Lateral Epicondylitis
Conditions
Brief summary
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.
Interventions
DEVICEBlood Flow Restriction Device
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.
OTHERStandard Physical Therapy
Standard physical therapy protocol for lateral epicondylitis rehab without blood flow restriction.
Sponsors
Julie Nuelle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Ages 18-65 years of age 2. Diagnosis of lateral epicondylitis confirmed by the treating orthopaedic surgeon and ultrasound 3. Must be able to read and write in English 4. Able to provide own written consent
Exclusion criteria
1. Patients over 65 years of age 2. Contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength or daily pain greater than 1/10 3. History of prior injection for treatment of lateral epicondylitis 4. Pregnancy 5. Recent history of deep venous thrombosis (within the past 12 months) 6. Active treatment with anticoagulants 7. History of upper quadrant lymph node dissection 8. History of endothelial dysfunction 9. Patient history of easy bruising 10. Active infection in the injured arm 11. Cancer 12. Uncontrolled peripheral vascular disease 13. Uncontrolled diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Define the effect of BFR training on pain with activity in patients with LE. | 3 weeks to 6 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJulia Nuelle, MD
University of Missouri Department of Orthopaedic Surgery
Outcome results
None listed