Blood Flow Restriction Therapy for Tennis Elbow

Recruiting at 1 trial location

Overseen By Vicki Jones, MEd, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Julie Nuelle

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Cancer, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with tennis elbow, a painful condition affecting the elbow common in adults. It compares regular physical therapy to a version using blood flow restriction, a technique involving a blood flow restriction device, which might reduce pain faster and help people return to normal activities sooner. Individuals diagnosed with tennis elbow by a doctor and experiencing elbow pain might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance recovery and quality of life.

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 actively being treated with anticoagulants (blood thinners), you cannot participate.

What prior data suggests that this blood flow restriction device is safe for treating tennis elbow?

Research has shown that blood flow restriction (BFR) therapy is generally safe and well-tolerated for individuals with joint and muscle problems. Some studies suggest that BFR therapy can help reduce pain and improve movement in conditions like tennis elbow. Although specific side effects for tennis elbow aren't widely reported, trained professionals usually perform BFR therapy safely.

Other studies report that people using BFR therapy sometimes experience mild discomfort, but serious issues are rare. The therapy has been successfully used in other rehabilitation cases, indicating its general safety. However, specific data on its use for tennis elbow remains limited, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about blood flow restriction therapy for tennis elbow because it offers a unique approach compared to traditional physical therapy. Unlike standard treatments, which typically involve exercises to strengthen the arm muscles and reduce pain, this method incorporates a specialized cuff that gently restricts blood flow during therapy sessions. This restriction is thought to enhance muscle strength and recovery by creating a low-oxygen environment that stimulates muscle growth and repair. By potentially accelerating recovery and improving outcomes, this innovative technique could provide a more effective solution for those suffering from tennis elbow.

What evidence suggests that blood flow restriction therapy is effective for tennis elbow?

Research has shown that blood flow restriction (BFR) therapy can aid people with tennis elbow. In this trial, some participants will receive BFR therapy, which uses a cuff to gently limit blood flow during exercise, potentially strengthening muscles and speeding recovery. In some studies, patients who tried BFR therapy reported less pain and better grip strength than those who underwent regular physical therapy. Other participants in this trial will receive standard physical therapy with a sham comparator. Many patients have noticed reduced pain and improved elbow function with BFR therapy. These findings suggest BFR therapy could be a promising treatment for tennis elbow, helping patients return to normal activities sooner. ^{1 4 5 6 7}

Who Is on the Research Team?

Julia Nuelle, MD

Principal Investigator

University of Missouri Department of Orthopaedic Surgery

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with tennis elbow confirmed by a surgeon and ultrasound. Participants must read/write English and consent themselves. Excluded are those with vascular diseases, bruising issues, infections, cancer, diabetes, prior injections for the condition, recent deep vein thrombosis, other arm disabilities, anticoagulant use or pregnancy.

Inclusion Criteria

Must be able to read and write in English

Able to provide own written consent

My elbow pain has been confirmed as tennis elbow by a surgeon and ultrasound.

Exclusion Criteria

I bruise easily.

I have had surgery to remove lymph nodes in the upper part of my body.

I have had a deep vein clot in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo physical therapy with or without blood flow restriction

3 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Blood Flow Restriction Device
• Standard Physical Therapy

Trial Overview

The study tests a Blood Flow Restriction Device against Standard Physical Therapy to treat tennis elbow. It aims to see if reducing blood flow can quickly lessen pain and improve recovery compared to usual therapy methods.

How Is the Trial Designed?

Group I: Blood Flow Restricted Physical Therapy Active Control 1 Intervention

Physical therapy assisted by blood flow restriction per standard physical therapy protocol.

Group II: Physical Therapy Placebo Group 1 Intervention

For patients enrolled in the control group, the participants will undergo calibration of the Delfi Personalized Tourniquet System to measure limb occlusion pressure and will wear the cuff during completion of the exercises with minimal inflation (approximately 5%), to hold the cuff in place during treatment. This will act as a sham.

Who Is Running the Clinical Trial?

Julie Nuelle

Lead Sponsor

Trials

2

Recruited

430+

Published Research Related to This Trial

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]

Blood flow restriction training, which involves low-intensity exercise while wearing a blood pressure cuff, is proposed to enhance strength gains and improve performance, despite skepticism from physical therapists about its effectiveness.

This training method may also lead to shorter recovery times and reduced pain after exercise, suggesting potential benefits for rehabilitation and performance enhancement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training in Rehabilitation: A Useful Adjunct or Lucy's Latest Trick? Whiteley, R.[2020]

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]

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]

This paper provides physical therapists with essential guidelines for diagnosing the causes of pain associated with tennis elbow, which is crucial for effective treatment.

It outlines a comprehensive rehabilitation and preventive program designed to help patients recover and return to their desired level of athletic activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Tennis elbow"; evaluation, treatment, and prevention. LaFreniere, JG.[2022]

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]

In a controlled study involving 40 rats, ischemic therapies like blood flow restriction therapy (BFRT) and repetitive restriction of muscle blood flow (RRMBF) did not lead to improvements in muscle mass, strength, or satellite cell density, suggesting limited efficacy for these methods in enhancing muscle function.

However, the RRMBF group showed significantly elevated growth hormone (GH) levels, indicating a potential biochemical response to this type of ischemic therapy, even though it did not translate to physical improvements in muscle characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local and Systemic Effects of Blood Flow Restriction Therapy in an Animal Model. Ramme, AJ., Darcy, R., Rourke, BJ., et al.[2020]

Citations

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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 ...

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The primary outcome measures were pain intensity, patient-rated tennis elbow evaluation (PRTEE) score, pain-free grip strength, and global ...

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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 ...

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Blood Flow Restriction Training For The Treatment Of ...

The first positive results of BFR training compared to conventional physiotherapy have already been shown in rehabilitation after replacement ...

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The impact of blood flow restriction training on tendon ...

Blood flow restriction training (BFRT) has shown promising results in the rehabilitation of painful musculoskeletal ailments such as knee ...