Effects of Physiotherapy on Ultrasound and Clinical Parameters in Women With Dysmenorrhea

Официальное название

Effects of Physiotherapy on Ultrasound and Clinical Parameters in Women With Dysmenorrhea With or Without Endometriosis

Обзор

Dysmenorrhea affects up to 90% of women of reproductive age and represents a significant public health concern. Beyond prostaglandin-mediated uterine contractions, dysmenorrhea involves central sensitization mechanisms and myofascial components, including abdominal trigger points. Despite growing interest in physiotherapy for chronic pelvic pain, objective data on tissue-level changes induced by manual therapy remain scarce. This randomized single-blind sham-controlled trial aims to evaluate the effects of abdominal manual mobilization techniques on (1) tissue stiffness measured by shear wave elastography at the uterine cervix and bilateral abdominal regions, and (2) clinical outcomes including pain intensity and quality of life in women with dysmenorrhea, with or without endometriosis. Participants will be randomly assigned to either a treatment group receiving standardized abdominal manual therapy or a sham group receiving superficial manual contact. Assessments will be conducted over three menstrual cycles using shear wave elastography, the Numeric Rating Scale (NRS), and the SF-36 questionnaire.

Подробное описание

Women aged 18 to 50 years with dysmenorrhea will be recruited across two sites in Brussels, Belgium. At baseline (T0), participants will complete questionnaires (SF-36, NRS) and undergo transabdominal shear wave elastography at the uterine cervix and at bilateral peri-umbilical points at three measurement depths.

The intervention consists of one session per week over three menstrual cycles. The treatment group receives standardized abdominal manual mobilization techniques. The sham group receives superficial manual contact without therapeutic intent.

Outcomes are assessed at T0 (baseline), T2 (immediately after first intervention), T3 (end of cycle 2), and T4 (end of cycle 3).

Вмешательства

• Процедура Abdominal manual mobilization
  Abdominal mobilization (10 min): Patient supine, knees flexed. Therapist's ulnar hand borders placed on lower abdomen. During expiration, a cranial manual push is applied following the respiratory cycle; the maneuver is repeated during inspiration. Hands are then placed over the lower ribs at the diaphragmatic domes; a caudal push is applied during inspiration and repeated during expiration. Broad ligament mobilization (5 min): Patient supine, knees flexed. Therapist's cephalad hand placed over
• Процедура Sham manual contact
  Superficial skin contact applied to the abdominal region without therapeutic pressure or mobilization, intended to mimic the experimental intervention in terms of time and positioning.

Первичные конечные точки

• Change in uterine cervix tissue stiffness measured by shear wave elastography [Срок оценки: Baseline (Day 0), immediately after first session (Cycle 1), end of cycle 2 (Cycle 2), end of cycle 3 (Cycle 3). Each cycle lasts between 28 and 31 days.]
• Change in abdominal tissue stiffness measured by shear wave elastography [Срок оценки: Baseline (Day 0), immediately after first session (Cycle 1), end of cycle 2 (Cycle 2), end of cycle 3 (Cycle 3). Each cycle lasts between 28 and 31 days.]

Вторичные конечные точки (3)

• Change in pain intensity during menstruation [Срок оценки: Baseline (Day 0, Cycle 1), end of cycle 2 (Cycle 2), end of cycle 3 (Cycle 3). Each cycle lasts between 28 and 31 days.]
• Change in health-related quality of life [Срок оценки: Baseline (Day 0, Cycle 1), end of cycle 2 (Cycle 2), end of cycle 3 (Cycle 3). Each cycle lasts between 28 and 31 days.]
• Intra- and inter-rater reliability of shear wave elastography measurements [Срок оценки: Baseline (Day 0 - Cycle 1). Each cycle lasts between 28 and 31 days.]

Критерии участия

Критерии включения

• female sex
• aged 18 to 50 years
• clinical diagnosis of dysmenorrhea (cyclic pelvic pain during menstruation)

Критерии исключения

• Pregnancy or breastfeeding
• Delivery less than 1 year prior to enrollment
• History of abdominal or pelvic surgery within the past 3 months
• Diagnosis of fibromyalgia, diabetes, or cancer
• Ongoing manual therapy treatment of the abdominal or genital area

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 2 центра

• Vrije Universiteit Brussel — Brussels
• Isek He2B — Brussels

Идентификаторы

NCT: NCT07645196 · 26169_DYS ECHO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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