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临床试验/NCT03333213
NCT03333213已完成不适用

Gua Sha Therapy for Chronic Low Back Pain: a Randomized Controlled Trial

Universität Duisburg-Essen0 个研究点目标入组 50 人开始时间: 2009年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
Pain intensity

研究概览

简要总结

Chronic low back pain is a major public health burden with only limited evidence of effectiveness for complementary and traditional therapies. Gua Sha is a traditional East Asian therapy traditionally used in the treatment of spinal pain. This study aimed to test the efficacy of Gua Sha therapy in patients with chronic low back pain A total of 50 patients with chronic low back pain were randomized to either two Gua Sha treatments (n=25) or a waitlist control group (n=25). Primary outcome measure was current pain intensity on a 100-mm visual analog scale; secondary outcome measures included back-related function (Oswestry Disability Index), movement-related pain (modified Pain on Movement Questionnaire), as well as pressure pain threshold, mechanical detection threshold, and vibration detection threshold.

详细描述

Chronic low back pain is a major public health burden with only limited evidence of effectiveness for complementary and traditional therapies. Gua Sha is a traditional East Asian therapy traditionally used in the treatment of spinal pain. This study aimed to test the efficacy of Gua Sha therapy in patients with chronic low back pain A total of 50 patients with chronic low back pain were randomized to either two Gua Sha treatments (n=25) or a waitlist control group (n=25). Primary outcome measure was current pain intensity on a 100-mm visual analog scale; secondary outcome measures included back-related function (Oswestry Disability Index), movement-related pain (modified Pain on Movement Questionnaire), as well as pressure pain threshold, mechanical detection threshold, and vibration detection threshold.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • non-specific low back pain at least once weekly for at least the previous 3 months
  • average back pain intensity hat least 40mm on a 100mm visual analog scale (VAS)

排除标准

  • specific low back pain due to trauma, disc protrusion, whiplash, congenital deformity of the spine, spinal stenosis, neoplasm, inflammatory rheumatic disease, or oncologic disease
  • pregnancy
  • invasive treatment of the spine or spinal surgery within the previous 4 weeks
  • oral steroids or anticoagulants
  • hemophilia or a skin condition in the area to be treated
  • started a new treatment for low back pain within the previous month or planning to start a new treatment within the next month

研究组 & 干预措施

Gua Sha therapy

Experimental

Patients' backs were first covered with Tumarol N Balsam. The study physician then applied a round-edged instrument (the inside smooth edged lip of a metal cap) to patients' skin in downward strokes. Patients were treated twice with a 7-day interval.

干预措施: Gua Sha (Other)

Waitlist control group

No Intervention

Treatments in the control group were not regulated but patients were asked to continue their self-directed medical care. They were offered the Gua Sha therapy once the trial was concluded.

结局指标

主要结局

Pain intensity

时间窗: 12 weeks

100-mm visual analogue scale (VAS) ranging from 0mm meaning 'no pain at all' to 100mm meaning 'the worst pain imaginable'

次要结局

  • Functional disability(12 weeks)
  • Mechanical detection threshold (MDT)(12 weeks)
  • Pain on movement(12 weeks)
  • Pressure-pain threshold (PPT)(12 weeks)
  • Adverse events(12 weeks)
  • Vibration detection threshold (VDT)(12 weeks)

研究者

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

Holger Cramer

Research Director

Universität Duisburg-Essen

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