Patellofemoral Pain SyndromeNCT03717532
Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome
A study testing Personalized Tourniquet System for Blood Flow Restriction in people with Patellofemoral Pain Syndrome, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Personalized Tourniquet System for Blood Flow Restriction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class I-II
- Diagnosed with patellofemoral pain syndrome
Who cannot join
- 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
Show all 9Show fewer
- Patients with Sickle cell anemia or venous thromboembolism
- Patients with cancer or Lymphectomies
- Patients with increased intracranial pressure
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Placebo, Personalized Tourniquet System for Blood Flow Restriction
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboProcedure or surgery
Patients will be receiving blood flow restriction therapy with a pressure cuff set to a placebo pressure setting.
Personalized Tourniquet System for Blood Flow RestrictionProcedure or surgery
Patients will be receiving blood flow restriction therapy with a pressure cuff
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Personalized Tourniquet System for Blood Flow Restriction |
| Patients with Patellopain syndrome with Placebo Cuff | Placebo comparator | Not described Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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."
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Feb 2019
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Why it stopped: Inadequate/low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillen Gonzalez-Lomas, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717532
- Sponsor's protocol ID
- 18-01123
- Status last verified
- May 2020
- First submitted
- 19 Oct 2018
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT03717532
- Acronym / sponsor ID
- 18-01123
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate/low enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Patellopain syndrome with Cuff | Experimental | Procedure: Personalized Tourniquet System for Blood Flow RestrictionPatient will be prescribed to 6 weeks of physical therapy with a cuff around the affected leg during exercises |
| Patients with Patellopain syndrome with Placebo Cuff | Placebo comparator | Procedure: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA class I-II
- Diagnosed with patellofemoral pain syndrome
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPatients will be receiving blood flow restriction therapy with a pressure cuff set to a placebo pressure setting. | Procedure or surgery | Patients with Patellopain syndrome with Placebo Cuff |
| Personalized Tourniquet System for Blood Flow RestrictionPatients will be receiving blood flow restriction therapy with a pressure cuff | Procedure or surgery | Patients with Patellopain syndrome with Cuff |
Primary outcome
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
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."
Results and safety
The study was stopped early (reason given: Inadequate/low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Related trials for Patellofemoral Pain Syndrome
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Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
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Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
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Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillen Gonzalez-Lomas, MD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Tourniquet System for Blood Flow Restriction in people with Patellofemoral Pain Syndrome, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate/low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in Muscle Mass Measured by Biodex (time frame: 6 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.