- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Izmir, Turkki (Türkiye), 3500
- Dokuz Eylul University
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: 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.
|
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.
|
|
Kokeellinen: 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.
|
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.
|
|
Active Comparator: 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.
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Pain Intensity (Visual Analog Scale)
Aikaikkuna: Baseline and 6 weeks
|
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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Hand Grip Strength
Aikaikkuna: Baseline and 6 weeks
|
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
Aikaikkuna: Baseline and 6 weeks
|
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)
Aikaikkuna: Baseline and 6 weeks
|
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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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Kyynärpään tendinopatia
- Kyynärpään vammat
- Tuki- ja liikuntaelinten sairaudet
- Lihassairaudet
- Haavat ja vammat
- Jänteiden vammat
- Käsien vammat
- Tendinopatia
- Tenniskyynärpää
- Terapeuttiset lääkkeet
- Fysioterapiatapa
- Ortopediset laitteet
- Kirurginen laite
- Laitteet ja tarvikkeet
- Potilashoito
- Liikuntahoito
- Kuntoutus
- Jälkihoito
- Potilaan hoidon jatkuvuus
- Verenvirtaushoito
- Ortosilaite
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- ManisaCelalBayarU
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Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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