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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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名:Elham Shahat Hassan, PhD

学习地点

      • Giza、埃及
        • Kasr El Ainy University Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

25年 至 35年 (成人)

接受健康志愿者

不

有资格学习的性别

女性

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

其他名称:
  • 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.

有源比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Pain Intensity Measured by Visual Analogue Scale (VAS)
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Wrist Flexion Range of Motion
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Hala Mohamed Hanafy, PhD、Professor, Cairo University
  • 研究主任:Sameh Hussien Samir, PhD、Professor, National Research Centre
  • 研究主任:Elham Shahat Hassan, PhD、Ass. Professor, Cairo University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月20日

初级完成 (估计的)

2027年1月20日

研究完成 (估计的)

2027年1月31日

研究注册日期

首次提交

2026年11月7日

首先提交符合 QC 标准的

2026年11月7日

首次发布 (实际的)

2026年11月13日

研究记录更新

最后更新发布 (实际的)

2026年11月13日

上次提交的符合 QC 标准的更新

2026年11月7日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

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研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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