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Effect Of Shock Waves Therapy On Post Natal De Quarvain Tenosynovitis

2026年11月7日 更新者:Mai Kamel Anwar、Cairo University

This randomized controlled trial aims to investigate the effect of extracorporeal shock wave therapy (ESWT) on pain, wrist and thumb range of motion, and upper limb function in postpartum women with De Quervain's tenosynovitis.

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

De Quervain's tenosynovitis is a musculoskeletal condition affecting the abductor pollicis longus and extensor pollicis brevis tendons within the first dorsal compartment of the wrist. It is associated with pain, tenderness, restricted thumb and wrist movement, and difficulty performing daily activities. Postpartum women may be particularly affected because of repetitive wrist and thumb movements associated with infant care.

Extracorporeal shock wave therapy (ESWT) is a non-invasive treatment modality being investigated for its potential effects on pain reduction and functional recovery in musculoskeletal disorders.

This study is designed as a prospective randomized controlled trial involving 40 postpartum women diagnosed with De Quervain's tenosynovitis. Participants will be randomly allocated into two equal groups of 20 women each.

The study group will receive extracorporeal shock wave therapy combined with a therapeutic exercise program consisting of tendon gliding, stretching, and strengthening exercises.

The control group will receive the same therapeutic exercise program without shock wave therapy.

Outcome assessments will be conducted before and after the treatment period. Pain intensity will be evaluated using the Visual Analogue Scale (VAS), wrist and thumb range of motion will be measured using a goniometer, and upper limb function will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.

The study will compare changes within and between the two groups to evaluate the additional effect of shock wave therapy on pain, range of motion, and upper limb function in postpartum women with De Quervain's tenosynovitis.

研究の種類

介入

入学 (推定)

40

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

研究連絡先のバックアップ

  • 名前:Elham Shahat Hassan, PhD

研究場所

      • Giza、エジプト
        • Kasr El Ainy University Hospital
        • コンタクト:

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

25年~35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

説明

Inclusion Criteria:

  1. Women in the postpartum period of > 6 months following labor
  2. Age: Between 25 and 35 years old.
  3. Body mass index: Between 25-30 kg / m2
  4. Diagnosis: Clinically diagnosed with De Quervain tenosynovitis by an orthopedic specialist or confirmed through clinical evaluation.
  5. Pain Severity: Presenting with moderate to severe pain (≥ 4 on the Visual Analogue Scale).
  6. Obstetric History: Multipara women (Cesarean section or normal labor)
  7. Stage of Condition Chronic stage: symptoms > 6 weeks

Exclusion Criteria:

  1. Previous Surgery: History of surgical intervention on the affected wrist or thumb.
  2. Skin Conditions: Open wounds, infections, or dermatological diseases at the application site that may interfere with shockwave therapy.
  3. Pregnancy: Pregnant or lactating women.
  4. Medication Use: Currently taking systemic corticosteroids, anticoagulants, or nonsteroidal anti-inflammatory drugs (NSAIDs) that may influence study outcomes.
  5. Pacemaker or Metal Implants: Presence of a cardiac pacemaker or metal implants near the treatment area.
  6. Other Physiotherapy: Receiving concurrent physiotherapy treatment for the same condition during the study period.
  7. Non-compliance: Inability or unwillingness to attend treatment sessions or follow instructions throughout the study duration.

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:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Shock Wave Therapy + Therapeutic Exercises

Twenty postpartum women with De Quervain's tenosynovitis will receive extracorporeal shock wave therapy (ESWT) in addition to a therapeutic exercise program consisting of tendon gliding, stretching, and strengthening exercises. The exercise program will be performed for 30 minutes daily over four weeks.

Extracorporeal shock wave therapy will be applied to the affected first dorsal compartment of the wrist using a radial shock wave device. Treatment parameters will include 1,000 impulses per session, with frequencies ranging from 18 to 21 Hz and pressure settings ranging from 1.4 to 1.8 bar, according to the study protocol.

他の名前:
  • Extracorporeal Shock Wave Therapy (ESWT)

A structured therapeutic exercise program consisting of tendon gliding, stretching, active range-of-motion exercises, and progressive strengthening exercises targeting the wrist and thumb. Exercises will be performed for 30 minutes daily over four weeks, according to participants' tolerance.

アクティブコンパレータ:Therapeutic Exercises

Twenty postpartum women with De Quervain's tenosynovitis will receive a therapeutic exercise program consisting of tendon gliding, stretching, and strengthening exercises for 30 minutes daily over four weeks, without shock wave therapy.

A structured therapeutic exercise program consisting of tendon gliding, stretching, active range-of-motion exercises, and progressive strengthening exercises targeting the wrist and thumb. Exercises will be performed for 30 minutes daily over four weeks, according to participants' tolerance.

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
Pain Intensity Measured by Visual Analogue Scale (VAS)
時間枠:4 weeks

Pain intensity will be measured using a 10-cm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate less pain. Changes in pain intensity will be compared between the study and control groups.

4 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Wrist Flexion Range of Motion
時間枠:4 weeks

Change in active wrist flexion range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement.

4 weeks
Wrist Extension Range of Motion
時間枠:4 weeks

Change in active wrist extension range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement.

4 weeks
Wrist Radial Deviation Range of Motion
時間枠:4 weeks

Change in active wrist radial deviation range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement.

4 weeks
Wrist Ulnar Deviation Range of Motion
時間枠:4 weeks

Change in active wrist ulnar deviation range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement.

4 weeks
Thumb Flexion Range of Motion
時間枠:4 weeks

Change in active thumb flexion range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement.

4 weeks
Thumb Extension Range of Motion
時間枠:4 weeks

Change in active thumb extension range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement.

4 weeks
Thumb Abduction Range of Motion
時間枠:4 weeks

Change in active thumb abduction range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement.

4 weeks
Thumb Adduction Range of Motion
時間枠:4 weeks

Change in active thumb adduction range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement.

4 weeks
Upper Limb Disability Measured by DASH Questionnaire
時間枠:4 weeks

Upper limb function and disability will be assessed using the 30-item Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The total score ranges from 0 (no disability) to 100 (maximum disability). Lower scores indicate better upper limb function.

4 weeks

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

捜査官

  • スタディチェア:Hala Mohamed Hanafy, PhD、Professor, Cairo University
  • スタディディレクター:Sameh Hussien Samir, PhD、Professor, National Research Centre
  • スタディディレクター:Elham Shahat Hassan, PhD、Ass. Professor, Cairo University

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20日

一次修了 (推定)

2027年1月20日

研究の完了 (推定)

2027年1月31日

試験登録日

最初に提出

2026年11月7日

QC基準を満たした最初の提出物

2026年11月7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7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

  • P.T.REC/012/006319

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