Blood Flow Restriction + Physical Therapy for Tennis Elbow

Overseen By Chanda Mullen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Akron General Medical Center

Disqualifiers: Elbow sprain, Osteoarthritis, Vascular disorders, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores better ways to treat tennis elbow, a common condition causing pain on the outside of the elbow. Researchers compare two treatment methods: standard physical or occupational therapy and the same therapy combined with blood flow restriction, which uses a tourniquet to improve muscle recovery. Individuals with persistent elbow pain for at least four weeks and who experience tenderness or pain during specific movements might be suitable for this trial. The goal is to determine if adding blood flow restriction to therapy provides better pain relief and healing than therapy alone. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future treatment options for tennis elbow.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the blood flow restriction tourniquet is safe for treating tennis elbow?

Research has shown that blood flow restriction (BFR) treatment is generally well-tolerated. Studies have found that using a tourniquet to limit blood flow during therapy does not significantly increase pain. For instance, one study discovered that a single session of wrist exercises with BFR did not cause more pain than regular exercises, suggesting the treatment is safe for short-term use.

Another study examined BFR's effects on tennis elbow treatment and found little evidence of serious side effects. While research is ongoing, BFR appears to be a safe option for managing tennis elbow symptoms.

In summary, current research suggests that blood flow restriction is a safe addition to physical therapy for tennis elbow. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using blood flow restriction (BFR) with physical therapy for tennis elbow because it offers a new approach to rehabilitation. Traditional treatments like rest, anti-inflammatory medications, and standard physical therapy focus on reducing inflammation and pain. However, BFR therapy works differently by applying a tourniquet to limit blood flow during exercises, which may enhance muscle strength and recovery with less stress on the injured area. This method could potentially speed up recovery and improve outcomes compared to conventional therapies.

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

Research shows that using blood flow restriction (BFR) with physical therapy might help improve tennis elbow symptoms. In this trial, one group will receive physical and occupational therapy, including a blood flow restriction tourniquet. Studies have found that this method can help manage pain and increase grip strength. However, some evidence shows mixed results, and there isn't much data specifically supporting BFR for tennis elbow. Another group in this trial will receive standard evidence-based physical and occupational therapy without BFR. Early findings suggest that while BFR might be helpful, its superiority over standard therapy remains uncertain. More research is needed to confirm these results and understand how well BFR works for this condition. ^{1 3 4 6 7}

Who Is on the Research Team?

Aaron Lear, MD, CAQ

Principal Investigator

Cleveland Clinic Akron General

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-70 with tennis elbow experiencing pain for at least 4 weeks. It's not suitable for pregnant women, those unable to consent, recent surgery on the arms, active infections, cancer treatments, certain blood and vascular disorders, or if they've had injections in the affected area within the last 3 months.

Inclusion Criteria

My elbow pain will be diagnosed at my first therapy visit.

I have been diagnosed with tennis elbow or similar elbow pain.

I have been experiencing pain for over 4 weeks.

Exclusion Criteria

I have sickle cell anemia or the trait.

I have a broken bone in my arm.

I am currently diagnosed with cancer and receiving treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either evidence-based physical/occupational therapy or therapy with blood flow restriction over 6 visits

12 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary and secondary outcomes collected

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Blood flow restriction tourniquet
• Evidence based physical/occupational therapy

Trial Overview The study compares standard physical therapy against a combination of physical therapy with a blood flow restriction tourniquet to treat tennis elbow. Participants are randomly assigned to one of these two approaches in an open label setting.

How Is the Trial Designed?

Group I: Blood flow restriction with physical/occupational therapy Experimental Treatment 1 Intervention

physical/occupational therapy including use of blood flow restriction tourniquet over 6 visits (within a twelve week period).

Group II: Evidence based physical/occupational therapy Active Control 1 Intervention

evidence based physical/occupational therapy program over 6 visits (within a twelve week period) without use of blood flow restriction tourniquet

Who Is Running the Clinical Trial?

Akron General Medical Center

Lead Sponsor

Trials

7

Recruited

280+

Cleveland Clinic Akron General

Lead Sponsor

Trials

8

Recruited

480+

Published Research Related to This Trial

Blood flow restriction therapy (BFRT) uses a pneumatic cuff to restrict blood flow, creating a hypoxic environment that promotes muscle growth and strength gains, making it particularly beneficial for postoperative rehabilitation.

BFRT allows for effective low-load resistance training that achieves similar strength and hypertrophy results as higher-load training, but with less muscle swelling and pain, making it a safer option for those recovering from surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Therapy: An Evidence-Based Approach to Postoperative Rehabilitation. Watson, R., Sullivan, B., Stone, A., et al.[2023]

Blood flow restriction training (BFRT) combines low load resistance training with partial arterial and complete venous occlusion to promote muscle growth and strength, making it ideal for individuals recovering from injuries or surgeries.

The article discusses an ongoing randomized controlled trial investigating the effectiveness of BFRT specifically for treating lateral elbow tendinopathy, highlighting its potential therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Blood flow restriction training as a treatment option for lateral elbow tendinopathy-a study presentation]. Hinz, M., Franz, A., Pirker, C., et al.[2023]

In a randomized controlled trial involving 46 patients with lateral elbow tendinopathy, low-load resistance training with blood flow restriction (LLRT-BFR) significantly reduced pain intensity and improved grip strength compared to sham-BFR after 6 and 12 weeks.

Patients undergoing LLRT-BFR had higher odds of reporting complete recovery or significant improvement, indicating that this method may enhance recovery outcomes for those with lateral elbow tendinopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Load Resistance Training With Blood Flow Restriction Is Effective for Managing Lateral Elbow Tendinopathy: A Randomized, Sham-Controlled Trial. Karanasios, S., Korakakis, V., Moutzouri, M., et al.[2023]

Tennis elbow, primarily caused by tendon injuries at the lateral epicondyle, is a common condition affecting about 50% of tennis players, with significant impact on daily activities for one-third of them.

Treatment should start conservatively with methods like cryotherapy, nonsteroidal anti-inflammatory drugs, and rest, as tennis elbow is largely self-limiting; invasive therapies should only be considered when benefits clearly outweigh risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A rational management of tennis elbow. Kamien, M.[2018]

Blood flow restriction training (BFRT) shows promising preliminary evidence for improving tendon health and clinical outcomes, based on a review of 13 studies involving various tendon conditions.

However, due to the limited number of studies and the variability in intervention parameters, more research is needed to establish definitive conclusions and recommendations for BFRT in tendon rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Resistance Training in Tendon Rehabilitation: A Scoping Review on Intervention Parameters, Physiological Effects, and Outcomes. Burton, I., McCormack, A.[2022]

In a study of 46 subjects over 8 weeks, both blood flow restriction (BFR) training and traditional exercise led to significant strength gains in the rotator cuff muscles, but there was no difference in strength improvements between the two methods.

Both groups also experienced increases in supraspinatus tendon thickness, indicating that low-load, high-repetition exercises can effectively enhance rotator cuff strength and tendon size, regardless of BFR application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training for the Rotator Cuff: A Randomized Controlled Trial. Brumitt, J., Hutchison, MK., Kang, D., et al.[2023]

A survey of 250 orthopedic surgeons revealed that 59.8% currently use blood flow restriction (BFR) therapy, primarily for rehabilitation after anterior cruciate ligament reconstruction (ACLR), indicating its growing acceptance in clinical practice.

BFR therapy is typically applied 2-3 times per week, allowing patients to achieve benefits similar to high-intensity training while using lighter weights, which can be particularly useful for those recovering from musculoskeletal injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of blood flow restriction therapy for rehabilitation in Sports Medicine patients. Castle, JP., Tramer, JS., Turner, EHG., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03978897

Trial of Blood Flow Restriction Plus Physical Therapy vs. ... A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow. · Other Names: Delfi personalized tourniquet system.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36099170/

Low-Load Resistance Training With Blood Flow Restriction ... The primary outcome measures were pain intensity, patient-rated tennis elbow evaluation (PRTEE) score, pain-free grip strength, and global ...

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

An open label randomized controlled trial comparing ... Blood flow restriction treatment for lateral epicondylitis has little empirical evidence to support its use.

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

The immediate effects of wrist extensor training with blood ... The present study demonstrated that a single session of wrist extensor training with BFR does not produce a significant reduction in pain ...

6. tandfonline.com tandfonline.com/doi/full/10.1080/09593985.2025.2562909?src=

An open label randomized controlled trial comparing ... Blood flow restriction treatment for lateral epicondylitis has little empirical evidence to support its use. Objectives. To identify whether a blood flow ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04607356?tab=table

Blood Flow Restriction Exercise in the Treatment of Lateral ... This study will compare clinical effectiveness of two treatment programs in individuals with lateral elbow pain. Design: Prospective randomized controlled ...