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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Blood flow restriction tourniquet and Evidence based physical/occupational therapy for tennis elbow?

Research shows that using blood flow restriction with low-load resistance training can significantly reduce pain and improve grip strength in people with tennis elbow compared to similar exercises without blood flow restriction. This suggests that the treatment may help improve recovery and function in those with tennis elbow. ^{1 2 3 4 5}

Is blood flow restriction therapy safe for humans?

Blood flow restriction therapy, which involves using a tourniquet to limit blood flow during exercise, has been used safely in various rehabilitation settings. Studies have shown it does not cause harmful systemic cellular responses, making it generally safe for humans. ^{1 4 5 6 7}

How does the treatment of blood flow restriction with physical therapy for tennis elbow differ from other treatments?

This treatment is unique because it combines blood flow restriction (BFR) with low-load resistance training, which restricts blood flow to create a hypoxic (low oxygen) environment, promoting muscle strength and recovery without the need for heavy weights. This approach is particularly beneficial for those who cannot tolerate high training loads, offering a novel way to improve recovery in tennis elbow compared to traditional therapies. ^{1 4 7 8 9}

What is the purpose of this trial?

This trial compares standard physical therapy to physical therapy with a special band that slightly restricts blood flow. It targets patients with tennis elbow to see if this method improves their condition more effectively. The band is thought to enhance muscle strength and healing by limiting blood flow during exercises. Evidence supports the use of resistance training at a reduced load in combination with blood flow restriction to improve muscle strength and healing.

Research Team

Aaron Lear, MD, CAQ

Principal Investigator

Cleveland Clinic Akron General

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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) 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Blood flow restriction training as a treatment option for lateral elbow tendinopathy-a study presentation]. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Conservative Treatment of Tennis Elbow. [2016]

3. New Zealand pubmed.ncbi.nlm.nih.gov

A rational management of tennis elbow. [2018]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Using a Pneumatic Tourniquet Is Not Associated With a Cellular Systemic Response. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Survey of blood flow restriction therapy for rehabilitation in Sports Medicine patients. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Therapy: An Evidence-Based Approach to Postoperative Rehabilitation. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training for the Rotator Cuff: A Randomized Controlled Trial. [2023]