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Comparison of the Effectiveness of Blood Flow Restriction Exercise and Eccentric Exercise in Lateral Epicondylitis

2 giugno 2026 aggiornato da: Şenol ÇEKMECE, Manisa Celal Bayar University

Comparison of the Effectiveness of Blood Flow Restriction Exercise and Eccentric Exercise in Patients Diagnosed With Lateral Epicondylitis: A Randomized Controlled Trial

This study compared three different treatment approaches for lateral epicondylitis (tennis elbow), a common condition that causes pain on the outside of the elbow.Twenty-seven patients diagnosed with lateral epicondylitis were randomly assigned to one of three treatment groups for 6 weeks:Group 1 - Blood Flow Restriction Exercise (BFRE): Patients performed wrist strengthening exercises using light weights (30% of their maximum capacity) while wearing a pressure cuff on the upper arm that partially restricted blood flow. Sessions were held twice per week under supervision, along with daily stretching exercises and a wrist orthosis.Group 2 - Eccentric Exercise: Patients performed slow lowering (eccentric) wrist exercises using heavier weights (70% of their maximum capacity) five times per week under supervision, along with daily stretching exercises and a wrist orthosis.Group 3 - Orthosis Only: Patients wore a wrist orthosis that held the wrist in a slightly extended position throughout the day and performed daily stretching exercises at home.The main goal was to determine whether blood flow restriction exercise could reduce pain and improve hand function more effectively than eccentric exercise or orthosis use alone. Pain levels, hand grip strength, finger pinch strength, and upper limb function were measured before and after the 6-week treatment period.The study was conducted at Dokuz Eylül University, Department of Orthopedics and Traumatology, İzmir, Turkey.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

27

Fase

  • Non applicabile

Contatti e Sedi

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Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

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Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Sperimentale: 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.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Pain Intensity (Visual Analog Scale)
Lasso di tempo: 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.
Baseline and 6 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Hand Grip Strength
Lasso di tempo: 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.
Baseline and 6 weeks
Change in Pinch Strength
Lasso di tempo: 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.
Baseline and 6 weeks
Change in Upper Extremity Functional Disability (DASH Score)
Lasso di tempo: 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.
Baseline and 6 weeks

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Studia le date principali

Inizio studio (Effettivo)

15 novembre 2021

Completamento primario (Effettivo)

15 ottobre 2024

Completamento dello studio (Effettivo)

20 dicembre 2024

Date di iscrizione allo studio

Primo inviato

21 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 giugno 2026

Primo Inserito (Effettivo)

4 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared to protect participant privacy and confidentiality, in accordance with the institutional review board approval limitations.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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