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Association Between Menstrual Pain Severity and Plantar Pressure in Young Women

2026年11月9日 更新者:Al Hayah University In Cairo

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.

調査の概要

研究の種類

観察的

入学 (推定)

79

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

      • New Cairo、エジプト
        • 募集
        • Alhayah University in Cairo

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~23年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:CASE_ONLY
  • 時間の展望:CROSS_SECTIONAL

コホートと介入

グループ/コホート
介入・治療
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Static Plantar Pressure Distribution
時間枠: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
時間枠: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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Anterior-Posterior Weight Distribution (%)
時間枠: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 (%)
時間枠: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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年11月18日

一次修了 (推定)

2027年2月1日

研究の完了 (推定)

2027年2月1日

試験登録日

最初に提出

2026年11月9日

QC基準を満たした最初の提出物

2026年11月9日

最初の投稿 (実際)

2026年11月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月13日

QC基準を満たした最後の更新が送信されました

2026年11月9日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • AOMS-PD-PPD-2026-001 Copy

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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