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Blood Flow Restriction & Tennis Elbow Rehab

Primary Purpose

Lateral Epicondylitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Flow Restriction Device
Standard Physical Therapy
Sponsored by
Julie Nuelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Ages 18-65 years of age
  2. Diagnosis of lateral epicondylitis confirmed by the treating orthopaedic surgeon and ultrasound
  3. Must be able to read and write in English
  4. Able to provide own written consent

Exclusion Criteria:

  1. Patients over 65 years of age
  2. Contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength or daily pain greater than 1/10
  3. History of prior injection for treatment of lateral epicondylitis
  4. Pregnancy
  5. Recent history of deep venous thrombosis (within the past 12 months)
  6. Active treatment with anticoagulants
  7. History of upper quadrant lymph node dissection
  8. History of endothelial dysfunction
  9. Patient history of easy bruising
  10. Active infection in the injured arm
  11. Cancer
  12. Uncontrolled peripheral vascular disease
  13. Uncontrolled diabetes mellitus

Sites / Locations

  • University of Missouri Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Physical Therapy

Blood Flow Restricted Physical Therapy

Arm Description

For patients enrolled in the control group, the participants will undergo calibration of the Delfi Personalized Tourniquet System to measure limb occlusion pressure and will wear the cuff during completion of the exercises with minimal inflation (approximately 5%), to hold the cuff in place during treatment. This will act as a sham.

Physical therapy assisted by blood flow restriction per standard physical therapy protocol.

Outcomes

Primary Outcome Measures

Define the effect of BFR training on pain with activity in patients with LE.
Measured on a 0-10 scale by VAS (Visual Analog Scale) patient reported outcome form. The VAS is scored 0-10, and a higher score indicates worse pain/worse outcomes.

Secondary Outcome Measures

Full Information

First Posted
December 27, 2021
Last Updated
November 1, 2022
Sponsor
Julie Nuelle
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1. Study Identification

Unique Protocol Identification Number
NCT05237869
Brief Title
Blood Flow Restriction & Tennis Elbow Rehab
Official Title
Blood Flow Restricted Training to Enhance Lateral Epicondylitis Rehabilitation.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Julie Nuelle

4. Oversight

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

5. Study Description

Brief Summary
Lateral epicondylitis (LE), often referred to as "tennis elbow" is a common and debilitating overuse injury affecting 1-3% of adults annually. LE is most often defined as a syndrome of pain near the area of the lateral epicondyle of the elbow commonly effecting the origin of the extensor carpi radialis brevis with associated weakness; it most commonly effects the dominant arm. The best treatment for LE is unknown and research to support current treatment methods are insufficient. A common limitation in functional recovery experienced by this population is pain at the lateral aspect of the elbow. As such, innovative therapeutic interventions directed at quickly reducing pain may address this unmet need and allow for improved outcomes, as well as earlier return to function.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
For patients enrolled in the control group, the participants will undergo calibration of the Delfi Personalized Tourniquet System to measure limb occlusion pressure and will wear the cuff during completion of the exercises with minimal inflation (approximately 5%), to hold the cuff in place during treatment. This will act as a sham.
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical Therapy
Arm Type
Sham Comparator
Arm Description
For patients enrolled in the control group, the participants will undergo calibration of the Delfi Personalized Tourniquet System to measure limb occlusion pressure and will wear the cuff during completion of the exercises with minimal inflation (approximately 5%), to hold the cuff in place during treatment. This will act as a sham.
Arm Title
Blood Flow Restricted Physical Therapy
Arm Type
Active Comparator
Arm Description
Physical therapy assisted by blood flow restriction per standard physical therapy protocol.
Intervention Type
Device
Intervention Name(s)
Blood Flow Restriction Device
Intervention Description
Occlusion training involves the application of a cuff to the upper arm that is designed to restrict only the low-pressure blood flow in veins. It does not prevent blood flowing from the heart to the arm.
Intervention Type
Other
Intervention Name(s)
Standard Physical Therapy
Intervention Description
Standard physical therapy protocol for lateral epicondylitis rehab without blood flow restriction.
Primary Outcome Measure Information:
Title
Define the effect of BFR training on pain with activity in patients with LE.
Description
Measured on a 0-10 scale by VAS (Visual Analog Scale) patient reported outcome form. The VAS is scored 0-10, and a higher score indicates worse pain/worse outcomes.
Time Frame
3 weeks to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 18-65 years of age Diagnosis of lateral epicondylitis confirmed by the treating orthopaedic surgeon and ultrasound Must be able to read and write in English Able to provide own written consent Exclusion Criteria: Patients over 65 years of age Contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength or daily pain greater than 1/10 History of prior injection for treatment of lateral epicondylitis Pregnancy Recent history of deep venous thrombosis (within the past 12 months) Active treatment with anticoagulants History of upper quadrant lymph node dissection History of endothelial dysfunction Patient history of easy bruising Active infection in the injured arm Cancer Uncontrolled peripheral vascular disease Uncontrolled diabetes mellitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacee Baker, BSN, RN
Phone
5738849017
Email
bakersa@umsystem.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Nuelle, MD
Organizational Affiliation
University of Missouri Department of Orthopaedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Health System
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacee Baker, MEd BSN RN
Phone
573-884-9017
Email
bakersa@umsystem.edu

12. IPD Sharing Statement

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Blood Flow Restriction & Tennis Elbow Rehab

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