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

Primary Purpose

Lateral Epicondylitis

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Blood flow restriction tourniquet

Evidence based physical/occupational therapy

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring lateral epicondylitis, tennis elbow, blood flow restriction, physical therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Cleveland Clinic Akron General

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blood flow restriction with physical/occupational therapy

Evidence based physical/occupational therapy

Arm Description

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

evidence based physical/occupational therapy program over 6 visits (within a twelve week period) without use of blood flow restriction tourniquet

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Numeric pain rating scale

change in score on 0-10 pain rating scale with 0 being no pain, and 10 being worst pain.

Pain free grip strength

Change in pain free grip strength on dynamometer

Maximum grip strength

Change in maximum grip strength on dynamometer

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

Full Information

NCT ID

NCT03978897

First Posted

May 24, 2019

Last Updated

August 2, 2023

Sponsor

Cleveland Clinic Akron General

1. Study Identification

Unique Protocol Identification Number

NCT03978897

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

August 1, 2024 (Anticipated)

Study Completion Date

August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cleveland Clinic Akron General

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lateral Epicondylitis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Blood flow restriction with physical/occupational therapy

Arm Type

Experimental

Arm Description

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

Arm Title

Evidence based physical/occupational therapy

Arm Type

Active Comparator

Arm Description

evidence based physical/occupational therapy program over 6 visits (within a twelve week period) without use of blood flow restriction tourniquet

Intervention Type

Device

Intervention Name(s)

Blood flow restriction tourniquet

Other Intervention Name(s)

Delfi personalized tourniquet system

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Evidence based physical/occupational therapy

Intervention Description

Up to date physical/occupational therapy for lateral epicondylitis

Primary Outcome Measure Information:

Title

Patient rated tennis elbow evaluation (PRTEE)

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Numeric pain rating scale

Description

change in score on 0-10 pain rating scale with 0 being no pain, and 10 being worst pain.

Time Frame

12 months

Title

Pain free grip strength

Description

Change in pain free grip strength on dynamometer

Time Frame

at final therapy visit up to 12 weeks after enrollment

Title

Maximum grip strength

Description

Change in maximum grip strength on dynamometer

Time Frame

at final therapy visit up to 12 weeks after enrollment

Title

Other treatments received

Description

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

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aaron Lear, MD, CAQ

Organizational Affiliation

Cleveland Clinic Akron General

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Akron General

City

Akron

State/Province

Ohio

ZIP/Postal Code

44307

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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