Blood Flow Restriction Exercise for Tennis Elbow

(BFR Trial)

Overseen By Michael Rosenthal, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: United States Naval Medical Center, San Diego

Must not be taking: Anti-coagulants

Disqualifiers: Vascular disorders, Cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Up to 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for tennis elbow by comparing two methods. One group will follow a standard rehab program, while the other will do the same program with added blood flow restriction, a technique that limits blood flow to enhance exercise effects. The trial seeks participants who have experienced elbow pain for at least four weeks. The study aims to determine if adding blood flow restriction improves recovery more effectively than traditional methods alone. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance recovery methods for tennis elbow.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking anti-coagulant medications, you cannot participate in the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that blood flow restriction (BFR) training is still under investigation to confirm its safety. While some physical therapists use it, solid evidence for its effectiveness in treating tennis elbow remains limited. Studies on healthy individuals have produced mixed results regarding its effects on tendons. This indicates that much remains to be learned about BFR's efficacy and safety for tennis elbow treatment.

For those considering participation in a BFR treatment trial, it's important to know that although not fully proven, BFR is used in other areas of physical therapy. When performed correctly, it is generally considered safe, but further research is needed to understand its specific effects and safety for tennis elbow. Consulting healthcare professionals is essential to understand the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Blood Flow Restriction (BFR) in the treatment of lateral epicondylalgia, commonly known as tennis elbow, because it introduces a new way to enhance traditional rehabilitation techniques. Unlike typical treatments that focus solely on exercises and ergonomic adjustments, BFR involves restricting blood flow to the muscles during resistance exercises, which can stimulate muscle strength and growth even at low intensities. This unique approach may offer quicker recovery times and improved outcomes by maximizing the benefits of regular exercise routines, making it a promising addition to the standard care options.

What evidence suggests that this trial's treatments could be effective for tennis elbow?

Research has shown that blood flow restriction (BFR) training can help treat tennis elbow. In this trial, one group will receive evidence-informed care, including a standardized rehabilitation program. Another group will receive the same care with the addition of BFR during resistive exercises. One study found that adding BFR to regular physical therapy exercises improved results for people with this condition. Another report showed that wrist exercises with BFR were beneficial alongside traditional treatments. However, a single BFR session did not significantly reduce pain compared to exercises without it, according to one study. Overall, BFR training seems promising when combined with traditional therapy, offering better recovery for those with tennis elbow. ^{1 3 4 5 6}

Who Is on the Research Team?

Tara Haugen, MSOT

Principal Investigator

United States Naval Medical Center, San Diego

Are You a Good Fit for This Trial?

Inclusion Criteria

You have pain on the outer side of your elbow, which is sometimes called "tennis elbow" or wrist extensor tendinopathy.

Between the ages of 18-65

You have been experiencing elbow pain for at least 4 weeks.

Exclusion Criteria

Any history of ligamentous, bony or other soft tissue reconstruction surgery at the affected elbow.

You are pregnant.

Inability to consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a standardized rehabilitation program or a program with blood flow restriction exercises for lateral epicondylalgia

Up to 12 weeks

1-3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up at 3 weeks, 6 weeks, 3 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Blood Flow Restriction
• Evidence-informed care

How Is the Trial Designed?

Group I: Evidence-informed care + Blood Flow Restriction (BFR) Experimental Treatment 1 Intervention

Standardized, evidence based rehabilitation program for lateral epicondylalgia to include: discussion of ergonomics, home exercise program performance, use of any prescribed splint or brace, forearm and shoulder stretches, soft tissue mobilization, and performance of standard resistance exercises with the addition of BFR while performing resistive exercises.

Group II: Evidence-informed care Active Control 1 Intervention

Standardized, evidence based rehabilitation program for lateral epicondylalgia to include: discussion of ergonomics, home exercise program performance, use of any prescribed splint or brace, forearm and shoulder stretches, soft tissue mobilization, and performance of standard resistance exercises.

Who Is Running the Clinical Trial?

United States Naval Medical Center, San Diego

Lead Sponsor

Trials

110

Recruited

24,200+

Published Research Related to This Trial

Resistance training with blood flow restriction (BFR) at low loads can produce muscle fatigue comparable to high-load training, with 21 participants showing that 20% maximal voluntary contraction (MVC) with continuous partial occlusion caused greater fatigue than high-load training (31% vs 19% decrement in MVC).

