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临床试验/NCT07022106
NCT07022106招募中不适用

Comparison of Myofascial Release and Kinesiotaping Techniques in the Management of Primary Dysmenorrhea

Medipol University2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年6月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
46
试验地点
2
主要终点
Visual Analogue Scale (VAS)

研究概览

简要总结

This study is investigating the effects of myofascial release technique & kinesiotape in managing dysmenorrhea

详细描述

Dysmenorrhea is a common gynecological disorder characterized by painful menstruation manifested by severe cramps in the lower abdomen. Recent epidemiological studies indicate a global prevalence of 50-90% among women (10-20% with severe symptoms); in Türkiye, studies show a prevalence of 75-85%.Dysmenorrhea is divided into two types: primary dysmenorrhea (PD) and secondary dysmenorrhea. PD is painful menstruation without any underlying pathological condition. The main goal of dysmenorrhea treatment is to significantly improve the patient's well-being and quality of life (QoL) by effectively relieving pain and relieving symptoms by targeting physiological mechanisms. There are various physiotherapy methods that can be used to reduce this pain, such as transcutaneous electrical nerve stimulation (TENS), cryotherapy, myofascial release therapy (MRT), and kinesiology taping (KT).

This single-blind randomized controlled trial will investigate the acute therapeutic effects of Myofascial Release Technique (MRT) versus Kinesio Taping (KT) in 46 females aged 18-30 years with PD. Participants will be randomised into Group 1 (MRT; n = 23) or Group 2 (KT; n = 23), receiving a single intervention session during their most painful menstrual day

All participants will be asked to fill out 3 forms, namely a sociodemographic questionnaire covering age, height, BMI, age at menarche and duration of menstruation, a Visual Analog Scale (VAS) to assess pain level and a Patient Reported Outcomes Measurement System (PROMIS-29 Profile v2.0) to measure quality of life (QoL) at 3 time points (pre-intervention, 8 hours after intervention ,and 3-5 weeks post intervention (at the first menstrual cycle after intervention).

Statistical analyses will be conducted by using SPSS 27.0 (IBM Corp.), with a priori power analysis confirming 95% power (α = 0.05; G*Power v3.1.9.7). Data normality will be verified via the Shapiro-Wilk test. Independent Samples t-tests will compare interventional effects between groups, while one-way ANOVA (with LSD post-hoc tests) will analyze multi-point QoL changes. Paired Samples t-tests will evaluate within-group temporal changes (pre vs. post-intervention).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Diagnosis of primary dysmenorrhea,
  • Moderate-to-severe pain during menstrual days 1-3,
  • Regular menstrual cycles for past 6 months

排除标准

  • Secondary gynaecological conditions,
  • Current use of pain medications,
  • History of pregnancy

结局指标

主要结局

Visual Analogue Scale (VAS)

时间窗: Before the interventions, after 8 hours from the interventions, & 3-5 weeks post-intervention (first menstrual cycle after interventions)

It is a pain assessment tool featuring a 10-cm line marked "No pain" (0 cm) and "Worst pain imaginable" (10 cm). Patients indicate their pain level by marking the line, with scores measured in cm (0-10) and categorised as mild (0-3), moderate (4-6), or severe (7-10)

次要结局

  • Patient-Reported Outcomes Measurement Information System (PROMIS-29 Profile v2.0)(Before the interventions, after 8 hours from the interventions, & 3-5 weeks post-intervention (first menstrual cycle after interventions))

研究者

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

Salma Abdelzaher

Physiotherapist

Medipol University

研究点 (2)

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