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

ConditionsDysmenorrheaEndometriosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorVrije Universiteit Brussel

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

female sex

aged 18 to 50 years

clinical diagnosis of dysmenorrhea (cyclic pelvic pain during menstruation)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Abdominal manual mobilization

    Procedure/Surgery

    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 broad ligament landmarks; other hand holds the patient's legs. Opposing hand movements create an abdominal stretch. Lateral uterine mobilizations performed abdominally on both sides. Hypopressive abdominal exercises (5 min): Therapist guides patient through hypopressive technique: exhale, breath-hold, false thoracic inspiration, abdominal draw-in, transverse abdominis contraction. Hold 10 seconds, then release. Position: standing, knees flexed, hands pressing on thighs.

  • Sham manual contact

    Procedure/Surgery

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Manual Abdominal MobilizationExperimental treatment 1 intervention
Group B: Sham Manual TherapySham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in uterine cervix tissue stiffness measured by shear wave elastography

Transabdominal shear wave elastography of the uterine cervix. Stiffness values expressed in kilopascals (kPa) and/or meters per second (m/s).

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.
2

Change in abdominal tissue stiffness measured by shear wave elastography

Bilateral transabdominal shear wave elastography at 4 cm left and right of the umbilicus, at three depths: rectus abdominis (\~1-3 cm), deep fascia (\~2-4 cm), and uterine depth.

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 outcomes

1

Change in pain intensity during menstruation

Pain will be assessed using a numerical pain scale (ranging from 0 = no pain to 10 = the worst pain imaginable).

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.
2

Change in health-related quality of life

SF-36 Short Form questionnaire (0-100 scale, higher scores = better 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.
3

Intra- and inter-rater reliability of shear wave elastography measurements

Reliability of transabdominal shear wave elastography measurements will be assessed at the uterine cervix and bilateral abdominal regions. Intra-rater reliability will be evaluated by repeating measurements within the same session with repositioning. Inter-rater reliability will be assessed by two independent assessors blinded to each other's results.

Time frame
Baseline (Day 0 - Cycle 1). Each cycle lasts between 28 and 31 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vrije Universiteit Brussel

Lead sponsor

Source ClinicalTrials.gov

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