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临床试验/NCT02039037
NCT02039037Unknown不适用

Efficacy of Acupuncture and Electroacupuncture in Patients With Chronic Nonspecific Low Back Pain: Randomized Clinical Trial

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
66
试验地点
2
主要终点
Pain

研究概览

简要总结

Chronic nonspecific low back pain is a major health and socioeconomic responsible for a high rate of employee absenteeism and reduced functional performance. The use of acupuncture as an alternative therapy in the treatment of low back pain and electroacupuncture to enhance the treatment has been effective; however, there is little evidence of the effectiveness of one over the other.

详细描述

OBJECTIVE

To compare the effect of acupuncture and electroacupuncture as an alternative therapy in patients with chronic low back pain to be able to identify whether electroacupuncture has more benefits than just acupuncture in the treatment of low back pain to be more widespread with scientific.

METHOD: Sixty subjects will be randomized into two groups: Group Acupuncture treatment of low back pain (AG) and Group Acupuncture with the use of electroacupuncture (EG). The primary clinical outcomes will be pain, assessed with the numerical pain scale and McGill Pain Questionnaire and disability assessed with Roland Morris Disability Questionnaire. Secondary outcomes will be measured with global perception scale of global perceived effect, quality of life using the Short-Form Health Survey questionnaire (SF-36), Beck Depression (Beck Depression Inventory BDI), Flexibility, kinesiophobia and through bank Wells. The groups will be treated with two weekly sessions lasting about an hour, 6 weeks, totaling 12 sessions. The outcomes will be achieved in the final and initial ratings after six months of treatment completion. Data will be collected by a blinded examiner who also has made the allocation of patients to groups.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Chronic low back pain (pain for more than three months)
  • Be between 20-60 years

排除标准

  • Patients with severe spinal
  • Previous surgeries or scheduled
  • Herniated Disc
  • Rheumatic disease or infection
  • pregnancy
  • metal implants

结局指标

主要结局

Pain

时间窗: 6 weeks

Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire

Functional Disability

时间窗: 6 weeks

Roland Morris Disability Questionnaire

次要结局

  • Scale of Kinesiophobia (TSK)(6 weeks)
  • Quality of life(6 weeks)
  • Global Perceived Effect(6 weeks)
  • Beck Depression(6 weeks)
  • Third finger to the ground(6 weeks)

研究者

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

JOSIELLI COMACHIO

Efficacy of Acupuncture and Electroacupuncture in patients with chronic nonspecific low back pain: randomized clinical trial

University of Sao Paulo

研究点 (2)

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