NCT03978897

Trial of Blood Flow Restriction Plus Physical Therapy vs. Physical Therapy Alone for Lateral Epicondylitis

A Randomized Controlled Trial of Blood Flow Restriction Plus Conventional Physical Therapy vs. Conventional Physical Therapy Alone in the Treatment of Lateral Epicondylitis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cleveland Clinic Akron General · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Open label randomized controlled trial comparing evidenced based physical/occupational therapy vs. physical/occupational therapy including blood flow restriction tourniquet in the treatment of lateral epicondylitis (tennis elbow).

Detailed description

Patients will be randomized to one of two groups, and treatment will be open label and unblinded. A target of 44 patients for enrollment has been set for 80% power. Treatment will last for 6 visits with physical therapy with recommended visit intervals of 1 week : Intervention Group: Evidence based physical/occupational therapy, with the addition of therapeutic exercises using a blood flow restriction tourniquet. Control Group: Patients will receive standard evidence based physical therapy The primary outcome (Patient-Rated Tennis Elbow Evaluation \[PRTEE\]) will be collected at enrollment, 3, 6, and 12 months. Secondary outcomes will be collected at the beginning and end of physical therapy interventions (change in: numeric pain rating scale, maximum pain free grip strength, pain free grip strength). We will collect treatments received after the end of physical therapy and before final follow up.

Conditions

• Lateral Epicondylitis

Interventions

Type	Name	Description
DEVICE	Blood flow restriction tourniquet	A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow.
OTHER	Evidence based physical/occupational therapy	Up to date physical/occupational therapy for lateral epicondylitis

Timeline

• Start date: 2019-07-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2019-06-07
• Last updated: 2024-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study