Trigger Point Extracorporeal Shock Wave Therapy in Patients With Lateral Epicondylitis (LE-TP-ESWT)
The Effect of Extracorporeal Shock Wave Therapy Applied to the Trigger Point on Grip Strength, Visual Analog Scale Score, and Common Extensor Tendon Thickness in Patients With Lateral Epicondylitis
연구 개요
상태
상세 설명
Lateral epicondylitis is a common tendinopathic condition characterized by pain over the lateral elbow, reduced grip strength, and limitation in upper extremity function. The extensor carpi radialis brevis tendon and the common extensor tendon origin are frequently involved. Myofascial trigger points in the extensor carpi radialis brevis muscle may also contribute to pain and functional impairment.
This prospective randomized controlled single-blind study investigates whether extracorporeal shock wave therapy applied to the extensor carpi radialis brevis trigger point provides additional clinical and ultrasonographic benefit in patients with lateral epicondylitis. Participants are allocated to two parallel groups. Both groups receive active extracorporeal shock wave therapy to the lateral epicondyle region once weekly for three sessions. The intervention group also receives active extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle. The comparator group receives sham extracorporeal shock wave therapy to the same trigger point area.
Outcome assessments are performed at baseline and at week 4. Pain intensity is assessed using the Visual Analog Scale. Grip strength is measured with a Jamar hand dynamometer. Hand function is assessed using the Duruöz Hand Index. Common extensor tendon thickness is measured by ultrasonography. The primary aim is to determine whether active trigger point extracorporeal shock wave therapy provides additional improvement compared with sham trigger point application when both groups receive active treatment to the lateral epicondyle region.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ankara
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Ankara, Ankara, 터키 (Türkiye), 06560
- Gazi University Faculty of Medicine Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age between 18 and 50 years
- Clinical diagnosis of lateral epicondylitis
- Tenderness over the lateral epicondyle
- Presence of trigger point in the extensor carpi radialis brevis muscle
- Ability to provide written informed consent
Exclusion Criteria:
- Peripheral nerve disease involving the ulnar, median, or radial nerve
- Other elbow pathologies such as instability, arthritis, or dermatologic lesions
- Radicular pain
- Previous elbow surgery
- Platelet-rich plasma injection, stem cell injection, corticosteroid injection, or extracorporeal shock wave therapy to the affected elbow within the previous month
- Presence of a pacemaker
- Pregnancy
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: Active Trigger Point ESWT Group
Participants receive active extracorporeal shock wave therapy to the lateral epicondyle region and active extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle, once weekly for three sessions.
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Active extracorporeal shock wave therapy is applied to the lateral epicondyle region in both groups once weekly for three sessions.
In the experimental group, active extracorporeal shock wave therapy is also applied to one trigger point in the extensor carpi radialis brevis muscle.
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가짜 비교기: Sham Trigger Point ESWT Group
Participants receive active extracorporeal shock wave therapy to the lateral epicondyle region and sham extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle, once weekly for three sessions.
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Active extracorporeal shock wave therapy is applied to the lateral epicondyle region in both groups once weekly for three sessions.
In the experimental group, active extracorporeal shock wave therapy is also applied to one trigger point in the extensor carpi radialis brevis muscle.
Sham extracorporeal shock wave therapy is applied to one trigger point in the extensor carpi radialis brevis muscle using a sham applicator that produces a similar sound but does not deliver therapeutic shock wave energy.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Common Extensor Tendon Thickness
기간: Baseline and week 4
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Common extensor tendon thickness is measured by ultrasonography using a linear probe with the elbow flexed at 90 degrees and the forearm in mid-supination.
Measurements are performed on a longitudinal image at the lateral epicondyle region, perpendicular to the tendon fibers.
The change from baseline to week 4 is evaluated
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Baseline and week 4
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Pain Intensity Assessed by Visual Analog Scale
기간: Baseline and week 4
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Pain intensity is assessed using a 10-cm Visual Analog Scale.
A score of 0 indicates no pain and a score of 10 indicates the worst pain.
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Baseline and week 4
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Change in Grip Strength
기간: Baseline and week 4
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Grip strength is measured using a Jamar hand dynamometer.
Measurements are performed with the participant seated, the shoulder adducted, the elbow flexed at 90 degrees, the forearm in neutral position, and the wrist in neutral position.
Three consecutive measurements are obtained from the affected side, and the mean value is used for analysis.
The change from baseline to week 4 is evaluated.
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Baseline and week 4
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Change in Functional Disability Assessed by the Duruöz Hand Index
기간: Baseline and week 4
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functional disability is assessed using the Duruöz Hand Index.
The scale includes 18 items evaluating difficulties in daily activities involving hand use.
Total scores range from 0 to 90, with higher scores indicating greater disability.
The change from baseline to week 4 is evaluated.
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Baseline and week 4
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- LE-ESWT-ECRB-2026
- KD24/04 (기타 식별자: Başkent University Clinical Research Ethics Committee)
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
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Extracorporeal Shock Wave Therapy에 대한 임상 시험
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Indústria Brasileira Equipamentos Médicos - IBRAMED완전한