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临床试验/NCT06762106
NCT06762106已完成不适用

Effect of Shockwave Therapy on Low Back Pain in Primary Dysmenorrhea

Deraya University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月10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
60
试验地点
1
主要终点
Pain assessment

研究概览

简要总结

Primary dysmenorrhea (PD), defined as menstrual pain without any structural lesions, usually begins shortly before or immediately after the onset of the menstrual cycle and commonly lasts for 48 to 72 hour

详细描述

Dysmenorrhea is one of the most common gynecological conditions in women. Primary dysmenorrhea (PD), defined as menstrual pain without any structural lesions, usually begins shortly before or immediately after the onset of the menstrual cycle and commonly lasts for 48 to 72 hour. It is accompanied by general symptoms, such as nausea and vomiting, malaise, weakness, lower backache, and diarrhea. In ovulatory cycles, women secrete high levels of or have increased sensitivity to prostaglandins. These prostaglandins may stimulate myometrial contractions and sensitize pain fibers, and thus induce pelvic pain.

Females of reproductive age often suffer from dysmenorrhea, a painful condition. Despite dysmenorrhea being generally considered a benign condition, a significant disability can result from it. Researchers suggest that dysmenorrhea has been linked to migraines, headaches, and fibromyalgia, among other painful disorders. The authors reported further evidence that dysmenorrhea can alter noxious sensory processing.

Primary dysmenorrhea usually begins six to 12 months after menarche and is characterized by spasmodic cramping pain in the lower abdomen that can radiate to the lower back and anterior or inner thighs. The pain usually has a clear temporal pattern: it begins a few hours before or at the start of menstruation, is most intense at onset, gradually waning over two to three days.

The purpose of this study was to investigate the effectiveness shockwave therapy on low back pain in 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
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Their ages ranged from 18 to 30 years.
  • •Their BMI were not exceeding 29 Kg/m
  • •All patients were clinically diagnosed as low back pain during Primary Dysmenorrhea according to the Primary Dysmenorrhea Consensus Guideline

排除标准

  • •Any known chronic disease (such as cardiovascular or renal diseases) or secondary dysmenorrhea.
  • •Being pregnant or planning to get pregnant any time during the trial.
  • •Having received other treatments for PD in the past half year.
  • •Irregular menstrual cycles.
  • •Mental or neurological disorder

研究组 & 干预措施

Hot back group

Active Comparator

30 subjects were treated by hot back in the first 3 days of the menstrual cycle (follicular phase) for three consecutive menstrual cycles

干预措施: hot back (Radiation)

shock wave and hot back group

Experimental

30 subjects were treated by hot back and shockwave therapy in the first 3 days of the menstrual cycle (follicular phase) for three consecutive menstrual cycles

干预措施: shockwave therapy (Radiation)

结局指标

主要结局

Pain assessment

时间窗: every month for three menstrual cycle

VAS scoring method. 0 is the least while 10 is the highest

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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