Dysmenorrhea, Endometriosis
Conditions
Keywords
Dysmenorrhea, endometriosis, Shear wave elastography, Manual therapy, Physiotherapy, Abdominal mobilization, Tissue stiffness, Chronic pelvic pain, Central sensitization, Menstrual pain
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).
Interventions
PROCEDUREAbdominal 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 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.
PROCEDURESham 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.
Sponsors
Vrije Universiteit Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in uterine cervix tissue stiffness measured by shear wave elastography | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Pain will be assessed using a numerical pain scale (ranging from 0 = no pain to 10 = the worst pain imaginable). |
| 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. | SF-36 Short Form questionnaire (0-100 scale, higher scores = better quality of life) |
| Intra- and inter-rater reliability of shear wave elastography measurements | Baseline (Day 0 - Cycle 1). Each cycle lasts between 28 and 31 days. | 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. |
Countries
Belgium
Contacts
CONTACTBarnavol Aurélie
CONTACTSteven Provyn, PhD
STUDY_CHAIRSteven Provyn, PhD
Vrije Universiteit Brussel
STUDY_CHAIRBart Roelands, PhD
Vrije Universiteit Brussel
Outcome results
None listed