- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07620678
Comparison of ESWT and Single-Session 5% Dextrose Prolotherapy in Lateral Epicondylitis
Comparison of the Effectiveness of Extracorporeal Shock Wave Therapy and 5% Dextrose Prolotherapy in Patients With Lateral Epicondylitis: A Prospective Randomized Controlled Trial
연구 개요
상태
상세 설명
Lateral epicondylitis is a common musculoskeletal disorder associated with pain, reduced grip strength, and impaired upper extremity function. This study aimed to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and single-session 5% dextrose prolotherapy (DPT) in patients with lateral epicondylitis and to evaluate their relative effectiveness during short- and mid-to-long-term follow-up.
Ninety-six patients were allocated into three groups: conventional treatment alone, conventional treatment plus ESWT, and conventional treatment plus DPT. Conventional treatment consisted of home exercise and splinting. ESWT was applied in 3 sessions (2000 pulses, 0.15 mJ/mm²), while the DPT group received a single ultrasound-guided 5% dextrose injection.
Primary outcomes included Visual Analog Scale pain scores for rest, night pain, resisted wrist extension, and grip pain. Secondary outcomes included QuickDASH, PRTEE, grip strength measured with a Jamar dynamometer, and ultrasonographic assessment of common extensor tendon thickness. Clinical assessments were performed at baseline, 1, 3, and 6 months.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Cankaya
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Ankara, Cankaya, 터키 (Türkiye)
- SBU Ankara Physical Medicine and Rehabilitation Training and Research Hospital Ankara, Turkey
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 18-75 years
- Clinical and ultrasonographic diagnosis of lateral epicondylitis
- Symptoms persisting for at least 3 months
- Visual Analog Scale (VAS) score ≥4
- Resistance to previous medical treatment
- Ability to comply with study procedures and complete questionnaires
Exclusion Criteria:
- Injection treatment for lateral epicondylitis within the previous 3 months
- History of trauma within the previous 3 months
- Cervical disc herniation
- Median or ulnar tunnel neuropathy
- Medial epicondylitis
- Anticoagulant therapy use
- Pregnancy or breastfeeding
- Psychiatric disorders or cognitive impairment interfering with questionnaire -completion
- Allergy to the treatment solution
- History of upper extremity surgery or fracture
- Rheumatoid arthritis
- Connective tissue diseases such as dermatomyositis
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Conventional Treatment + ESWT
Three treatment sessions administered at weekly intervals using 2000 pulses per session at an energy flux density of 0.15 mJ/mm².
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Splinting and home exercise program
3 sessions, weekly, 4Hz, 2000 pulses/session, 0.15 mJ/mm².
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활성 비교기: Conventional Treatment + Dextrose Prolotherapy
Single-session ultrasound-guided injection of 1 mL 5% dextrose.
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Splinting and home exercise program
Single-session ultrasound-guided 1 mL 5% dextrose injection.
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활성 비교기: Conventional Treatment
Splinting and home exercise program.
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Splinting and home exercise program
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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VAS Resisted Wrist Extension Pain
기간: Baseline, 1 month, 3 months, and 6 months after treatment
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Pain during resisted wrist extension assessed using the Visual Analog Scale (VAS).
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Baseline, 1 month, 3 months, and 6 months after treatment
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VAS Gripping Pain
기간: Baseline, 1 month, 3 months, and 6 months after treatment
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Pain intensity during gripping assessed using the Visual Analog Scale (VAS).
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Baseline, 1 month, 3 months, and 6 months after treatment
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VAS Resting Pain
기간: Baseline, 1 month, 3 months, and 6 months after treatment
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Resting pain assessed using the Visual Analog Scale (VAS).
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Baseline, 1 month, 3 months, and 6 months after treatment
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VAS Night Pain
기간: Baseline, 1 month, 3 months, and 6 months after treatment
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Night pain assessed using the Visual Analog Scale (VAS).
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Baseline, 1 month, 3 months, and 6 months after treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quick-DASH Score
기간: Baseline, 1 month, 3 months, and 6 months after treatment
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Functional disability assessed using the Quick Disabilities of the Arm, Shoulder and Hand questionnaire.
The QuickDASH score ranges from 0 to 100, where 0 indicates no symptoms and normal upper extremity function, while 100 indicates the highest symptom severity and the poorest functional status.
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Baseline, 1 month, 3 months, and 6 months after treatment
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PRTEE Score
기간: Baseline, 1 month, 3 months, and 6 months after treatment
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Functional outcome assessed using the Patient-Rated Tennis Elbow Evaluation questionnaire.
The PRTEE consists of 15 items divided into two subscales: pain (5 items) and function (10 items).
The total score ranges from 0 to 100, with 0 indicating no pain and normal function, and 100 indicating the highest pain severity and the poorest functional status.
Higher scores reflect greater pain intensity and functional impairment.
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Baseline, 1 month, 3 months, and 6 months after treatment
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Grip Strength
기간: Baseline and 6 months
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Grip strength measured using a Jamar dynamometer.
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Baseline and 6 months
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Common Extensor Tendon Thickness
기간: Baseline and 6 months
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Ultrasonographic measurement of common extensor tendon thickness.
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Baseline and 6 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- E1-23-4037
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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