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NCT Number: NCT07627932

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylül University

Izmir, 3500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Flow Restriction

Other

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.

Eccentric exercise

Other

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.

Orthosis

Other

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.

Primary outcomes

  1. Change in Pain Intensity (Visual Analog Scale)

    Time frame: 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.

Secondary outcomes

  1. Change in Hand Grip Strength

    Time frame: 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.

  2. Change in Pinch Strength

    Time frame: 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.

  3. Change in Upper Extremity Functional Disability (DASH Score)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Manisa Celal Bayar University

Other

Collaborators

  • Dokuz Eylul University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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