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临床试验/NCT00497861
NCT00497861已完成不适用

Comparison of Mechanical Force, Manually Assisted Activator Manipulation Versus Manual Side Posture Manipulation in Patients With Low Back Pain: a Randomized Pilot Study

Cleveland Chiropractic College1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2004年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Revised Oswestry

研究概览

简要总结

This study compared the treatment effect of Activator Methods Chiropractic Technique (AMCT) and manual Diversified type spinal manipulative therapy in a sample of patients with acute and sub-acute low back pain.

详细描述

The purpose of this study is to compare the effects of (MFMA) Activator instrument adjusting to manual side posture (HVL) adjustments in patients with acute low back pain.

Primary outcomes measured include pain measurement with a VAS scale, the use of the Oswestry pain scale questionnaire, and the Bournemouth back pain scale questionnaire.

An additional aim of this study is to evaluate feasibility of recruitment, data collection, and other procedures which can lead to additional studies with larger number of subjects including a control group.

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
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Being 18 years or older;
  • •Having current acute or sub-acute low back pain defined as pain that has not lasted more than 16 weeks;
  • •Minimum score of 30mm on a 100mm visual analog pain scale.

排除标准

  • •Exclusion criteria consisted of the following:
  • •Have any of six possible un underlying causes of low back symptoms in their history (spinal osteomyletisosteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, cauda equina syndrome, or cancer, excluding nonmalignant skin cancer);
  • •Have undergone surgery involving the low back; (
  • •Have received workers'compensation benefits within the preceding year or were potentially involved in litigation relating to back problems;
  • •Pregnancy, because of possible need for exposure to diagnostic x-rays;
  • •Have participated as a subject in research previously at the trial clinic site;
  • •Have received spinal manipulation within the preceding 3 months or on more than three occasions during the preceding year.
  • •Subjects with sciatica were excluded if they had any one of the following:
  • •Ankle dorsiflexion / plantar flexion weakness;
  • •Great toe extensor weakness;
  • •Absence of knee or ankle reflexes;
  • •Loss of light touch sensation in the medial, dorsal, and lateral aspects of the foot;
  • •Ipsilateral straight-leg-raising test (positive result: leg pain at <60°);
  • •Crossed straight-leg-raising test (positive result: reproduction of contralateral pain).
  • •These six neurologic tests allow detection of most clinically significant nerve root compromises resulting from L4-L5 or L5-S1 disc herniations, which together make up more than 90% of all clinically significant radiculopathies attributable to lumbar disc herniations (21-25). Because approximately 12% of ambulatory patients with back pain h
  • •Have symptoms of sciatica or leg pain without neurologic compromise related to lumbar disc herniation,[5] investigators attempted to include such subjects in the trial.
  • •The criteria described above were intended to minimize the likelihood of including subjects with a lumbar disc herniation.

结局指标

主要结局

Revised Oswestry

时间窗: December 2008

次要结局

未报告次要终点

研究者

发起方
Cleveland Chiropractic College
申办方类型
Other

研究点 (1)

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