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Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717532
Recruitment Status : Terminated (Inadequate/low enrollment)
First Posted : October 24, 2018
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE October 19, 2018
First Posted Date  ICMJE October 24, 2018
Last Update Posted Date May 28, 2020
Actual Study Start Date  ICMJE February 1, 2019
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2018)
  • Increase in Muscle Mass Measured by Biodex [ Time Frame: 6 Weeks ]
    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) [ Time Frame: 6 Weeks ]
    100-mm horizontal line anchored at one end with the words "no pain" and at the other end with the words "worst pain imaginable."
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome
Official Title  ICMJE Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Patellofemoral Pain Syndrome
Intervention  ICMJE
  • Procedure: Placebo
    Patients will be receiving blood flow restriction therapy with a pressure cuff set to a placebo pressure setting.
  • Procedure: Personalized Tourniquet System for Blood Flow Restriction
    Patients will be receiving blood flow restriction therapy with a pressure cuff
Study Arms  ICMJE
  • Experimental: Patients with Patellopain syndrome with Cuff
    Patient will be prescribed to 6 weeks of physical therapy with a cuff around the affected leg during exercises
    Intervention: Procedure: Personalized Tourniquet System for Blood Flow Restriction
  • Placebo Comparator: Patients with Patellopain syndrome with Placebo Cuff
    Intervention: Procedure: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 26, 2020)
1
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2018)
100
Actual Study Completion Date  ICMJE November 1, 2019
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03717532
Other Study ID Numbers  ICMJE 18-01123
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Time Frame: Beginning 3 months and ending 5 years following article publication.
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guillen Gonzalez-Lomas, MD NYU Langone Medical Center
PRS Account NYU Langone Health
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP