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

NCT ID: NCT03978897

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2024-12-31

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).

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

Study Design

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

Study Groups

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).

Group Type: EXPERIMENTAL

Blood flow restriction tourniquet

Intervention Type: DEVICE

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

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

Group Type: ACTIVE_COMPARATOR

Evidence based physical/occupational therapy

Intervention Type: OTHER

Up to date physical/occupational therapy for lateral epicondylitis

Interventions

Blood flow restriction tourniquet

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

Intervention Type: DEVICE

Evidence based physical/occupational therapy

Up to date physical/occupational therapy for lateral epicondylitis

Intervention Type: OTHER

Other Intervention Names

Delfi personalized tourniquet system

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cleveland Clinic Akron General

OTHER

Sponsor Role: lead

Responsible Party

Aaron Lear

Director of Primary Care Sports Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aaron Lear, MD, CAQ

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Akron General

Locations

Cleveland Clinic Akron General

Akron, Ohio, United States

Countries

United States

Other Identifiers

19001

Identifier Type: -

Identifier Source: org_study_id