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

2026年6月8日更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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).

研究の種類

介入

入学 (推定)

段階

適用できない

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

名前：Barnavol Aurélie
電話番号：+32486714996
メール：aurelie.barnavol@vub.be

研究連絡先のバックアップ

名前：Steven Provyn, PhD
電話番号：+32475454214

研究場所

ベルギー
- Brussels Capital
  - Brussels、Brussels Capital、ベルギー、1090
    - Vrije Universiteit Brussel
    - コンタクト：
      
      Steven Prof. Provyn, PhD
      
      電話番号：+475454214
      
      メール：steven.Provyn@vub.be
    - コンタクト：
      
      Aurélie Barnavol
      
      電話番号：+32486714996
      
      メール：aurelie.barnavol@vub.be
  - Brussels、Brussels Capital、ベルギー、1160
    - Isek He2B
    - コンタクト：
      
      Aurélie Barnavol
      
      電話番号：+32486714996
      
      メール：aurelie.barnavol@vub.be
    - コンタクト：
      
      Steven Prof. Provyn, PhD
      
      電話番号：+32475454214
      
      メール：steven.provyn@vub.be

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

大人

健康ボランティアの受け入れ

はい

説明

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

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

主な目的：処理
割り当て：ランダム化
介入モデル：並列代入
マスキング：ダブル

アーム数

武器と介入

参加者グループ / アーム	介入・治療
実験的：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	手順：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.
偽コンパレータ：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.	手順：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.

参加者グループ / アーム

介入・治療

実験的：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

手順：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.

偽コンパレータ：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.

手順：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.

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
Change in uterine cervix tissue stiffness measured by shear wave elastography 時間枠：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 時間枠：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.

二次結果の測定

結果測定	メジャーの説明	時間枠
Change in pain intensity during menstruation 時間枠：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 時間枠：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 時間枠：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.

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。

スポンサー

Vrije Universiteit Brussel

捜査官

スタディチェア：Steven Provyn, PhD、Vrije Universiteit Brussel
スタディチェア：Bart Roelands, PhD、Vrije Universiteit Brussel

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9月1日

一次修了 (推定)

2028年9月1日

研究の完了 (推定)

2028年9月1日

試験登録日

最初に提出

2026年6月1日

QC基準を満たした最初の提出物

2026年6月8日

最初の投稿 (実際)

2026年6月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月12日

QC基準を満たした最後の更新が送信されました

2026年6月8日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

26169_DYS ECHO

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?

はい

IPD プランの説明

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 共有時間枠

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

IPD 共有アクセス基準

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 共有サポート情報タイプ

STUDY_PROTOCOL
ICF

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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