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Идёт набор NCT06492148

Myofascial Release Technique in Women With Primary Dysmenorrhea

Без фазы С лечением Dysmenorrhea Primary Central Sensitisation Myofascial Trigger Point Pain Menstrual Discomfort

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, Sham-Myofascial Release.
Кому может быть актуально
Состояния в реестре: Dysmenorrhea Primary, Central Sensitisation, Myofascial Trigger Point Pain, Menstrual Discomfort. Базовые параметры: 18 лет — 35 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effect of Myofascial Release Technique on Central Sensitization, Myofascial Trigger Point and Menstrual Symptoms in Women With Primary Dysmenorrhea: Sham-Controlled, Randomized Double-Blind Study

Обзор

It has been found that women with dysmenorrhea have active trigger points, particularly in the rectus abdominis, oblique abdominal muscles, quadratus lumborum, and paraspinal muscles. The myofascial release technique is a widely used manual therapy method characterized by the application of low-load, long-duration mechanical forces to manipulate the myofascial complex. This technique aims to restore optimal length, alleviate pain, and improve function. This study aims to examine the effect of the myofascial release technique on central sensitization, myofascial trigger points, and menstrual symptoms in women with primary dysmenorrhea.

Подробное описание

During the evaluation period, the participants' musculoskeletal pain threshold and tolerance will be measured using an algometer, about trigger points on the identified muscles (rectus abdominis, quadratus lumborum, erector spinae, and tibialis anterior). A total of 40 women, aged 18-40, diagnosed with primary dysmenorrhea by a gynecologist, will be included in the study. The initial assessment of the participants will be conducted on their most painful days. Participants will be randomized into two groups: the myofascial release technique group (study group) and the placebo myofascial release technique group (control group). The interventions will be conducted over 10 sessions during one menstrual cycle, and all evaluations will be repeated after the treatment period. The study will be conducted as a double-blind trial, ensuring that both the evaluators and the patients are blind to the group assignments.

Вмешательства

  • Другое Myofascial Release
    The myofascial release technique is a widely used manual therapy method characterized by low-load, prolonged mechanical forces applied to manipulate the myofascial complex, aiming to restore optimal length, alleviate pain, and improve function.
  • Другое Sham-Myofascial Release
    The hands of the researcher applying the technique will be placed in the same areas as the myofascial release technique, with only the palms in light contact for the same duration. However, no intervention will be made to create any pressure or open the tissue barrier.

Первичные конечные точки

  • Pain Pressure Threshold [Срок оценки: Baseline (First menstruation cycle)]
  • Pain Pressure Threshold [Срок оценки: through study completion, an average of 3 months]
  • Central Sensitization [Срок оценки: Baseline (First menstruation cycle)]
  • Central Sensitization [Срок оценки: through study completion, an average of 3 months]
  • Menstrual pain intensity [Срок оценки: Baseline (First menstruation cycle)]
  • Menstrual pain intensity [Срок оценки: through study completion, an average of 3 months]
Вторичные конечные точки (8)
  • Menstrual Attitude [Срок оценки: Baseline (First menstruation cycle)]
  • Menstrual Attitude [Срок оценки: through study completion, an average of 3 months]
  • Health-related quality of life [Срок оценки: Baseline (First menstruation cycle)]
  • Health-related quality of life [Срок оценки: through study completion, an average of 3 months]
  • Anxiety [Срок оценки: Baseline (First menstruation cycle)]
  • Anxiety [Срок оценки: through study completion, an average of 3 months]
  • The Body Awareness [Срок оценки: Baseline (First menstruation cycle)]
  • The Body Awareness [Срок оценки: through study completion, an average of 3 months]

Критерии участия

Критерии включения

  • Diagnosed with Primary Dysmenorrhea according to the Primary Dysmenorrhea Consensus Guide,
  • Having regular menstruation in the last 6 months (28±7 days)
  • Those who had menstrual pain between 40 mm and 100 mm according to the Visual Analogue Scale (VAS) in the last 6 months

Критерии исключения

  • Diagnosed with Secondary Dysmenorrhea,
  • Having given birth,
  • Those with serious gastrointestinal, urogynecological, or autoimmune diseases or other chronic pain syndromes,
  • Undergoing urogynecological surgery,
  • Those who are pregnant or suspected of pregnancy,
  • Those who use analgesics or non-pharmacological agents other than NSAIDs for menstrual pain,
  • Those using intrauterine or oral contraceptives,
  • Those taking extra supplements such as magnesium, which may affect treatment

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
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi Universit — Ankara

Идентификаторы

NCT: NCT06492148 · 2023 - 1577

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