- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07936448
Effect Of Shock Waves Therapy On Post Natal De Quarvain Tenosynovitis
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Mai Kamel Anwar, B.Sc
- 전화번호: 01001813906
- 이메일: Maikamel905@gmail.com
연구 연락처 백업
- 이름: Elham Shahat Hassan, PhD
연구 장소
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Giza, 이집트
- Kasr El Ainy University Hospital
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연락하다:
- Mai Kamel Anwar, B.Sc
- 전화번호: 01001813906
- 이메일: Maikamel905@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Women in the postpartum period of > 6 months following labor
- Age: Between 25 and 35 years old.
- Body mass index: Between 25-30 kg / m2
- Diagnosis: Clinically diagnosed with De Quervain tenosynovitis by an orthopedic specialist or confirmed through clinical evaluation.
- Pain Severity: Presenting with moderate to severe pain (≥ 4 on the Visual Analogue Scale).
- Obstetric History: Multipara women (Cesarean section or normal labor)
- Stage of Condition Chronic stage: symptoms > 6 weeks
Exclusion Criteria:
- Previous Surgery: History of surgical intervention on the affected wrist or thumb.
- Skin Conditions: Open wounds, infections, or dermatological diseases at the application site that may interfere with shockwave therapy.
- Pregnancy: Pregnant or lactating women.
- Medication Use: Currently taking systemic corticosteroids, anticoagulants, or nonsteroidal anti-inflammatory drugs (NSAIDs) that may influence study outcomes.
- Pacemaker or Metal Implants: Presence of a cardiac pacemaker or metal implants near the treatment area.
- Other Physiotherapy: Receiving concurrent physiotherapy treatment for the same condition during the study period.
- Non-compliance: Inability or unwillingness to attend treatment sessions or follow instructions throughout the study duration.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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. |
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활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Intensity Measured by Visual Analogue Scale (VAS)
기간: 4 weeks
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Wrist Flexion Range of Motion
기간: 4 weeks
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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
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Wrist Extension Range of Motion
기간: 4 weeks
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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
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Wrist Radial Deviation Range of Motion
기간: 4 weeks
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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
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Wrist Ulnar Deviation Range of Motion
기간: 4 weeks
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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
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Thumb Flexion Range of Motion
기간: 4 weeks
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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
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Thumb Extension Range of Motion
기간: 4 weeks
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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
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Thumb Abduction Range of Motion
기간: 4 weeks
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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
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Thumb Adduction Range of Motion
기간: 4 weeks
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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
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Upper Limb Disability Measured by DASH Questionnaire
기간: 4 weeks
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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
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공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Hala Mohamed Hanafy, PhD, Professor, Cairo University
- 연구 책임자: Sameh Hussien Samir, PhD, Professor, National Research Centre
- 연구 책임자: Elham Shahat Hassan, PhD, Ass. Professor, Cairo University
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
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