- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07935668
Association Between Menstrual Pain Severity and Plantar Pressure in Young Women
Association Between Primary Dysmenorrhea Severity and Plantar Pressure Distribution in Post-Pubertal Females
Primary dysmenorrhea is a common condition characterized by recurrent menstrual pain in the absence of identifiable pelvic pathology. Menstrual pain may be accompanied by changes in posture, neuromuscular function, and postural control. These changes may influence how body weight is distributed across the feet during standing.
The purpose of this observational study is to investigate the association between primary dysmenorrhea severity and plantar pressure distribution in post-pubertal females.
The study will include 79 female university students aged 18-23 years with a history of primary dysmenorrhea. Participants will be recruited from the first through fourth academic years of the Faculty of Physical Therapy at Al Hayat University in Cairo, Egypt.
Each participant will undergo a single assessment during the menstrual phase, specifically within the first three days of menstruation.
Primary dysmenorrhea severity will be assessed using the Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea (WaLIDD) scale. The scale produces a total score ranging from 0 to 12, with higher scores indicating greater severity.
Plantar pressure distribution will be assessed using the DIERS pedoscan system during standardized barefoot quiet standing. The assessment will include plantar pressure distribution and anterior-posterior and right-left weight distribution.
A minimum of two valid 30-second standing measurements will be obtained and averaged for analysis.
The study will examine whether greater primary dysmenorrhea severity is associated with measurable differences in plantar pressure distribution and weight-bearing characteristics.
No therapeutic intervention, randomization, or experimental treatment allocation will be performed.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Aya O. Mohammed Sobhy
- Número de telefone: +201159880001
- E-mail: aya.osama@ahuc.edu.eg
Locais de estudo
-
-
-
New Cairo, Egito
- Recrutamento
- Alhayah University in Cairo
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
The study population consists of female undergraduate physical therapy students aged 18-23 years attending the first through fourth academic years at Al Hayat University in Cairo, Egypt. Eligible participants will have primary dysmenorrhea, regular menstrual cycles, and the ability to complete a standardized standing plantar pressure assessment. A total of 79 participants is planned. Each participant will be assessed during menstrual Days 1-3.
Descrição
Inclusion Criteria:
- Post-pubertal females aged 18-23 years.
- Regular menstrual cycles ranging from 21 to 35 days.
- History consistent with primary dysmenorrhea for at least the previous six consecutive months.
- Ability to stand independently without assistive devices for the duration of the pedobarographic assessment.
- Provision of written informed consent before participation.
Exclusion Criteria:
- Diagnosis of secondary dysmenorrhea, including endometriosis, adenomyosis, pelvic inflammatory disease, or uterine fibroids, confirmed clinically or through imaging.
- Current or recent pregnancy.
- Neurological disorders affecting balance or sensorimotor function.
- Musculoskeletal injury or condition involving the lower limbs, feet, or lumbar spine within the preceding six months.
- Foot deformity or structural lower-limb abnormality known to alter plantar pressure distribution.
- Current use of medications known to influence postural control, including centrally acting analgesics, benzodiazepines, or antiepileptics.
- History of major lower-limb or foot surgery.
- Systemic disease affecting sensory or motor function, including diabetes mellitus or peripheral neuropathy.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: CASE_ONLY
- Perspectivas de Tempo: CROSS_SECTIONAL
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Post-Pubertal Females With Primary Dysmenorrhea
A single group of 79 post-pubertal females aged 18-23 years with primary dysmenorrhea will be recruited from undergraduate physical therapy students at Al Hayat University in Cairo. Participants will have regular menstrual cycles, a history of primary dysmenorrhea for at least six consecutive months, and the ability to stand independently for pedobarographic assessment. Dysmenorrhea severity and plantar pressure parameters will be assessed at a single visit during menstrual Days 1-3. |
The exposure of interest is the severity of primary dysmenorrhea, quantified using the self-reported WaLIDD scale. The instrument evaluates working ability, pain location, pain intensity, and duration of pain. Each domain contributes 0-3 points to a total score ranging from 0 to 12. Higher scores indicate greater severity. Dysmenorrhea severity will be examined for its association with objectively measured plantar pressure distribution and weight-bearing characteristics during standing. This is an observed characteristic and not an investigator-assigned intervention. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Static Plantar Pressure Distribution
Prazo: Single assessment during menstrual Days 1-3; at least two 30-second standing recordings.
|
Plantar pressure distribution will be assessed using the DIERS pedoscan computerized pedobarographic platform during standardized barefoot quiet standing. Participants will stand with feet shoulder-width apart, arms relaxed at their sides, and eyes directed forward. At least two valid 30-second recordings will be obtained and averaged. The recorded plantar loading distribution will be analyzed in relation to primary dysmenorrhea severity. The precise regional pressure outputs and measurement units must be defined from the study's DIERS reporting protocol before submission. |
Single assessment during menstrual Days 1-3; at least two 30-second standing recordings.
|
|
Primary Dysmenorrhea Severity Assessed by WaLIDD Score
Prazo: Single assessment during menstrual Days 1-3.
|
Primary dysmenorrhea severity will be quantified using the Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea (WaLIDD) scale. The instrument contains four domains, each scored from 0 to 3, resulting in a total score ranging from 0 to 12. Higher scores represent greater symptom severity. Scores are categorized as absent (0), mild (1-4), moderate (5-7), or severe (8-12). The total score will be used as the principal severity variable in the correlational analysis. |
Single assessment during menstrual Days 1-3.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Anterior-Posterior Weight Distribution (%)
Prazo: Single assessment during menstrual Days 1-3; at least two 30-second standing recordings.
|
Anterior-posterior weight distribution will be measured using the DIERS pedoscan system during standardized barefoot quiet standing. The instrument will quantify the distribution of body weight between the anterior and posterior plantar regions, expressed as percentages. At least two valid 30-second recordings will be obtained and averaged for analysis. |
Single assessment during menstrual Days 1-3; at least two 30-second standing recordings.
|
|
Right-Left Weight Distribution (%)
Prazo: Single assessment during menstrual Days 1-3; at least two 30-second standing recordings.
|
Right-left weight distribution will be assessed using the DIERS pedoscan computerized pressure platform. The measurement will quantify the percentage of body weight distributed between the right and left lower limbs during standardized barefoot quiet standing. At least two valid 30-second recordings will be obtained and averaged for analysis. |
Single assessment during menstrual Days 1-3; at least two 30-second standing recordings.
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- AOMS-PD-PPD-2026-001 Copy
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .