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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Aya O. Mohammed Sobhy
- 전화번호: +201159880001
- 이메일: aya.osama@ahuc.edu.eg
연구 장소
-
-
-
New Cairo, 이집트
- 모병
- Alhayah University in Cairo
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: CROSS_SECTIONAL
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Static Plantar Pressure Distribution
기간: 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
기간: 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.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Anterior-Posterior Weight Distribution (%)
기간: 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 (%)
기간: 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.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- AOMS-PD-PPD-2026-001 Copy
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .