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临床试验/NCT04866355
NCT04866355已完成不适用

Short-term Effects of Lumbar Spine Manipulation Versus Pharmacological Therapy in Young Women With Primary Dysmenorrhea: a Randomized Controlled Trial.

University of Alcala2 个研究点 分布在 2 个国家目标入组 42 人开始时间: 2021年2月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
2
主要终点
Pain intensity

研究概览

简要总结

Many treatments like acupuncture, manipulative therapy and pharmacological therapy have been proposed to alleviate symptoms associated with dysmenorrhea. However, no study has previously compared lumbar spine manipulation to pharmacological therapy in the treatment of primary dysmenorrhea.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Presented with persistent primary dysmenorrhea lasting for three or more consecutive menstrual periods
  • Presented menstrual cycles no longer than 35 days

排除标准

  • Presented any other gynecological pathologies
  • Systemic diseases
  • Previous surgical interventions for gynecological complaints
  • Depression
  • Were receiving any other treatment for primary dysmenorrhea.

研究组 & 干预措施

Lumbar spine manipulation

Experimental

Application of lumbar spine manipulation by a physical therapist.

干预措施: Lumbar spine manipulation (Other)

Lumbar spine manipulation plus pharmacological therapy

Active Comparator

Application of lumbar spine manipulation by a physical therapist along with pharmacological therapy.

干预措施: Lumbar spine manipulation (Other)

Lumbar spine manipulation plus pharmacological therapy

Active Comparator

Application of lumbar spine manipulation by a physical therapist along with pharmacological therapy.

干预措施: Hyoscine and Ibuprofen (Drug)

Pharmacological therapy

Active Comparator

Application of pharmacological therapy

干预措施: Hyoscine and Ibuprofen (Drug)

结局指标

主要结局

Pain intensity

时间窗: Change from baseline at 3 days

Pain intensity measured with a visual analogue scale

次要结局

  • Pressure pain threshold measured in tibialis malleolus(Change from baseline at 3 days)
  • Low-back related disability(Change from baseline at 1 month)
  • Pressure pain threshold measured in peroneal malleolus(Change from baseline at 3 days)
  • Anxiety and depression(Change from baseline at 1 month)

研究者

发起方
University of Alcala
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Daniel Pecos Martín

Doctor

University of Alcala

研究点 (2)

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