Blood Flow Restriction & Tennis Elbow Rehab

Lateral Epicondylitis Clinical Trial

Official title:

Blood Flow Restricted Training to Enhance Lateral Epicondylitis Rehabilitation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05237869
• Other study ID #: 2070985
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2022
• Est. completion date: April 1, 2025

Study information

• Verified date: April 2024
• Source: University of Missouri-Columbia
• Contact: Vicki Jones, MEd, CCRP
• Phone: 5738827583
• Email: jonesvicki[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

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.

Locations

Country	Name	City	State
United States	Vicki Jones	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Julie Nuelle

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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