Blood Flow Restriction & Tennis Elbow Rehab

NCT05237869 | Recruiting FDA Device

• 1 other identifier: 2070985
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Lateral Epicondylitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Physical Therapy

SHAM COMPARATOR

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

Blood Flow Restricted Physical Therapy

ACTIVE COMPARATOR

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

Device: Blood Flow Restriction Device

Interventions

Blood Flow Restriction Device 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.

Blood Flow Restricted Physical Therapy

Standard Physical Therapy OTHER

Standard physical therapy protocol for lateral epicondylitis rehab without blood flow restriction.

Physical Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Julie Nuelle: lead

Study Sites (1)

Vicki Jones

Columbia, Missouri, 65212, United States

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• Julia Nuelle, MD

  University of Missouri Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vicki Jones, MEd, CCRP

CONTACT

5738827583; jonesvicki@health.missouri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery, Hand Surgeon

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: February 14, 2022
• Study Start: May 20, 2022
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)