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临床试验/NCT01303588
NCT01303588已完成2 期

Yoga and Qigong for Elderly Patients With Chronic Low Back Pain

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2011年5月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
176
试验地点
2
主要终点
Functional rating Index (FRI)

研究概览

简要总结

The objective of this study is to evaluate whether yoga or qigong therapy is effective in treating low back pain in elderly patients compared to no therapy (waiting list control). The secondary aim is to compare yoga and qigong.

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

入选标准

  • Men and women ≥ 65 years of age
  • Chronic low back pain since 6 months at least
  • Functional Rating Index (FRI) ≥ 2 last 7 days
  • Informed consent form signed

排除标准

  • Disc prolapse with acute neurological symptoms
  • Previous spinal operations
  • Severe organic or psychiatric disease conditions, not allowing to participate in the trial
  • Use of opioids
  • Drug- and alcohol-addiction
  • Participation in another clinical trial within the last 6 months
  • Participation in yoga or qigong training within the last 12 months
  • Planned physical therapy within study duration

研究组 & 干预措施

Qigong

Active Comparator

干预措施: Qigong (Behavioral)

Waiting Group

No Intervention

Yoga

Active Comparator

干预措施: Yoga (Behavioral)

结局指标

主要结局

Functional rating Index (FRI)

时间窗: 3 months

次要结局

  • SF 36(3, 6 months)
  • Functional Rating Index(6 months)
  • FFb-HR(3, 6 months)
  • Falls(6 months)
  • Tinetti Test(3, 6 months)
  • Adverse events(6 months)
  • Visual Analogue Scale(3, 6 months)
  • Pain medication(6 months)
  • Geriatric Depression Scale(3, 6 months)

研究者

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

Claudia M. Witt

Prof. Dr. med

Charite University, Berlin, Germany

研究点 (2)

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