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临床试验/NCT03593057
NCT03593057已完成不适用

Effectiveness of a Manual Therapy Protocol in Women With Dysmenorrhea

University of Valencia4 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2018年6月5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
39
试验地点
4
主要终点
Visual Analog Scale of Pain.

研究概览

简要总结

The objective of this clinical study would be to verify if manual therapy is effective in the treatment to reduce pain in women suffering from primary dysmenorrhea.

Material and methods In this experimental study, women diagnosed with primary dysmenorrhea will be included, which will be divided randomly into two groups: an intervention group and a comparator group.

The study will last nine weeks (3 menstrual cycles). Patients in the intervention group will receive 3 treatment sessions.

The evaluation will include pain, the quality of life, the global impression of change, personal body satisfaction and global self-perception and the pain perception.

详细描述

Introduction The prevalence of primary dysmenorrhoea is high and has an impact on quality of life, pain and disability. The cause is due to the increase of postaglandins that can be influenced by the lowering of progesterone. In short, there is a complex relationship between hormones and the immune system.

Manual therapy increases the mobility of the sacrum and tissues of the pelvis, increasing the blood supply and the uterus that has parasympathetic innervation through the sacrum improves mobility, motility and irrigation.

The ligaments, fasciae and tissue of the pelvis improve their irrigation through fascial, mobility and visceral techniques, which would improve uterine mobility by anatomical connections with these structures. With better mobility the uterus, and therefore the smooth muscle, would have more irrigation and less pain and hypercontractivility.

The adjacent tissues, perineum, triangular ligament, innervated by the vagus nerve, improve

The main objective is the improvement of quality of life, personal body satisfaction and overall self-perception and pain reduction in women with dysmenorrhea after treatment with manual therapy and provide information and advice on self-care and menstrual awareness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with menstrual pain of more than 6 months of evolution.
  • Women with pain equal to or greater than 4 on the visual analogue scale in more than half of their one-year menstrual cycles.

排除标准

  • Hormone treatment
  • Contraindication to any of the treatments
  • Participate in this period of no functional recovery program or physiotherapy treatment.

研究组 & 干预措施

Manual therapy protocol

Experimental

Manual therapy protocol and self-care advice and body awareness. Three sessions of manual therapy will be applied, (at the beginning, at 2 weeks and at 3 weeks).

干预措施: Control group (Other)

Control group.

Active Comparator

Advice on self-care and body awareness.

干预措施: Manual therapy (Other)

结局指标

主要结局

Visual Analog Scale of Pain.

时间窗: 9 weeks

The participants are asked to mark the intensity of pain from 1 to 10, with 1 being almost non-existent and 10 being the worst pain imaginable.

次要结局

  • SF-36 quality of life scale.(9 weeks)
  • Global Impression Change Scale.(9 weeks)
  • Body Satisfaction and global self-perception Questionnaire.(9 weeks)
  • McGill pain perception questionnaire.(9 weeks)

研究者

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

GEMMA V ESPÍ LÓPEZ, PhD

Principal Investigator

University of Valencia

研究点 (4)

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