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Идёт набор NCT07022106

Comparison of Different Physiotherapy Techniques in Dysmenorrhea

Без фазы С лечением Dysmenorrhea Primary

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Myofascial Release Therapy (MRT) Group, Kinesiotape (KT) Group.
Кому может быть актуально
Состояния в реестре: Dysmenorrhea Primary. Базовые параметры: 18 лет — 30 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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

Подробное описание

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).

Вмешательства

  • Другое Myofascial Release Therapy (MRT) Group
    Myofascial Release Therapy (MRT) involves hands-on palpation to detect fascial restrictions, followed by 60-90 seconds of sustained pressure to release tension. In the supine position, the target areas include the superficial fascia, transversalis fascia, and extraperitoneal fascia, while in the prone position, the focus shifts to the thoracolumbar fascia and the erector spinae complex. This technique aims to restore mobility and reduce restrictions within the fascial system. Frequency: Each pa
  • Другое Kinesiotape (KT) Group
    Kinesio Taping (KT) Intervention Description: Participants will receive a standardized 3-tape sensory modulation technique using Kinesiotape, applied to the abdomen and sacrum to target fascial tension and visceral pain in primary dysmenorrhea. Procedure: Abdominal Application (Two Tapes, 0% Stretch): Horizontal Tape: Placed between the iliac crests (lower abdomen) to reduce fascial tension. Vertical Tape: Applied from the navel to the pubic symphysis to modulate visceral pain signaling.

Первичные конечные точки

  • Visual Analogue Scale (VAS) [Срок оценки: Before the interventions, after 8 hours from the interventions, & 3-5 weeks post-intervention (first menstrual cycle after interventions)]
Вторичные конечные точки (1)
  • Patient-Reported Outcomes Measurement Information System (PROMIS-29 Profile v2.0) [Срок оценки: Before the interventions, after 8 hours from the interventions, & 3-5 weeks post-intervention (first menstrual cycle after interventions)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • İstanbul Medipol University — Istanbul

Идентификаторы

NCT: NCT07022106 · E-10840098-202.3.02-582

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