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

NCT07645196 | Not Yet Recruiting

• 1 other identifier: 26169_DYS ECHO
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Dysmenorrhea; Endometriosis

Keywords

Dysmenorrhea; endometriosis; Shear wave elastography; Manual therapy; Physiotherapy; Abdominal mobilization; Tissue stiffness; Chronic pelvic pain; Central sensitization; Menstrual pain

Outcome Measures

Primary Outcomes (2)

• 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).

  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

  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.

  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 (3)

• Change in pain intensity during menstruation

  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

  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

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

Study Arms (2)

Manual Abdominal Mobilization

EXPERIMENTAL

Participants receive standardized abdominal manual mobilization techniques applied by a physiotherapist, once per week over three menstrual cycles. Session duration: 20 min

Procedure: Abdominal manual mobilization

Sham Manual Therapy

SHAM COMPARATOR

Participants receive superficial manual contact in the same anatomical regions without therapeutic intent or pressure, once per week over three menstrual cycles. Session duration matches the experimental group.

Procedure: Sham manual contact

Interventions

Abdominal manual mobilization PROCEDURE

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.

Manual Abdominal Mobilization

Sham manual contact PROCEDURE

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.

Sham Manual Therapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (2)

Vrije Universiteit Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

Isek He2B

Brussels, Brussels Capital, 1160, Belgium

Location

MeSH Terms

Conditions

Dysmenorrhea; Endometriosis

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Steven Provyn, PhD

  Vrije Universiteit Brussel

  STUDY CHAIR

• Bart Roelands, PhD

  Vrije Universiteit Brussel

  STUDY CHAIR

Central Study Contacts

Barnavol Aurélie

CONTACT

+32486714996; aurelie.barnavol@vub.be

Steven Provyn, PhD

CONTACT

+32475454214

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Start date: Beginning 6 months after publication of the main results. End date: Ending 5 years after publication of the main results
• Access Criteria: Data will be available to researchers who submit a methodologically sound proposal. Requests should be directed to the principal investigator at the Vrije Universiteit Brussel. Data requestors will need to sign a data access agreement prior to receiving any data. All shared data will be de-identified to ensure participant confidentiality.

Locations

BE (2)