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

Trial Summary

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 data supports the effectiveness of the treatment Blood Flow Restriction Therapy for Tennis Elbow?

Research shows that low-load resistance training with blood flow restriction (BFR) significantly reduces pain and improves grip strength in patients with tennis elbow compared to a similar treatment without BFR. This suggests that BFR can be an effective part of rehabilitation for this condition. ^{1 2 3 4 5}

Is Blood Flow Restriction Therapy safe for humans?

Blood Flow Restriction Therapy has been used safely in various rehabilitation settings, showing benefits like improved strength and reduced pain, but there is no standardized application, and safety data specific to tennis elbow is limited. ^{1 4 5 6 7}

How does blood flow restriction therapy differ from other treatments for tennis elbow?

Blood flow restriction therapy is unique because it involves exercising with restricted blood flow, which helps build muscle strength and reduce pain without needing heavy weights. This makes it particularly useful for people recovering from injuries like tennis elbow, where traditional high-load exercises might not be feasible. ^{1 4 6 7 8}

What is the purpose of this trial?

Lateral epicondylitis (LE), often referred to as "tennis elbow" is a common and debilitating overuse injury affecting 1-3% of adults annually. LE is most often defined as a syndrome of pain near the area of the lateral epicondyle of the elbow commonly effecting the origin of the extensor carpi radialis brevis with associated weakness; it most commonly effects the dominant arm. The best treatment for LE is unknown and research to support current treatment methods are insufficient. A common limitation in functional recovery experienced by this population is pain at the lateral aspect of the elbow. As such, innovative therapeutic interventions directed at quickly reducing pain may address this unmet need and allow for improved outcomes, as well as earlier return to function.

Research Team

Julia Nuelle, MD

Principal Investigator

University of Missouri Department of Orthopaedic Surgery

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. 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]

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

A rational management of tennis elbow. [2018]

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

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

4. 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]

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

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

6. Germany pubmed.ncbi.nlm.nih.gov

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

7. India pubmed.ncbi.nlm.nih.gov

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

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

Local and Systemic Effects of Blood Flow Restriction Therapy in an Animal Model. [2020]