The study suggests that specific BFR protocols, particularly the 20% MVC with continuous partial occlusion, may be more effective for muscle fatigue than other BFR methods or high-load training, indicating potential for optimizing resistance training strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise load and blood-flow restriction on skeletal muscle function. Cook, SB., Clark, BC., Ploutz-Snyder, LL.[2022]

In a study of 39 female patients with chronic ankle instability, Blood Flow Restriction (BFR) training alone did not improve muscle strength, dynamic balance, or physical function, while combined BFR with rehabilitation and rehabilitation alone showed significant improvements.

Both the BFR+R and R groups demonstrated enhanced muscle strength and dynamic balance, indicating that BFR is more effective when used alongside rehabilitation rather than as a standalone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of blood flow restriction as a stand-alone treatment on muscle strength, dynamic balance, and physical function in female patients with chronic ankle instability. Mahmoud, WS., Radwan, NL., Ibrahim, MM., et al.[2023]

Blood flow restriction (BFR) training is considered a safe and effective method for improving musculoskeletal training outcomes, supported by 25 years of research.

There is a need for standardized, evidence-based protocols for BFR training among health professionals in South Africa to ensure its proper and safe application during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow restriction training in South Africa - a panel discussion. Evans, RW., Ganda, J., van Schalkwyk, L., et al.[2023]

A survey of 108 participants using BFR/KAATSU devices revealed that 61.4% used inflatable devices, and most had received some form of education before using the equipment, indicating a commitment to safe application of the training method.

Adverse effects such as bruising, lightheadedness, and cramping were reported by 21.4% of users, highlighting the need for careful monitoring and screening before administering BFR/KAATSU training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Trends in Blood Flow Restriction. Cuffe, M., Novak, J., Saithna, A., et al.[2022]

In a study involving 75 participants, it was found that using 130% of resting brachial systolic blood pressure can effectively estimate the occlusion needed for blood flow restriction (BFR) training, achieving similar effects to 100% limb occlusion pressure (LOP).

Applying arbitrary restriction values of 200 and 300 mm Hg can exceed safe occlusion levels, potentially increasing risks during BFR exercise, while using 100 mm Hg or resting brachial systolic pressure is safer and results in pressures between 60% and 80% LOP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training in Clinical Rehabilitation: Occlusion Pressure Methods Relative to the Limb Occlusion Pressure. Chulvi-Medrano, I., Cortell-Tormo, JM., Hernández-Sánchez, S., et al.[2023]

A randomized controlled trial with 26 healthy participants showed that low-load blood flow restriction (BFR) training significantly increased muscle strength and limb circumference compared to a control group, with no reported adverse events.

BFR training was effective for strengthening muscle groups both proximal and distal to the tourniquet, and even improved strength in the non-restricted extremity, suggesting a systemic benefit from this training method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. Bowman, EN., Elshaar, R., Milligan, H., et al.[2020]

Blood flow restriction (BFR) training is effective for increasing muscle size and strength, making it a promising option for treating musculoskeletal issues and aiding in postoperative recovery.

The article highlights the need for more research on BFR's applications in rehabilitation, while also sharing the authors' practical experiences with its use after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Blood Flow Restriction Training for Postoperative Rehabilitation. Wilkinson, BG., Donnenwerth, JJ., Peterson, AR.[2019]

Blood flow restriction training (BFRT) is generally safe for patients with musculoskeletal disorders, with a systematic review of 19 studies involving 322 participants showing that most did not report adverse events.

While some rare adverse events were noted, such as deep vein thrombosis and rhabdomyolysis, individuals undergoing BFRT did not experience more adverse events compared to those doing regular exercise, indicating its potential as a safe strengthening method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. Minniti, MC., Statkevich, AP., Kelly, RL., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07172568

Blood Flow Restriction Training For The Treatment Of ... The study aims to evaluate the effectiveness of Blood Flow Restriction Training for the treatment of lateral elbow epicondylopathy. Detailed ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10043636/

Wrist Extensor Training With Blood Flow Restriction for the ... The aim of this case report is to evaluate the effect of wrist extensor exercises with blood flow restriction (BFR) as an add-on intervention to a multi-modal ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06490692

The Effect of Blood Flow Restriction Training on Tennis ... Given the commonality and impact of lateral epicondylitis symptoms, this study aims to compare the effectiveness between BFR training with standard PT exercises ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666337625000356

The immediate effects of wrist extensor training with blood ... A single session of wrist extensor training with BFR does not produce a significant reduction in pain sensitivity compared to the same training without BFR in ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/09593985.2025.2562909?src=exp-la

An open label randomized controlled trial comparing ... The aim of this study was to investigate the effectiveness of a real-world PT program with the inclusion of BFR training compared to a standard ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12096532/

The impact of blood flow restriction training on tendon ... In the nine studies on healthy individuals, the effects of BFRT showed contradictory results regarding tendon-related outcomes. However, changes ...