Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome

Patellofemoral Pain Syndrome Clinical Trial

Official title:

Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03717532
• Other study ID #: 18-01123
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: May 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Procedure:
• Placebo
Patients will be receiving blood flow restriction therapy with a pressure cuff set to a placebo pressure setting.
• Personalized Tourniquet System for Blood Flow Restriction
Patients will be receiving blood flow restriction therapy with a pressure cuff

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 Weeks
Primary	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."	6 Weeks