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临床试验/NCT00065585
NCT00065585已完成3 期

Efficacy of Acupuncture for Chronic Low Back Pain

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 640 人开始时间: 2004年4月最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
640
试验地点
2

研究概览

简要总结

This is a trial to clarify the extent to which acupuncture needling can diminish the effect of chronic back pain on patient functioning and symptoms.

详细描述

This is a 4-arm multi-site randomized controlled trial to clarify the extent to which various types of acupuncture needling can diminish the effect of chronic low back pain on patient functioning and symptoms. Reviews have noted the poor quality of research in this area and urged that scientifically rigorous studies be conducted. Recent higher quality trials suggest acupuncture is a promising treatment for back pain. This study directly addresses methodological shortcomings that have plagued previous studies. A total of 640 subjects (160 per arm) with low back pain lasting at least 3 months will be recruited from group model HMOs in Seattle, WA and Oakland, CA. They will be randomized to one of three different methods of stimulation of acupuncture or to continue usual medical care. Ten treatments will be provided over 7 weeks. The primary outcomes, dysfunction and bothersomeness of low back pain, will be measured at baseline, and after 8, 26, and 52 weeks by telephone interviewers masked to treatment. Analysis of covariance within an intention-to-treat context will be used to analyze the data. Because chronic back pain is a major public health problem and the top reason patients seek acupuncture treatment, a clear, unambiguous assessment is critical for making informed decisions about whether acupuncture should be included as part of conventional care for back pain or covered by insurance. Results of this study will provide the clearest evidence to date about the value of acupuncture needling as a treatment for chronic low back pain.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Accupunture - Experimental Points

Experimental

干预措施: Accupuncture (Procedure)

Acupuncture - Standardized Points

Sham Comparator

干预措施: Accupuncture (Procedure)

Usual care

No Intervention

non needle control

Placebo Comparator

干预措施: Accupuncture (Procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Efficacy of Acupuncture for Chronic Low Back Pain | 临床试验