What side effects are associated with this type of intervention?

Common treatments for Tennis Elbow, such as glucocorticoid injections, physical therapy, and Blood Flow Restriction (BFR) Tourniquet, have various side effects. Glucocorticoid injections can provide short-term relief but may lead to high recurrence rates and worse long-term outcomes, including potential tendon weakening. Physical therapy is generally safe but may cause temporary discomfort or pain during exercises. BFR Tourniquet, which enhances muscle strength and recovery, can cause muscle soreness, bruising, and a risk of blood clots if not properly monitored. Patients should discuss these potential side effects with their healthcare provider to choose the most appropriate treatment.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of Tennis Elbow (lateral epicondylitis). Treatment typically involves physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and in some cases, platelet-rich plasma (PRP) injections. Blood Flow Restriction (BFR) therapy, which enhances muscle strength and recovery by creating a hypoxic environment, is an emerging treatment modality but has not yet received specific FDA approval for Tennis Elbow. BFR therapy is being studied for its potential benefits in muscle growth and repair, similar to the trial mentioned.

What other types of research exist?

Promising alternatives to Blood Flow Restriction Tourniquet for Tennis Elbow patients include: 1) Eccentric exercise programs, which have been shown to improve tendon health and reduce pain. 2) Shockwave therapy, which promotes tissue regeneration and pain relief. 3) Platelet-Rich Plasma (PRP) injections, which utilize growth factors to enhance healing. 4) Ultrasound-guided percutaneous tenotomy, a minimally invasive procedure to remove damaged tissue and stimulate repair.

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Behavioural Intervention

Blood Flow Restriction + Physical Therapy for Tennis Elbow

N/A

Waitlist Available

Led By Aaron Lear, MD, CAQ

Research Sponsored by Akron General Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All participants must be between the age of 18 and 70 years old and have had pain for 4 weeks or more.

Pain for 4 weeks or more.

Must not have

Sickle cell anemia or trait.

Current fracture in affected arm.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from the tourniquet, bruising or swelling at the application site. Since it involves restricting blood flow temporarily, there might be temporary numbness or tingling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old and have had pain for over 4 weeks.

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I have been experiencing pain for over 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have sickle cell anemia or the trait.

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I have a broken bone in my arm.

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I am currently diagnosed with cancer and receiving treatment.

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I do not have an active infection.

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I have had surgery to remove lymph nodes due to cancer.

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I do not have elbow sprain, elbow osteoarthritis, or nerve pain in my arm.

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I have not had injections for pain or inflammation in the affected area in the last 3 months.

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I have had surgery on my elbow for ligament, bone, or soft tissue repair.

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I have had surgery on my affected arm in the past year.

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I am unable to give consent for medical procedures.

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I have a history of blood clots or vascular disease.

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I am on kidney dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient rated tennis elbow evaluation (PRTEE)

Secondary study objectives

Maximum grip strength

Numeric pain rating scale

Other treatments received

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Blood flow restriction with physical/occupational therapyExperimental Treatment1 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 therapyActive Control1 Intervention

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

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Tennis Elbow include Blood Flow Restriction (BFR) therapy, eccentric exercises, and corticosteroid injections. BFR therapy enhances muscle strength and recovery by creating a hypoxic environment that stimulates muscle growth and repair, which is crucial for patients needing to rebuild muscle function and reduce pain. Eccentric exercises involve lengthening the muscle under tension, which helps in remodeling the tendon and reducing pain. Corticosteroid injections reduce inflammation and provide short-term pain relief, although they may not address the underlying tendon pathology. These treatments are important for Tennis Elbow patients as they target different aspects of the condition, from pain relief to muscle and tendon repair, ultimately improving function and quality of life.

Blood flow restriction exercise stimulates mobilization of hematopoietic stem/progenitor cells and increases the circulating ACE2 levels in healthy adults.Effects of blood-flow restriction on biomarkers of myogenesis in response to resistance exercise.Endothelial dysfunction and tendinopathy: how far have we come?