跳至主要内容
临床试验/NCT01761838
NCT01761838已完成不适用

The Underlying Mechanism of Spinal Manipulative Therapy and the Effect of Pain on Physical Outcome Measures

University of Alberta2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
2
主要终点
Change of Modified Oswestry Low Back Pain Disability Index

研究概览

简要总结

The purpose of this study is to compare changes in spinal stiffness and back muscle activity between spinal manipulative therapy (SMT) responders, non-responders and asymptomatic participants. Additionally, the investigators wanted to compare the amount of lumbar degeneration between SMT responders, non-responders and asymptomatic participants. This study also determines if the presence of pain modifies post-SMT spinal stiffness and back muscle activity.

详细描述

SMT is a common manual therapy for treating patients with mechanical low back pain (LBP). SMT is defined as a high velocity, low amplitude thrust technique. Specifically, the clinician stands beside a supine patient. The patient is passively side-bent towards the side to be manipulated. The clinician passively rotates the patient and then delivers a high velocity, low amplitude thrust to the anterior superior iliac spine in a posteroinferior direction. SMT is indicated for patients with LBP judged to have spinal hypomobility or malalignment. Recently, our collaborators have discovered that LBP subjects who benefit from SMT can be identified prior to treatment by a five-item clinical prediction rule. Compared to non-responders, those who respond to SMT have: 1) more than 30% decrease in the modified Oswestry Disability Index score, 2) a significant and immediate decrease in spinal stiffness, and 3) a concurrent change in lumbar multifidus muscle activity. Taken together, the physical changes experienced by SMT responders alone provide an unique opportunity to better understand the mechanisms underlying SMT.

Since spinal stiffness is an important physical indicator of SMT response, it is important to understand the causal relation between pain, paraspinal/trunk muscle activity and spinal stiffness. Although research has shown positive correlation between pain and muscle activity, and between paraspinal muscle activity and spinal stiffness, the causal relation between pain, paraspinal/trunk muscle activity and spinal stiffness remains unknown. Given this background, an induction of temporary benign experimental pain to asymptomatic individuals can help clarify such causal relation and improve our understanding of physical responses in responders following pain resolution by SMT.

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
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Self ambulatory participants with or without acute/chronic LBP. LBP is defined as pain or discomfort between costal margin and above the gluteal folds, with or without leg pain.
  • All the included LBP participants must have modified Oswestry Disability Index score > 12%
  • Have the ability to lie prone for at least 20 minutes.
  • Asymptomatic participants should be free from LBP at the time of visit.

排除标准

  • With medical 'red flag' conditions such as cancer, cauda equine syndrome, spinal infection, fracture or systemic disease
  • History of arm surgery, shoulder or arm pain that may hinder the arm lifting in prone
  • History of orthopedic or neurological surgery to the spine, pelvis or hips
  • Inflammatory or active infective processes involving spine or shoulder
  • Spondylolisthesis, ankylosing spondylitis, scoliosis of greater than 20 degrees (Cobb's angle)
  • Pregnancy
  • Osteoporosis
  • Neurologic deficit or signs of nerve root compression
  • Congenital spinal disorder (such as spina bifida),
  • Participation in competitive sports more than 3 times per week
  • History of spinal manipulation or lumbar multifidus stabilization exercise training within the past 4 weeks
  • Additional exclusion criteria for asymptomatic participants include: back pain in the preceding year, or exceeding 1 week; missed at least 1 work day because of back pain; and consultation for a back problem.

结局指标

主要结局

Change of Modified Oswestry Low Back Pain Disability Index

时间窗: baseline, Day 3, and 1 week

It is a questionnaire to assess the participants' perceived low back pain related functional disability.

Change of 11-point Numeric Pain Rating Scale

时间窗: baseline, Day 3, and 1 week

It is a scale to measure the perceived pain intensity by the participants.

Change in Body Pain diagram

时间窗: Baseline, Day 3, and 1 week

The diagram will be used to demarcate the location and area of symptoms

次要结局

  • Change in measurement of lumbar multifidus muscle thickness by rehabilitative ultrasound imaging(Baseline, Day 3, and 1 week)
  • Change of spinal stiffness testing by a mechanical indentation machine(Baseline, Day 3, and 1 week)
  • Electromyography of trunk muscles(At the third visit (1 week from the baseline))
  • Magnetic resonance imaging of lumbar region for participants with low back pain(At the beginning and immediately after the first visit (an expected average of 1 hour apart))
  • Change in Borg Category-Ratio Scale of Perceived Exertion(Baseline, Day 3, and 1 week)
  • Global Rating Of Change(1 week after baseline)
  • Fear Avoidance Beliefs Questionnaire(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验