- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07627932
Comparison of the Effectiveness of Blood Flow Restriction Exercise and Eccentric Exercise in Lateral Epicondylitis
Comparison of the Effectiveness of Blood Flow Restriction Exercise and Eccentric Exercise in Patients Diagnosed With Lateral Epicondylitis: A Randomized Controlled Trial
연구 개요
상세 설명
Lateral epicondylitis (tennis elbow) is a musculoskeletal disorder affecting approximately 1-3% of the general population. It is characterized by pain and tenderness at the lateral epicondyle of the elbow due to degenerative changes in the extensor carpi radialis brevis (ECRB) tendon caused by repetitive microtrauma. Conservative treatment options include rest, orthotic devices, physical therapy, and exercise programs.
Eccentric exercise has been widely recommended as a first-line conservative treatment for lateral epicondylitis. However, these programs typically require loading at 70% or more of one-repetition maximum (1-RM), which may not be tolerated by patients experiencing significant pain.
Blood flow restriction exercise (BFRE) is a training method in which a pneumatic cuff is applied to the proximal portion of a limb to partially restrict arterial blood flow and completely restrict venous return during low-load resistance exercise. BFRE has been shown to produce muscle strength and hypertrophy gains at loads as low as 20-40% of 1-RM, making it a potential alternative for patients who cannot tolerate heavy loading. Recent studies have demonstrated the effectiveness of BFRE in various musculoskeletal conditions including osteoarthritis, anterior cruciate ligament reconstruction, and patellar tendinopathy. However, evidence for its use in lateral epicondylitis is limited.
STUDY DESIGN:
This was a prospective, randomized controlled trial with three parallel groups. Patients were allocated using block randomization with blocks of nine.
INTERVENTION PROTOCOLS:
BFRE Group (n=9): Arterial occlusion pressure (AOP) was individually determined using a pneumatic cuff and pulse oximetry. Exercise was performed at 30% of AOP and 30% of 1-RM. Protocol: 3 sets of 15 repetitions with 1-minute rest intervals, twice weekly for 6 weeks. Stretching exercises (3 repetitions x 30 seconds) were performed before and after each session. On non-exercise days, home stretching was performed twice daily. A wrist extension orthosis (15-20 degrees) was worn throughout the study.
Eccentric Exercise Group (n=9): Slow eccentric wrist extensor exercises were performed with the elbow in full extension and forearm in pronation. The weight was lowered from wrist extension to flexion over approximately 30 seconds. Protocol: 3 sets of 10 repetitions with 1-minute rest intervals, five times weekly for 6 weeks, at 70% of 1-RM. Stretching and orthosis protocols were identical to the BFRE group.
Orthosis Group (n=9): Participants wore a wrist extension orthosis maintaining 15-20 degrees of extension throughout the day, removing it only during sleep, bathing, and stretching exercises. Stretching exercises were performed twice daily (3 repetitions x 30 seconds).
Exercise protocols were kept constant throughout the 6-week intervention period without progression. All supervised sessions were conducted at Dokuz Eylül University. Patients received illustrated exercise booklets and maintained exercise diaries to monitor home program adherence.
SAMPLE SIZE JUSTIFICATION:
Sample size was calculated using G*Power (version 3.1.9.4) with the following parameters: effect size 1.8, Type I error rate alpha = 0.05, and 95% statistical power, yielding a minimum of 9 participants per group (total N = 27).
