Effects of Physiotherapy on Ultrasound and Clinical Parameters in Women With Dysmenorrhea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Abdominal manual mobilization, Sham manual contact.
- Who it may be relevant to
- Registry conditions: Dysmenorrhea, Endometriosis. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Physiotherapy on Ultrasound and Clinical Parameters in Women With Dysmenorrhea With or Without Endometriosis
Overview
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).
Interventions
- Procedure 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 - Procedure 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.
Primary outcome measures
- Change in uterine cervix tissue stiffness measured by shear wave elastography [Time frame: 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 [Time frame: 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.]
Secondary outcome measures (3)
- Change in pain intensity during menstruation [Time frame: 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 [Time frame: 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 [Time frame: Baseline (Day 0 - Cycle 1). Each cycle lasts between 28 and 31 days.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Belgium · 2 centers
- Vrije Universiteit Brussel — Brussels
- Isek He2B — Brussels
Identifiers
NCT: NCT07645196 · 26169_DYS ECHO