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Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome

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ClinicalTrials.gov Identifier: NCT03717532
Recruitment Status : Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Procedure: Placebo Procedure: Personalized Tourniquet System for Blood Flow Restriction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
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
Procedure: Personalized Tourniquet System for Blood Flow Restriction
Patients will be receiving blood flow restriction therapy with a pressure cuff

Placebo Comparator: Patients with Patellopain syndrome with Placebo Cuff Procedure: Placebo
Patients will be receiving blood flow restriction therapy with a pressure cuff set to a placebo pressure setting.




Primary Outcome Measures :
  1. 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

  2. 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."



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03717532     History of Changes
Other Study ID Numbers: 18-01123
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Somatoform Disorders
Patellofemoral Pain Syndrome
Disease
Pathologic Processes
Mental Disorders
Joint Diseases
Musculoskeletal Diseases