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Lateral EpicondylitisNCT07627932

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

A study testing Blood flow restriction, Eccentric Exercise and Orthosis in people with Lateral Epicondylitis, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lateral Epicondylitis
What is being tested?
Blood flow restriction, Eccentric Exercise and Orthosis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Nov 2021to 20 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of lateral epicondylitis confirmed by physical examination
  • Provision of written informed consent

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Dokuz Eylül University

    Izmir, 3500

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Blood flow restriction, Eccentric Exercise, Orthosis
Keywords
Lateral epicondylitis, Blood flow restriction exercise, Eccentric exercise, Tennis elbow, Rehabilitation
Medical subject headings
Tennis Elbow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood flow restrictionOther

    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 ExerciseOther

    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.

  • OrthosisOther

    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.

Study groups in NCT07627932
Study groupRoleWhat they receive
Eccentric exerciseActive comparatorThe 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.
Receives: Other: Eccentric Exercise
Blood flow restrictionExperimentalParticipants 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.
Receives: Other: Blood flow restriction
OrthosisActive comparatorThe 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.
Receives: Other: Orthosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pain Intensity (Visual Analog Scale)

    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.

    Measured: Baseline and 6 weeks

Secondary outcomes (3)
  1. Change in Hand Grip Strength

    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.

    Measured: Baseline and 6 weeks

  2. Change in Pinch Strength

    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.

    Measured: Baseline and 6 weeks

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

    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.

    Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2026
  2. Study start15 Nov 2021
  3. Primary completion15 Oct 2024
  4. Study completion20 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07627932
Sponsor's protocol ID
ManisaCelalBayarU
Status last verified
Jun 2026
First submitted
21 May 2026
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared to protect participant privacy and confidentiality, in accordance with the institutional review board approval limitations.

Publications

  • 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.

    PubMed 10846023
  • 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.

    PubMed 18515912

Questions about this trial

What is this clinical trial studying?

A study testing Blood flow restriction, Eccentric Exercise and Orthosis in people with Lateral Epicondylitis, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Intensity (Visual Analog Scale) (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07627932, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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