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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Lateral Epicondylitis
• Intervention / Treatment: Device: Blood flow restriction tourniquet; Other: Evidence based physical/occupational therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Akron, Ohio, United States, 44307
      • Cleveland Clinic Akron General

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The diagnoses included are lateral elbow pain, lateral epicondylitis, or lateral epicondylalgia, more general diagnoses elbow tendinitis or elbow pain will be included if their clinical picture at physical therapy meets criteria for lateral epicondylitis.
• If the inclusion diagnosis is other than lateral epicondylitis or tennis elbow (such as elbow pain), we will confirm the diagnosis at the first therapy visit with tenderness at the lateral epicondyle and/or pain with resisted wrist/long finger extension at the lateral epicondyle.
• Pain for 4 weeks or more.
• All participants must be between the age of 18 and 70 years old and have had pain for 4 weeks or more.

Exclusion Criteria:

• Ligamentous elbow sprain, osteoarthritis of elbow and cervical radiculopathy in the affected limb will be excluded from the study.
• Any history of ligamentous, bony or other soft tissue reconstruction surgery at the affected elbow,
• Vascular disorders to include: history of DVT, history of endothelial dysfunction, peripheral vascular disease
• Injection therapy (corticosteroid, platelet rich plasma, or other injection therapy) in the prior 3 months to the affected site
• Current fracture in affected arm
• History of crush injury to affected arm
• Any surgery on affected arm in last 1 year
• Surgical procedure on their contralateral extremity (Changed 9/2019 to surgery within last year on contralateral upper extremity).
• History of lymphectomy (such as axillary exploration with breast surgery, lymph node biopsy in the affected axilla/arm)
• Pregnancy
• Active infection
• Current cancer diagnosis/treatment
• Sickle cell anemia or trait
• Kidney dialysis
• History of syncope/passing out with pressure to body (such as massage, or blood pressure cuff).
• inability to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood flow restriction with physical/occupational therapy; physical/occupational therapy including use of blood flow restriction tourniquet over 6 visits (within a twelve week period).	Device: Blood flow restriction tourniquet; A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow.; Other Names: Delfi personalized tourniquet system
Active Comparator: Evidence based physical/occupational therapy; evidence based physical/occupational therapy program over 6 visits (within a twelve week period) without use of blood flow restriction tourniquet	Other: Evidence based physical/occupational therapy; Up to date physical/occupational therapy for lateral epicondylitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient rated tennis elbow evaluation (PRTEE)	Change in score on 'Patient rated tennis elbow evaluation' total score. Lower numbers suggest less pain, higher scores suggest more pain. Total score 0-100. Includes pain subscale (0-50) Specific activities subscale (0-60) Usual activities subscale (0-40) Function Subscale= (specific activities score + usual activities score)/2 (0-50) Total Score= Pain subscale + Function Subscale (0-100)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric pain rating scale	change in score on 0-10 pain rating scale with 0 being no pain, and 10 being worst pain.	12 months
Pain free grip strength	Change in pain free grip strength on dynamometer	at final therapy visit up to 12 weeks after enrollment
Maximum grip strength	Change in maximum grip strength on dynamometer	at final therapy visit up to 12 weeks after enrollment
Other treatments received	We will collect data on whether the patient sought or received treatments beyond physical/occupational therapy over the 12 months of enrollment in the study	12 months

Collaborators and Investigators

• Sponsor: Cleveland Clinic Akron General
• Investigators: Principal Investigator: Aaron Lear, MD, CAQ, Cleveland Clinic Akron General

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: physical therapy; tennis elbow; lateral epicondylitis; blood flow restriction
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Elbow Injuries; Tennis Elbow
• Other Study ID Numbers: 19001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes