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Clinical Trials/NCT05237869
NCT05237869
Recruiting
Not Applicable

Blood Flow Restricted Training to Enhance Lateral Epicondylitis Rehabilitation.

Julie Nuelle1 site in 1 country250 target enrollmentMay 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lateral Epicondylitis
Sponsor
Julie Nuelle
Enrollment
250
Locations
1
Primary Endpoint
Define the effect of BFR training on pain with activity in patients with LE.
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 20, 2022
End Date
April 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Julie Nuelle
Responsible Party
Sponsor Investigator
Principal Investigator

Julie Nuelle

Assistant Professor of Orthopaedic Surgery, Hand Surgeon

University of Missouri-Columbia

Eligibility Criteria

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
  • 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
  • Uncontrolled peripheral vascular disease

Outcomes

Primary Outcomes

Define the effect of BFR training on pain with activity in patients with LE.

Time Frame: 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.

Study Sites (1)

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