- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03717532
Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome
May 26, 2020 updated by: NYU Langone Health
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Langone Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
Patients will be receiving blood flow restriction therapy with a pressure cuff
|
Placebo Comparator: Patients with Patellopain syndrome with Placebo Cuff
|
Patients will be receiving blood flow restriction therapy with a pressure cuff set to a placebo pressure setting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 Weeks
|
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."
|
6 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guillen Gonzalez-Lomas, MD, NYU Langone Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Actual)
November 1, 2019
Study Completion (Actual)
November 1, 2019
Study Registration Dates
First Submitted
October 19, 2018
First Submitted That Met QC Criteria
October 22, 2018
First Posted (Actual)
October 24, 2018
Study Record Updates
Last Update Posted (Actual)
May 28, 2020
Last Update Submitted That Met QC Criteria
May 26, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-01123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patellofemoral Pain Syndrome
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Lauren EricksonAmerican College of Sports MedicineCompleted
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Laval UniversityCompletedPatellofemoral Pain (PFPS)Canada
-
Nationwide Children's HospitalCompletedPatellofemoral Pain Syndrome | Knee Pain Chronic | Anterior Knee Pain Syndrome | Patellofemoral SyndromeUnited States
-
Istanbul Medipol University HospitalCompletedPatellofemoral Pain Syndrome | Patellofemoral Pain | Anterior Knee Pain Syndrome | Patellofemoral Syndrome | Kinesiotape | Orthotic DevicesTurkey
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University of MelbourneNational Health and Medical Research Council, AustraliaCompletedKnee Pain | Patellofemoral PainAustralia
-
Universidade Federal do CearáNot yet recruitingPatellofemoral Pain SyndromeBrazil
-
University of Central LancashireCompletedPatellofemoral PainUnited Kingdom
-
Universidade Federal do CearáCompletedPatellofemoral Pain SyndromeBrazil
-
European University CyprusCompleted
-
Universidade Federal do Rio Grande do NorteUnknown
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-
Children's Healthcare of AtlantaRecruiting
-
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Candice Dunkin, MS, LAT, ATCParkview HealthRecruiting
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Major Extremity Trauma Research ConsortiumActive, not recruitingClosed Femur FractureUnited States
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University of MichiganCompletedAnterior Cruciate Ligament InjuryUnited States
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University of Alabama at BirminghamActive, not recruitingHip Fractures | Muscle AtrophyUnited States
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Connecticut Children's Medical CenterCompletedACL Injury | Blood Flow Restriction | ACL TearUnited States