Blood Flow Restriction & Tennis Elbow Rehab

Study Overview
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Brief Summary
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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.

Official Title
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Blood Flow Restricted Training to Enhance Lateral Epicondylitis Rehabilitation.

Conditions
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Lateral Epicondylitis

Intervention / Treatment
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* Device: Blood Flow Restriction Device
* Other: Standard Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-65 years of age Diagnosis of lateral epicondylitis confirmed by the treating orthopaedic surgeon and ultrasound Must be able to read and write in English Able to provide own written consent Exclusion Criteria: Patients over 65 years of age Contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength or daily pain greater than 1/10 History of prior injection for treatment of lateral epicondylitis Pregnancy Recent history of deep venous thrombosis (within the past 12 months) Active treatment with anticoagulants History of upper quadrant lymph node dissection History of endothelial dysfunction Patient history of easy bruising Active infection in the injured arm Cancer Uncontrolled peripheral vascular disease Uncontrolled diabetes mellitus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Physical Therapy<br>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. | Other: Standard Physical Therapy<br>* Standard physical therapy protocol for lateral epicondylitis rehab without blood flow restriction.<br>|
| Active Comparator: Blood Flow Restricted Physical Therapy<br>Physical therapy assisted by blood flow restriction per standard physical therapy protocol. | Device: Blood Flow Restriction Device<br>* Occlusion training involves the application of a cuff to the upper arm that is designed to restrict only the low-pressure blood flow in veins. It does not prevent blood flowing from the heart to the arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Define the effect of BFR training on pain with activity in patients with LE. | Measured on a 0-10 scale by VAS (Visual Analog Scale) patient reported outcome form. The VAS is scored 0-10, and a higher score indicates worse pain/worse outcomes. | 3 weeks to 6 months |