Vibration, Massage, and Myofascial Release in Primary Dysmenorrhea

Официальное название

Comparison of Vibration Therapy, Classical Abdominal Massage, and Myofascial Release Applications in Primary Dysmenorrhea

Обзор

This randomized, assessor-blinded, four-arm, parallel-group controlled trial aims to compare the effects of vibration therapy, abdominal massage, and myofascial release with an education-only control intervention in women with primary dysmenorrhea. Seventy-two women aged 18 to 30 years will be randomized in a 1:1:1:1 ratio. All participants will receive standard education about primary dysmenorrhea. The three intervention groups will additionally receive their assigned treatment twice weekly for 12 weeks, covering three menstrual cycles. Menstrual pain, pain characteristics, pressure pain threshold, menstrual symptoms, and symptoms associated with central sensitization will be evaluated at baseline and after the intervention by a blinded assessor.

Подробное описание

Primary dysmenorrhea is a common condition characterized by menstrual pain that may negatively affect daily activities and school or work performance. This study will investigate three non-pharmacological treatment approaches for managing primary dysmenorrhea.

A total of 72 women aged 18 to 30 years with primary dysmenorrhea will be randomly assigned in a 1:1:1:1 ratio to one of four groups: vibration therapy, abdominal massage, myofascial release, or education-only control. All participants will receive standardized education about primary dysmenorrhea and menstrual pain management.

The vibration therapy group will receive treatment using a vibrating massage ball applied to the abdominal and lumbosacral regions. The abdominal massage group will receive standardized massage applied to the lower abdominal and suprapubic regions. The myofascial release group will receive treatment targeting the abdominal, lumbopelvic, and sacral regions. The control group will receive education only. The interventions will be administered twice weekly for 12 weeks, covering three menstrual cycles.

Assessments will be conducted at baseline and after the 12-week intervention. Outcomes will include menstrual pain characteristics, pressure pain threshold measured by algometry at six standardized anatomical points, menstrual symptoms, and symptoms associated with central sensitization. Outcome assessments will be performed by an assessor blinded to group allocation.

Вмешательства

• Устройство Vibration Therapy Group
  Vibration will be applied to the abdominal and lumbar-sacral regions. This treatment will be performed twice a week for 12 weeks.
• Другое Abdominal Massage
  A standardized abdominal massage protocol will be applied manually to the lower abdominal and suprapubic regions. The intervention will be delivered twice weekly for 12 weeks.
• Другое Myofascial Release
  Manual myofascial release techniques will be applied to the abdominal, lumbopelvic, and sacral regions using a standardized treatment protocol. The intervention will be delivered twice weekly for 12 weeks.
• Другое Education
  Standardized education will include information about menstrual pain management, considerations during daily activities, and general non-pharmacological approaches. The same education will be provided to participants in all four study arms.

Первичные конечные точки

• Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score [Срок оценки: Baseline and post-intervention at Week 12]

Вторичные конечные точки (5)

• Change in Short-Form McGill Pain Questionnaire Sensory Subscore [Срок оценки: Baseline and post-intervention at Week 12]
• Change in Short-Form McGill Pain Questionnaire Affective Subscore [Срок оценки: Baseline and post-intervention at Week 12]
• Change in Pressure Pain Threshold Measured by Algometry [Срок оценки: Baseline and post-intervention at Week 12]
• Change in Menstrual Symptom Questionnaire Mean Total Score [Срок оценки: Baseline and post-intervention at Week 12]
• Change in Central Sensitization Inventory Total Score [Срок оценки: Baseline and post-intervention at Week 12]

Критерии участия

• Inclusion Criteria:
• Female participants aged 18 to 30 years.
• Having regular menstrual cycles during the previous 6 months.
• Having a diagnosis consistent with primary dysmenorrhea following evaluation by an obstetrician and gynecologist.
• Experiencing menstrual pain in at least 2 of the previous 3 menstrual cycles.
• Having menstrual pain intensity of 4 or higher on a 0-10 Visual Analog Scale.
• Voluntarily agreeing to participate in the study and providing written informed consent.

Критерии исключения

• Secondary dysmenorrhea.
• Diagnosis of endometriosis, uterine fibroids, ovarian cysts, or pelvic inflammatory disease.
• History of gynecological surgery.
• Pregnancy or suspected pregnancy.
• Having given birth within the previous 6 months.
• Recent initiation of hormonal treatment.
• Chronic pelvic pain or a neurological, rheumatological, or systemic inflammatory disease.
• Having received manual therapy or physiotherapy targeting the abdominal or lumbopelvic region within the previous 3 months.
• Skin lesions, infection, open wounds, or other dermatological conditions in the treatment regions.
• Any clinical condition considered a contraindication to vibration therapy.
• Inability to comply with the study protocol -

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

Простое слепое

Основная цель

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul Medipol University — Istanbul

Идентификаторы

NCT: NCT07731243 · E-10840098-50.04-4782

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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