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ClinicalTrials.gov ID

NCT07645196

Lead Sponsor

Vrije Universiteit BrusselOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

80Estimated

Last Update Posted

Jun 12, 2026Actual

Start Date

Sep 2026Estimated

Primary Completion Date

Sep 2028Estimated

Completion Date

Sep 2028Estimated

Official Title

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

Brief Summary

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.

Detailed Description

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).

• Dysmenorrhea
• Endometriosis

• Abdominal manual mobilization
• Sham manual contact

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Vrije Universiteit BrusselOTHER

aurelie.barnavol@vub.be+32486714996