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

Browse trials for

• Dysmenorrhea 430
• Endometriosis 920

Keywords

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

Dysmenorrhea

430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.

This study's planned enrollment of 80 is above the median of 62 across 363 interventional studies indexed under Dysmenorrhea.

Lead sponsor

Vrije Universiteit Brussel is the lead sponsor of 158 studies on the registry; 43 are open to participants now.

Study arms

• Experimental
  Manual Abdominal Mobilization

  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 comparator
  Sham Manual Therapy

  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

• 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.

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.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Informed consent form

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.