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

8 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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).

Tipo de estudo

Intervencional

Inscrição (Estimado)

Estágio

Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Barnavol Aurélie
Número de telefone: +32486714996
E-mail: aurelie.barnavol@vub.be

Estude backup de contato

Nome: Steven Provyn, PhD
Número de telefone: +32475454214

Locais de estudo

Bélgica
- Brussels Capital
  - Brussels, Brussels Capital, Bélgica, 1090
    - Vrije Universiteit Brussel
    - Contato:
      
      Steven Prof. Provyn, PhD
      
      Número de telefone: +475454214
      
      E-mail: steven.Provyn@vub.be
    - Contato:
      
      Aurélie Barnavol
      
      Número de telefone: +32486714996
      
      E-mail: aurelie.barnavol@vub.be
  - Brussels, Brussels Capital, Bélgica, 1160
    - Isek He2B
    - Contato:
      
      Aurélie Barnavol
      
      Número de telefone: +32486714996
      
      E-mail: aurelie.barnavol@vub.be
    - Contato:
      
      Steven Prof. Provyn, PhD
      
      Número de telefone: +32475454214
      
      E-mail: steven.provyn@vub.be

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Finalidade Principal: Tratamento
Alocação: Randomizado
Modelo Intervencional: Atribuição Paralela
Mascaramento: Dobro

Número de braços

Armas e Intervenções

Grupo de Participantes / Braço	Intervenção / Tratamento
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	Procedimento: 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.
Comparador Falso: 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.	Procedimento: 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.

Grupo de Participantes / Braço

Intervenção / Tratamento

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

Procedimento: 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.

Comparador Falso: 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.

Procedimento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Change in uterine cervix tissue stiffness measured by shear wave elastography Prazo: 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 Prazo: 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.

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Change in pain intensity during menstruation Prazo: 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 Prazo: 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 Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Vrije Universiteit Brussel

Investigadores

Cadeira de estudo: Steven Provyn, PhD, Vrije Universiteit Brussel
Cadeira de estudo: Bart Roelands, PhD, Vrije Universiteit Brussel

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de setembro de 2028

Conclusão do estudo (Estimado)

1 de setembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

1 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de junho de 2026

Primeira postagem (Real)

12 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de junho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

26169_DYS ECHO

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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.

Prazo de Compartilhamento de IPD

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

Critérios de acesso de compartilhamento IPD

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.

Tipo de informação de suporte de compartilhamento de IPD

PROTOCOLO DE ESTUDO
CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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