors of surgical outcomes. However, morphological abnormalities demonstrated by MRI do not always reflect LBP or sciatica. MRI should be interpreted with consideration of full clinical signs, symptoms, and other relevant background.

Treatment of LDH consists of operative and non-operative treatments. Non-operative care of LDH includes a wide range of different methods: lumbar supports, bed rest, oral analgesics and muscle relaxants, lumbar traction, therapeutic exercise, spinal manipulation, epidural steroid injections, and behavioral therapy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age>20 and less than 80 y/o with LDH with moderate to severe (VAS pain > 4) LBP and/or sciatica. LDH should be proved by MRI of the lumbosacral spine. The duration of pain is less than 1 month.

排除标准

  • LBP probable due to serious spinal pathology such as spinal tumor, infection, and inflammatory disease such as ankylosing spondylitis.28
  • LDH with progressive weakness in the lower extremities or symptoms and signs suggesting cauda equina lesion.
  • Concomitant serious medical conditions.
  • History of spinal surgery before.
  • Severe osteoporosis or image studies suggesting instability of the lumbosacral spine.

结局指标

主要结局

VAS pain score

时间窗: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments.

an 10-cm horizontal line will be used to assess average pain intensity in the last 1 week

次要结局

  • Global impression of change(Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments.)
  • Modified Oswestry Disability Questionnaire (MODQ)(Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments.)
  • SF-36(Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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