Effectiveness of Wrist Extensor Strength Training With Blood Flow Restriction on Lateral Elbow Tendinopathy (BFR)

December 1, 2025 updated by: Shahnaz Hasan, PhD, Majmaah University
Repetitive and aggressive injuries to the elbow joint in sports often cause lateral elbow tendinitis (LET). In many clinical settings, therapists follow conventional methods according to their treatment protocols; however, complete rehabilitation is not always implemented. Without adequate care, elbow tendinitis can lead to chronic and recurring elbow injuries. Although many treatments are available, Blood flow restriction training (BFR) is a valuable option for exercise in cases where high-intensity training is too painful or contraindicated. In musculoskeletal disorders, it has been shown to induce hypoalgesia, and positive effects, such as improved muscle strength, growth, and tendon adaptations, have been demonstrated in healthy individuals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Lateral epicondylitis is a work-related musculoskeletal disorder and is defined as persistent symptomatic degeneration of the wrist extensor muscle tendon that connects to the lateral humeral epicondyle. It is characterized by pain on the lateral side of the elbow joint, limited range of motion, and weakness in the forearm muscles.

Management of lateral epicondylitis is aimed at reducing pain and discomfort, preserving ROM, and enhancing the strength and endurance of the affected limb by using numerous techniques, including electrophysical methods and physical activity.

Blood flow restriction training (BFRT) involves partially restricting arterial blood flow into muscles while occluding venous outflow during exercise. It was first introduced into the literature in 1987 by researchers who used tourniquet ischemia to induce fatigue in muscles, dating back to Dr. Yoshiaki Sato in Japan, where it was known as "kaatsu training," meaning "training with added pressure." Kaatsu training is now performed worldwide and is more commonly referred to as "BFR training," which is achieved using a pneumatic tourniquet system.

In addition to physical rehabilitation, BFRT is used for physical training and performance in healthy individuals. There has been extensive research into its value as a training tool, including elite- and amateur-level athletes, untrained young and older adults, and hypertensive individuals.

In addition to reducing arterial blood flow to working muscles, blood flow restriction obstructs venous return. When active muscles are exposed to BFR conditions, they are subjected to ischemia, which increases the metabolic stress on them. In addition to BFR, venous occlusion increases muscle cell swelling, activates intracellular anabolic pathways, and recruits fast-twitch fibers, which are thought to be involved in muscle adaptation.

There were different Factors affecting exercise adaptations with BFR, including pressure of occlusion (partial or complete), type of occlusion (continuous or intermittent), intensity of exercise, and volume of

Exercise with BFR:

BFR, along with low-load resistance training, cardio endurance training, and other activities that are generally recommended to improve muscular mass/strength, is also associated with these adaptations in muscles.

The randomized trial done by Karanasios et al to assess the effect of low-load resistance training with blood flow restriction (LLRT-BFR) versus LLRT with sham-BFR in patients with lateral elbow tendinopathy (LET) found that LLRT with blood flow restriction produced significantly better pain, strength, and function improvement in comparison to LLRT with sham-BFR for all primary outcomes(Karanasios et al., 2022).

Regarding the study of proximal and distal effects of BFR Training, a study by Bowman et al. on Lower extremity Low-load BFR training resulted in greater increases in muscle strength and limb circumference in healthy participants after completing a standardized 6-week course of BFR training. Muscle groups at the proximal and distal ends of the body were similarly strengthened after BFR training(Bowman et al., 2019).

This study aims to explore the effects of incorporating BFR into wrist extensor strength training for athletes with lateral epicondylitis. By evaluating its impact on strength, function, pain, range of motion (ROM), and overall quality of life, this research seeks to determine whether BFR can optimize rehabilitation outcomes and provide a more effective treatment strategy for LET.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Al Riyadh
      • Al Majma'ah, Al Riyadh, Saudi Arabia, 11952
        • Health Rehabiltation Center
    • Al-Riyadh
      • Al Majma'ah, Al-Riyadh, Saudi Arabia, Majmaah University
        • Majmaah University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Both Male and female, aged between 18 to 45 years old.
  2. Subjects with a positive test of lateral epicondylitis, which will be determined based on physical therapy assessment procedures.
  3. The presence of tenderness over the lateral epicondyle.positive Cozen's and Mill's tests.
  4. Pain on grasping.
  5. Pain on passive flexion of the wrist with elbow extension.
  6. Pain with resisted wrist extension.
  7. Show decreased muscle strength and functional ability.

Exclusion Criteria:

  1. Patients with shoulder tendinopathy, cervical radiculopathy, and rheumatoid arthritis.
  2. Presences of sensory and motor impairment of the upper extremities
  3. History of cardiovascular disease
  4. History of trauma and surgery on the elbow
  5. Having a history of malignancy and peripheral vascular disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group: wrist extensor strength training with BFR.
Experimental Group: Participants will undergo wrist extensor strength training with blood flow restriction (BFR).
Behavioral: wrist extensor strength training with BFR.
Wrist extensor strength training without BFR.
Other Names:
  • Wrist extensor strength training without BFR.
Active Comparator: Control Group: Wrist extensor strength training without BFR.
Control Group: Participants will undergo the same wrist extensor strength training without blood flow restriction (BFR).
Behavioral: wrist extensor strength training without BFR.
wrist extensor strength training without BFR.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pressure pain thresholds (PPTs).
Time Frame: six weeks
before and after intervention.
six weeks
pain-free grip strength test
Time Frame: six weeks
before and after intervention.
six weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Borg 6-20 scale
Time Frame: six weeks
Participants will be asked to rate their effort after each set of exercises on a scale from 6 (no exertion) to 20 (maximal exertion).
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Majmaah University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MUR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not yet decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lateral Epicondylitis (Tennis Elbow)

Clinical Trials on wrist extensor strength training with BFR.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings