Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome

Not Applicable

Terminated

• Conditions: Patellofemoral Pain Syndrome
• Interventions: Procedure: Placebo; Procedure: Personalized Tourniquet System for Blood Flow Restriction

• Registration Number: NCT03717532
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-22
• Study First Posted: 2018-10-24
• Study Start: 2019-02-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• ASA class I-II
• Diagnosed with patellofemoral pain syndrome

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with Patellopain syndrome with Placebo Cuff	Placebo	-
Patients with Patellopain syndrome with Cuff	Personalized Tourniquet System for Blood Flow Restriction	Patient will be prescribed to 6 weeks of physical therapy with a cuff around the affected leg during exercises

Primary Outcome Measures

Name	Time	Method
Decrease in Pain measured by Visual Analog Scale (VAS)	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."
Increase in Muscle Mass Measured by Biodex	6 Weeks	Biodex dynamometer is used under standard of care to measure the extensor strength of both legs and have bilateral thigh circumference measured

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States