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临床试验/NCT04238117
NCT04238117已完成不适用

Laser Acupuncture Therapy in Postpartum Low Back Pain: A Prospective Randomized Controlled Study

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
106
试验地点
2
主要终点
Change in salivary cortisol values

研究概览

简要总结

Over half of women after giving birth have low back pain (LBP), however, LBP is often accepted as a normal part of postpartum. Unsolved low back pain undoubtedly affects women's physical health and may be negatively affect their psychological health. This study was aimed to investigate the efficacy of laser acupuncture therapy (LAT) in postpartum LBP. Postpartum women with LBP admitted at a postpartum care center were recruited and randomly assigned to the intervention group or the control group. The participants in the intervention group underwent 10 sessions/2 weeks of LAT and received standard obstetric care. The participants in the control group only received standard obstetric care. Primary outcome measurements were Visual Analogue Scale (VAS) for pain and salivary cortisol values. Secondary outcome measurements were Chinese versions of the Roland and Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI) version 2.1and the Perceived Stress Scale (PSS).

研究设计

研究类型
Interventional
分配方式
Non 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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age not less than 20 years
  • Women postpartum within one month
  • Low back pain with visual analogue scale (VAS) score ≧1
  • Low back pain was not relieved by rest for 30 minutes.

排除标准

  • with systemic diseases
  • with cancers
  • with psychiatric diseases
  • under treatment for severe pain by a physician.

结局指标

主要结局

Change in salivary cortisol values

时间窗: 2 weeks

record Salivary cortisol values before intervention and 2 weeks after intervention

Change in visual analogue scale (VAS) for pain

时间窗: 2 weeks

record VAS score for pain before intervention and 2 weeks after intervention

次要结局

  • Perceived stress (PSS)(2 weeks)
  • Roland-Morris Disability Questionnaire (RMDQ)(2 weeks)
  • Chinese version of Oswestry Disability Index (ODI)(2 weeks)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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