STATISTICAL ANALYSIS:
Data were analyzed using SPSS version 20.0. Normality was assessed using the Shapiro-Wilk test. Baseline comparisons used one-way ANOVA. Within-group pre-post comparisons used paired t-tests. Between-group differences and time-by-group interactions were evaluated using mixed model ANOVA with post-hoc analyses. Significance was set at p < 0.05.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Izmir, 터키 (Türkiye), 3500
- Dokuz Eylul University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Clinical diagnosis of lateral epicondylitis confirmed by physical examination
- Provision of written informed consent
Exclusion Criteria:
- Bilateral lateral epicondylitis
- Cervical radiculopathy
- History of elbow, forearm, or wrist pathology (previous elbow surgery, tendon rupture, fracture of the humerus/radius/ulna, osteoporosis, neurological involvement, or nerve paralysis)
- Physiotherapy within the preceding 6 weeks
- Tumor
- Cardiac arrhythmia, pacemaker use, coagulation disorders, anticoagulant therapy, or history of deep vein thrombosis
- Systemic or neurological disease
- Peripheral vascular disease or endothelial dysfunction
- Conditions associated with endothelial dysfunction, including uncontrolled hypertension, cardiovascular disease, systemic inflammation, obesity, diabetes, or atherosclerosis
- Active infection
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: Eccentric exercise
The eccentric exercise protocol involved slow eccentric wrist extensor exercises with the elbow in full extension and the forearm in pronation.
From a wrist extension position, participants slowly lowered the weight into flexion over approximately 30 seconds.
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The eccentric exercise protocol involved slow eccentric wrist extensor exercises with the elbow in full extension and the forearm in pronation.
From a wrist extension position, participants slowly lowered the weight into flexion over approximately 30 seconds.
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실험적: Blood flow restriction
Participants in the Blood flow restriction group performed low-load wrist extensor strengthening exercises with blood flow restriction twice weekly for 6 weeks.
Arterial occlusion pressure was individually determined using a pneumatic cuff and pulse oximetry.
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Participants in the BFRE group performed low-load wrist extensor strengthening exercises with blood flow restriction twice weekly for 6 weeks.
Arterial occlusion pressure was individually determined using a pneumatic cuff and pulse oximetry.
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활성 비교기: Orthosis
The orthosis group served as the reference standard conservative treatment group.
Participants wore a wrist extension orthosis maintaining 15-20° of extension throughout the day, removing it only during sleep, bathing, and stretching exercises.
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The orthosis group served as the reference standard conservative treatment group.
Participants wore a wrist extension orthosis maintaining 15-20° of extension throughout the day, removing it only during sleep, bathing, and stretching exercises.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Pain Intensity (Visual Analog Scale)
기간: Baseline and 6 weeks
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Pain intensity was assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line where 0 represents "no pain" and 10 represents "worst imaginable pain."
Patients marked the point corresponding to their current pain level.
Change was calculated as the difference between baseline and post-treatment scores.
A negative change indicates pain reduction.
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Baseline and 6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Hand Grip Strength
기간: Baseline and 6 weeks
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Hand grip strength was measured using a JAMAR hydraulic hand dynamometer (kg).
Measurements were performed in a standardized position with the elbow at 90 degrees of flexion and the forearm in neutral position.
The mean of three consecutive trials was recorded.
A positive change indicates strength improvement.
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Baseline and 6 weeks
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Change in Pinch Strength
기간: Baseline and 6 weeks
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Pinch strength was measured using a pinch meter (kg).
Three types of pinch grip were assessed: lateral pinch, palmar pinch, and tip-to-tip pinch.
The mean of three trials across all pinch types was recorded.
A positive change indicates strength improvement.
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Baseline and 6 weeks
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Change in Upper Extremity Functional Disability (DASH Score)
기간: Baseline and 6 weeks
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Upper extremity functional disability was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
The DASH consists of 30 items scored from 0 (no disability) to 100 (maximum disability).
A negative change indicates functional improvement.
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Baseline and 6 weeks
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Takarada Y, Takazawa H, Sato Y, Takebayashi S, Tanaka Y, Ishii N. Effects of resistance exercise combined with moderate vascular occlusion on muscular function in humans. J Appl Physiol (1985). 2000 Jun;88(6):2097-106. doi: 10.1152/jappl.2000.88.6.2097.
- Kohia M, Brackle J, Byrd K, Jennings A, Murray W, Wilfong E. Effectiveness of physical therapy treatments on lateral epicondylitis. J Sport Rehabil. 2008 May;17(2):119-36. doi: 10.1123/jsr.17.2.119.
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- ManisaCelalBayarU
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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