Back to resultsBlood Flow Restriction Therapy in Patellofemoral Pain Syndrome
Primary Purpose
Patellofemoral Pain Syndrome
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
Personalized Tourniquet System for Blood Flow Restriction
Sponsored by
About this trial
This is an interventional treatment trial for Patellofemoral Pain Syndrome
Eligibility Criteria
Inclusion Criteria:
- ASA class I-II
- Diagnosed with patellofemoral pain syndrome
Exclusion Criteria:
- Patients with confirmed radiographic evidence explaining knee pain
- Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
- Younger than 18 years of age or older than 65
- Any patient considered a vulnerable subject
- Patients with impaired circulation, peripheral vascular compromise, Previous revascularization of the extremity, or severe hypertension
- Patients with Sickle cell anemia or venous thromboembolism
- Patients with Sickle cell anemia or venous thromboembolism
- Patients with cancer or Lymphectomies
- Patients with increased intracranial pressure
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Patients with Patellopain syndrome with Cuff
Patients with Patellopain syndrome with Placebo Cuff
Arm Description
Patient will be prescribed to 6 weeks of physical therapy with a cuff around the affected leg during exercises
Outcomes
Primary Outcome Measures
Increase in Muscle Mass Measured by Biodex
Biodex dynamometer is used under standard of care to measure the extensor strength of both legs and have bilateral thigh circumference measured
Decrease in Pain measured by Visual Analog Scale (VAS)
100-mm horizontal line anchored at one end with the words "no pain" and at the other end with the words "worst pain imaginable."
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03717532
Brief Title
Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome
Official Title
Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
Inadequate/low enrollment
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy of blood restriction therapy by comparing increase in muscle mass and strength in patients that receive blood restriction therapy to patients who receive a placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with Patellopain syndrome with Cuff
Arm Type
Experimental
Arm Description
Patient will be prescribed to 6 weeks of physical therapy with a cuff around the affected leg during exercises
Arm Title
Patients with Patellopain syndrome with Placebo Cuff
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
Patients will be receiving blood flow restriction therapy with a pressure cuff set to a placebo pressure setting.
Intervention Type
Procedure
Intervention Name(s)
Personalized Tourniquet System for Blood Flow Restriction
Intervention Description
Patients will be receiving blood flow restriction therapy with a pressure cuff
Primary Outcome Measure Information:
Title
Increase in Muscle Mass Measured by Biodex
Description
Biodex dynamometer is used under standard of care to measure the extensor strength of both legs and have bilateral thigh circumference measured
Time Frame
6 Weeks
Title
Decrease in Pain measured by Visual Analog Scale (VAS)
Description
100-mm horizontal line anchored at one end with the words "no pain" and at the other end with the words "worst pain imaginable."
Time Frame
6 Weeks
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:
ASA class I-II
Diagnosed with patellofemoral pain syndrome
Exclusion Criteria:
Patients with confirmed radiographic evidence explaining knee pain
Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
Younger than 18 years of age or older than 65
Any patient considered a vulnerable subject
Patients with impaired circulation, peripheral vascular compromise, Previous revascularization of the extremity, or severe hypertension
Patients with Sickle cell anemia or venous thromboembolism
Patients with Sickle cell anemia or venous thromboembolism
Patients with cancer or Lymphectomies
Patients with increased intracranial pressure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillen Gonzalez-Lomas, MD
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
Learn more about this trial
Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome
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