Lateral Epicondylitis (Tennis Elbow)BFRNCT07007455
Effectiveness of Wrist Extensor Strength Training With Blood Flow Restriction on Lateral Elbow Tendinopathy
A study testing wrist extensor strength training with BFR. and wrist extensor strength training without BFR. in people with Lateral Epicondylitis (Tennis Elbow) and Elbow Pain, run by Majmaah University at 2 sites in Saudi Arabia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Lateral Epicondylitis (Tennis Elbow), Elbow Pain, Lateral Elbow Tendinopathy
- What is being tested?
- wrist extensor strength training with BFR. and wrist extensor strength training without BFR.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 15 Feb 2025to 25 May 2025
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both Male and female, aged between 18 to 45 years old.
- Subjects with a positive test of lateral epicondylitis, which will be determined based on physical therapy assessment procedures.
- The presence of tenderness over the lateral epicondyle.positive Cozen's and Mill's tests.
- Pain on grasping.
- Pain on passive flexion of the wrist with elbow extension.
- Pain with resisted wrist extension.
- Show decreased muscle strength and functional ability.
Who cannot join
- Patients with shoulder tendinopathy, cervical radiculopathy, and rheumatoid arthritis.
- Presences of sensory and motor impairment of the upper extremities
- History of cardiovascular disease
- History of trauma and surgery on the elbow
- Having a history of malignancy and peripheral vascular disorders.
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
Health Rehabiltation Center
Al Majma'ah, Al Riyadh, 11952
Majmaah University
Al Majma'ah, Al-Riyadh, Majmaah University
About this study
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.
Read the 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.
- Conditions
- Lateral Epicondylitis (Tennis Elbow), Elbow Pain, Lateral Elbow Tendinopathy, Extensor Carpi Radialis Brevis (ECRB)
- Being tested
- wrist extensor strength training with BFR., wrist extensor strength training without BFR.
- Keywords
- Wrist extensor strength training, lateral epicondylitis, Tennis elbow, elbow pain
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wrist extensor strength training with BFR.Behavioural
Also called Wrist extensor strength training without BFR.
Wrist extensor strength training without BFR.
wrist extensor strength training without BFR.Behavioural
wrist extensor strength training without BFR.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: wrist extensor strength training with BFR. | Experimental | Experimental Group: Participants will undergo wrist extensor strength training with blood flow restriction (BFR). Receives: Behavioral: wrist extensor strength training with BFR. |
| Control Group: Wrist extensor strength training without BFR. | Active comparator | Control Group: Participants will undergo the same wrist extensor strength training without blood flow restriction (BFR). Receives: Behavioral: wrist extensor strength training without BFR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pressure pain thresholds (PPTs).
before and after intervention.
Measured: six weeks
pain-free grip strength test
before and after intervention.
Measured: six weeks
Secondary outcomes (1)
Borg 6-20 scale
Participants will be asked to rate their effort after each set of exercises on a scale from 6 (no exertion) to 20 (maximal exertion).
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start15 Feb 2025
- Primary completion15 May 2025
- Study completion25 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Epicondylitis (Tennis Elbow)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- This study will be a randomized controlled trial aimed at evaluating the effectiveness of wrist extensor strength training with blood flow restriction (BFR) in reducing pain, improving grip strength, and enhancing functional performance in individuals with lateral elbow tendinopathy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Majmaah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahnaz Hasan, PhD, Majmaah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007455
- Sponsor's protocol ID
- MUR
- Acronym
- BFR
- Status last verified
- Jan 2025
- First submitted
- 28 May 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Wrist Extensor Strength Training With Blood Flow Restriction on Lateral Elbow Tendinopathy
- ClinicalTrials.gov ID
- NCT07007455
- Acronym / sponsor ID
- BFR / MUR
- Conditions
- Lateral Epicondylitis (Tennis Elbow), Elbow Pain, Lateral Elbow Tendinopathy, Extensor Carpi Radialis Brevis (ECRB)
- Keywords
- Wrist extensor strength training, lateral epicondylitis, Tennis elbow, elbow pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Majmaah UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 25 May 2025 (actual)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will be a randomized controlled trial aimed at evaluating the effectiveness of wrist extensor strength training with blood flow restriction (BFR) in reducing pain, improving grip strength, and enhancing functional performance in individuals with lateral elbow tendinopathy.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: wrist extensor strength training with BFR. | Experimental | Behavioral: wrist extensor strength training with BFR.Experimental Group: Participants will undergo wrist extensor strength training with blood flow restriction (BFR). |
| Control Group: Wrist extensor strength training without BFR. | Active comparator | Behavioral: wrist extensor strength training without BFR.Control Group: Participants will undergo the same wrist extensor strength training without blood flow restriction (BFR). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Both Male and female, aged between 18 to 45 years old.
- Subjects with a positive test of lateral epicondylitis, which will be determined based on physical therapy assessment procedures.
- The presence of tenderness over the lateral epicondyle.positive Cozen's and Mill's tests.
- Pain on grasping.
- Pain on passive flexion of the wrist with elbow extension.
Key exclusion criteria (5 listed)
- Patients with shoulder tendinopathy, cervical radiculopathy, and rheumatoid arthritis.
- Presences of sensory and motor impairment of the upper extremities
- History of cardiovascular disease
- History of trauma and surgery on the elbow
- Having a history of malignancy and peripheral vascular disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wrist extensor strength training with BFR.Also: Wrist extensor strength training without BFR.Wrist extensor strength training without BFR. | Behavioural | Experimental Group: wrist extensor strength training with BFR. |
| wrist extensor strength training without BFR.wrist extensor strength training without BFR. | Behavioural | Control Group: Wrist extensor strength training without BFR. |
Primary outcome
pressure pain thresholds (PPTs).
Time frame: six weeks
before and after intervention.
pain-free grip strength test
Time frame: six weeks
before and after intervention.
1 secondary outcome
Borg 6-20 scale
Time frame: six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Undecided. Not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wrist extensor strength training with BFR. and wrist extensor strength training without BFR. in people with Lateral Epicondylitis (Tennis Elbow) and Elbow Pain, run by Majmaah University at 2 sites in Saudi Arabia.
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 7 inclusion and 5 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 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. 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?
pressure pain thresholds (PPTs). (time frame: six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2025.