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

NCT03978897 | Completed Results FDA Device

• 1 other identifier: 19001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Lateral Epicondylitis

Keywords

lateral epicondylitis; tennis elbow; blood flow restriction; physical therapy

Outcome Measures

Primary Outcomes (1)

• Change in Patient Rated Tennis Elbow Evaluation (PRTEE)

  Change in score on 'Patient rated tennis elbow evaluation' total score from baseline to 12 month final follow up. 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 Outcomes (4)

• Numeric Pain Rating Scale

  12 months

• Pain Free Grip Strength

  at final therapy visit up to 12 weeks after enrollment

• Maximum Grip Strength

  at final therapy visit up to 12 weeks after enrollment

• Other Treatments Received

  12 months

Study Arms (2)

Blood flow restriction with physical/occupational therapy

EXPERIMENTAL

physical/occupational therapy including use of blood flow restriction tourniquet over 6 visits (within a twelve week period).

Device: Blood flow restriction tourniquet

Evidence based physical/occupational therapy

ACTIVE COMPARATOR

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

Interventions

Blood flow restriction tourniquet DEVICE

A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow.

Also known as: Delfi personalized tourniquet system

Blood flow restriction with physical/occupational therapy

Evidence based physical/occupational therapy OTHER

Up to date physical/occupational therapy for lateral epicondylitis

Evidence based physical/occupational therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cleveland Clinic Akron General: lead

Study Sites (1)

Cleveland Clinic Akron General

Akron, Ohio, 44307, United States

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Results Point of Contact

• Title: Aaron Lear
• Organization: Cleveland Clinic

leara@ccf.org

330.344.6047

Study Officials

• Aaron Lear, MD, CAQ

  Cleveland Clinic Akron General

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Treating therapists and patient will be aware of treatment. The outcome assessor will have access to outcome data only, without knowledge of which treatment patient received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Primary Care Sports Medicine

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: June 7, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 5, 2026
• Results First Posted: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)