Blood Flow Restriction & Tennis Elbow Rehab

Blood Flow Restricted Training to Enhance Lateral Epicondylitis Rehabilitation.

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.

Study Overview

• Status: Suspended
• Conditions: Lateral Epicondylitis
• Intervention / Treatment: Other: Standard Physical Therapy; Device: Blood Flow Restriction Device

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Vicki Jones

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Physical Therapy; 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; Standard physical therapy protocol for lateral epicondylitis rehab without blood flow restriction.
Active Comparator: Blood Flow Restricted Physical Therapy; Physical therapy assisted by blood flow restriction per standard physical therapy protocol.	Device: Blood 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Julie Nuelle
• Investigators: Principal Investigator: Julia Nuelle, MD, University of Missouri Department of Orthopaedic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Elbow Tendinopathy; Elbow Injuries; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Arm Injuries; Tendinopathy; Tennis Elbow
• Other Study ID Numbers: 2070985

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes