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

8. juni 2026 oppdatert av: Vrije Universiteit Brussel

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Steven Provyn, PhD
  • Telefonnummer: +32475454214

Studiesteder

  • Belgia
    • Brussels Capital
      • Brussels, Brussels Capital, Belgia, 1090
        • Vrije Universiteit Brussel
        • Ta kontakt med:
        • Ta kontakt med:
      • Brussels, Brussels Capital, Belgia, 1160

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Fremgangsmåte: Abdominal 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.
Sham-komparator: 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.
Fremgangsmåte: Sham 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in uterine cervix tissue stiffness measured by shear wave elastography
Tidsramme: 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).
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
Tidsramme: 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.
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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in pain intensity during menstruation
Tidsramme: 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).
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
Tidsramme: 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)
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
Tidsramme: 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.
Baseline (Day 0 - Cycle 1). Each cycle lasts between 28 and 31 days.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Vrije Universiteit Brussel

Etterforskere

  • Studiestol: Steven Provyn, PhD, Vrije Universiteit Brussel
  • Studiestol: Bart Roelands, PhD, Vrije Universiteit Brussel

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. september 2028

Studiet fullført (Antatt)

1. september 2028

Datoer for studieregistrering

Først innsendt

1. juni 2026

Først innsendt som oppfylte QC-kriteriene

8. juni 2026

Først lagt ut (Faktiske)

12. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 26169_DYS ECHO

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Start date: Beginning 6 months after publication of the main results. End date: Ending 5 years after publication of the main results

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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