Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome

NCT ID: NCT03717532

Last Updated: 2020-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-11-01

Brief Summary

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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

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Conditions

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Patellofemoral Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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

Group Type EXPERIMENTAL

Personalized Tourniquet System for Blood Flow Restriction

Intervention Type PROCEDURE

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

Patients with Patellopain syndrome with Placebo Cuff

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type PROCEDURE

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

Interventions

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Placebo

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

Intervention Type PROCEDURE

Personalized Tourniquet System for Blood Flow Restriction

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillen Gonzalez-Lomas, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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18-01123

Identifier Type: -

Identifier Source: org_study_id

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