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Blood Flow Restriction & Tennis Elbow Rehab

NCT05237869 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-04-25

No results posted yet for this study

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

Interventions

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.

OTHER

Standard Physical Therapy

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

Sponsors & Collaborators

  • Julie Nuelle

    lead OTHER

Principal Investigators

  • Julia Nuelle, MD · University of Missouri Department of Orthopaedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2026-04-01
Completion
2026-04-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05237869 on ClinicalTrials.gov