Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome

NCT03717532 | Terminated

• 1 other identifier: 18-01123
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellofemoral Pain Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Patients with Patellopain syndrome with Cuff

EXPERIMENTAL

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 with Patellopain syndrome with Placebo Cuff

PLACEBO COMPARATOR

Procedure: Placebo

Interventions

Placebo PROCEDURE

Patients will be receiving blood flow restriction therapy with a pressure cuff set to a placebo pressure setting.

Patients with Patellopain syndrome with Placebo Cuff

Personalized Tourniquet System for Blood Flow Restriction PROCEDURE

Patients will be receiving blood flow restriction therapy with a pressure cuff

Patients with Patellopain syndrome with Cuff

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Guillen Gonzalez-Lomas, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 24, 2018
• Study Start: February 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following article publication.

Locations

US (1)