DysmenorrheaNCT07645196
Effects of Physiotherapy on Ultrasound and Clinical Parameters in Women With Dysmenorrhea
A study testing Abdominal manual mobilization in people with Dysmenorrhea and Endometriosis, run by Vrije Universiteit Brussel at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea, Endometriosis
- What is being tested?
- Abdominal manual mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesBelgium
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female sex
- aged 18 to 50 years
- clinical diagnosis of dysmenorrhea (cyclic pelvic pain during menstruation)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Steven Provyn, PhD contact
Belgium2 sites
Vrije Universiteit Brussel
Brussels, Brussels Capital, 1090
Steven Prof. Provyn, PhD, +475454214, steven.Provyn@vub.be
Aurélie Barnavol, +32486714996, aurelie.barnavol@vub.be
Isek He2B
Brussels, Brussels Capital, 1160
Aurélie Barnavol, +32486714996, aurelie.barnavol@vub.be
Steven Prof. Provyn, PhD, +32475454214, steven.provyn@vub.be
About this study
Official title: Effects of Physiotherapy on Ultrasound and Clinical Parameters in Women With Dysmenorrhea With or Without Endometriosis
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.
Read the 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).
- Conditions
- Dysmenorrhea, Endometriosis
- Being tested
- Abdominal manual mobilization, Sham manual contact
- Keywords
- Dysmenorrhea, endometriosis, Shear wave elastography, Manual therapy, Physiotherapy, Abdominal mobilization, Tissue stiffness, Chronic pelvic pain, Central sensitization, Menstrual pain
- Medical subject headings
- Dysmenorrhea, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal manual mobilizationProcedure or 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 contactProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: Sham manual contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Pain will be assessed using a numerical pain scale (ranging from 0 = no pain to 10 = the worst pain imaginable).
Measured: 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
SF-36 Short Form questionnaire (0-100 scale, higher scores = better quality of life)
Measured: 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
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.
Measured: Baseline (Day 0 - Cycle 1). Each cycle lasts between 28 and 31 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Provyn, PhD, Study chair, Vrije Universiteit BrusselBart Roelands, PhD, Study chair, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645196
- Sponsor's protocol ID
- 26169_DYS ECHO
- Status last verified
- May 2026
- First submitted
- 1 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data underlying the results reported in the published article will be available after de-identification (text, tables, figures and appendices). Data will be available to researchers who provide a methodologically sound proposal, beginning 6 months after publication and ending 5 years after publication. Requests should be directed to the principal investigator. Data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physiotherapy on Ultrasound and Clinical Parameters in Women With Dysmenorrhea With or Without Endometriosis
- ClinicalTrials.gov ID
- NCT07645196
- Acronym / sponsor ID
- 26169_DYS ECHO
- Conditions
- Dysmenorrhea, Endometriosis
- Keywords
- Dysmenorrhea, endometriosis, Shear wave elastography, Manual therapy, Physiotherapy, Abdominal mobilization, Tissue stiffness, Chronic pelvic pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Abdominal Mobilization | Experimental | Procedure: Abdominal manual mobilizationParticipants receive standardized abdominal manual mobilization techniques applied by a physiotherapist, once per week over three menstrual cycles. Session duration: 20 min |
| Sham Manual Therapy | Sham comparator | Procedure: Sham manual contactParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- female sex
- aged 18 to 50 years
- clinical diagnosis of dysmenorrhea (cyclic pelvic pain during menstruation)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal manual mobilizationAbdominal 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. | Procedure or surgery | Manual Abdominal Mobilization |
| Sham manual contactSuperficial skin contact applied to the abdominal region without therapeutic pressure or mobilization, intended to mimic the experimental intervention in terms of time and positioning. | Procedure or surgery | Sham Manual Therapy |
Primary outcome
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.
Transabdominal shear wave elastography of the uterine cervix. Stiffness values expressed in kilopascals (kPa) and/or meters per second (m/s).
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.
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data underlying the results reported in the published article will be available after de-identification (text, tables, figures and appendices). Data will be available to researchers who provide a methodologically sound proposal, beginning 6 months after publication and ending 5 years after publication. Requests should be directed to the principal investigator. Data requestors will need to sign a data access agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Provyn, PhD contact
Steven Provyn, PhD study chair
Vrije Universiteit Brussel
Bart Roelands, PhD study chair
Vrije Universiteit Brussel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal manual mobilization in people with Dysmenorrhea and Endometriosis, run by Vrije Universiteit Brussel at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barnavol Aurélie (+32486714996, aurelie.barnavol@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.