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临床试验/NCT00376350
NCT00376350已完成2 期

Dose-Response/Efficacy of Manipulation for Chronic LBP

University of Western States2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
400
试验地点
2
主要终点
Modified Von Korff Pain Scale for low back pain

研究概览

简要总结

This study will determine the number of visits to a chiropractor for spinal manipulation, light massage, and ultrasound necessary for optimal relief of chronic low back pain. The study will also determine the effectiveness of spinal manipulation.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current episode of low back pain
  • mechanical origin
  • Threshold low back pain level

排除标准

  • Contraindications to spinal manipulation or massage
  • Complicating conditions that could confound clinical outcome
  • Prophylactic use of prescription medication
  • Health-related litigation, claims, or disability compensation

结局指标

主要结局

Modified Von Korff Pain Scale for low back pain

时间窗: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks

Modified Von Korff Disability Scale

时间窗: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks

次要结局

  • Pain days(baseline 1&2, 6, 12, 18, 24, 39, 52 weeks)
  • Disability days(baseline 1&2, 6, 12, 18, 24, 39, 52 weeks)
  • Low back pain unpleasantness(baseline 2, 6, 12, 18, 24, 39, 52 weeks)
  • Fear avoidance beliefs(baseline 2, 6, 12, 18, 24, 39, 52 weeks)
  • General health status/QoL(baseline 2; 12, 24, 39, 52 weeks)
  • Patient satisfaction(12 wk)
  • Healthcare utilization(baseline 2; 6, 12, 18, 24, 39, 52 weeks)
  • Objective measures(Baseline 2, 6 wk)
  • Bias monitoring(baseline 1&2; 6, 12, 18, 24, 39, 52 weeks)

研究者

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

Mitchell Haas

Associate Vice President of Research

University of Western States

研究点 (2)

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