Blood Flow Restriction & Tennis Elbow Rehab

NCT ID: NCT05237869

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2026-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Standard Physical Therapy

Intervention Type: OTHER

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

Blood Flow Restricted Physical Therapy

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

Group Type: ACTIVE_COMPARATOR

Blood Flow Restriction Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Standard Physical Therapy

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Julie Nuelle

OTHER

Sponsor Role: lead

Responsible Party

Julie Nuelle

Assistant Professor of Orthopaedic Surgery, Hand Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Julia Nuelle, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri Department of Orthopaedic Surgery

Locations

Vicki Jones

Columbia, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vicki Jones, MEd, CCRP

Role: CONTACT

jonesvicki@health.missouri.edu

5738827583

Facility Contacts

Vicki Jones, MEd, CCRP

Role: primary

jonesvicki@health.missouri.edu

573-882-7583

Other Identifiers

2070985

Identifier Type: -

Identifier Source: org_study_id