Patellofemoral Pain SyndromeNCT01862731
Muscle Strength Loss and Its Effect on Knee Cap Motion in Volunteers With Anterior Knee Pain
An observational study of Patellofemoral Pain Syndrome, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: Researchers are interested in how the muscles affect the movement of the knee cap. These muscles may be related to different kinds of knee pain that are not caused by an injury or a disease. Imaging studies such as magnetic resonance imaging (MRI) can be used to look at these muscles. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2013to 19 Jul 2024
- Phase
- Observational
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants will be recruited primarily from the greater Washington DC area. It will be advertised through clinicaltrials.gov, social media, flyers, and word of mouth.@@@
Who may be able to join
- Male and female volunteers between the ages of 18 and 55
Who cannot join
- All Volunteers
- Any relevant medical problems, including 933 those preventing ambulation
- Any serious injury to the joint being studied, previous surgery on the joint being studiedor extreme pain at the joint being studied or other condition that may explain the presence of PF_pain (e.g., meniscal tear, arthritis)
- Allergy/hypersensitivity to any local anesthetic agent (e.g., Novocain, lidocaine, bupivacaine, ropivacaine)
- Liver disease
- Open angle glaucoma
Show all 18Show fewer
- Cardiac arrhythmias, congenital heart disease
- Glucose-6-phosphate dehydrogenase deficiency
- Any female who is pregnant
- A volunteer will be excluded if they have a contraindication to MR imaging. Examples are:
- Metal within their body, which might be expected to concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field (e.g., aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, cochlear implant, other foreign body (e.g. metal shavings, insulin pump).
- A condition, which would preclude them from participating in an MR imaging study (e.g., paralyzed hemidiaphragm, morbid obesity, severe claustrophobia)
- A condition that presents an unnecessary risk to them or their unborn child (e.g., 953 pregnancy, previous surgery of uncertain type, symptoms of pheochromocytoma or insulinoma)
- Subjects with Chronic Idiopathic Patellofemoral Pai:
- 1. Lack of PFpain (either no active pain or current pain of < 6 months duration)
- Control Volunteers:
- Any clinical signs of a knee impairment in the joint being studied, including abnormal range of motion, muscle weakness, malalignment, and ligament damage.
- The presence of PF_pain (either active or past)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Vasti Control of Patellofemoral Kinematics in Patients With Chronic Patellofemoral Pain.
Background:
- Researchers are interested in how the muscles affect the movement of the knee cap. These muscles may be related to different kinds of knee pain that are not caused by an injury or a disease. Imaging studies such as magnetic resonance imaging (MRI) can be used to look at these muscles. To study these muscles and how they move, researchers will use MRI to look at healthy individuals and individuals with knee cap pain.
Read more
Objectives:
- To study how changes to the muscles around the knee can influence knee pain.
Eligibility:
- Individuals between 18 to 55 years of age who have knee cap pain that cannot be explained by a specific injury or disease.
- Healthy volunteers between 18 and 55 years of age.
Design:
- Participants will be screened with a physical exam and medical history.
- This study requires two visits. Each visit will use standard MRI sequences to take images of the knee in motion and at rest.
- On the first visit, the MRI scan will look at the knee in its natural state. Participants will move the knee up and down for 1 to 3 minutes at a time during the scan.
- On the second visit, a local anesthetic agent will be injected into the muscle of the thigh. The anesthetic will block this muscle from generating force for 2 or 3 hours. Participants will move the knee up and down for 1 to 3 minutes at a time during the MRI scan.
Read the detailed description
Chronic idiopathic patellofemoral pain, a potential precursor to osteoarthritis, is one of the most common problems of the knee. It is characterized by anterior knee pain that is aggravated by deep knee flexion, prolonged sitting, and repetitive flexion/extension. The most widely accepted theory in regards to the source of this pain is that a force imbalance around the knee leads to static patellofemoral malalignment and dynamic patellofemoral maltracking. In turn, this malalignment and maltracking leads to elevated joint contact stresses, which ultimately leads to patellofemoral pain. Current understanding of patellofemoral maltracking is typically focused on static 2D alignment (lateral tilt and displacement). Yet, patellofemoral pain is most often exacerbated during dynamic events and the patella has complete six degrees of freedom in its movement. More recent studies have been able to quantify patellofemoral kinematics during volitional dynamic tasks and demonstrate that the maltracking problem is more complex than originally postulated. Specifically, in patients with patellofemoral pain, altered kinematics are not limited to excessive patellar lateral translation and tilt, but include excessive patellar superior translation along with excessive flexion and valgus rotations. Flexion and valgus are sagittal and coronal plane rotations that cause the superior pole of the patella to shift anteriorly and medially, respectively. Recent work has shown that altered force balance around the knee can indeed lead to maltracking. However, the question remains whether correcting an existing force imbalance around the knee can normalize patellar kinematics and/or reduce pain. The purpose of this study is to determine how temporary iatrogenic loss of force in the vastus lateralis muscle alters the aberrant patellar kinematics in subjects with chronic idiopathic patellofemoral pain.
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Muscle Force, Knee, Magnetic Resonance Imaging, Quadriceps, Ultrasound, Natural History
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1/Control Volunteers | Healthy controls | |
| 2/Volunteers with Pain | Subjects with Chronic Idiopathic Patellofemoral Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
PF kinematics and the level of pain experience by the subject
The change in patellofemoral kinematics, patellofemoral pain, and quadriceps strength pre- and post-muscle block.
Measured: prior to and after a nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study start31 May 2013
- Primary completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Frances T Gavelli, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862731
- Sponsor's protocol ID
- 130099
- Other IDs
- 13-CC-0099
- Status last verified
- 23 Oct 2026
- First submitted
- 23 May 2013
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If other investigators wish to use these data, IRB approval will be sought prior to any data sharing. Data sharing will be done under a waiver of informed consent if (1) the previously signed consent form lacked data sharing information or (2) the consent form contained this information and the participant did not ask that his/her data not be shared. Waiver of consent meets the criteria set out in 45 CFR 46.116(d): The research and data sharing involves no more than minimal risk to the subjects.@@@@@@The waiver or alteration will not adversely affect the rights and welfare of the subjects. Data and samples will have personally identifying information removed.@@@The research could not practicably be carried out without the waiver or alteration.@@@Whenever appropriate, the subjects will be provided with additional pertinent information after@@@participation.
Publications
Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
PubMed 14710506Murphy L, Schwartz TA, Helmick CG, Renner JB, Tudor G, Koch G, Dragomir A, Kalsbeek WD, Luta G, Jordan JM. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum. 2008 Sep 15;59(9):1207-13. doi: 10.1002/art.24021.
PubMed 18759314Hootman JM, Helmick CG. Projections of US prevalence of arthritis and associated activity limitations. Arthritis Rheum. 2006 Jan;54(1):226-9. doi: 10.1002/art.21562.
PubMed 16385518
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasti Control of Patellofemoral Kinematics in Patients With Chronic Patellofemoral Pain.
- ClinicalTrials.gov ID
- NCT01862731
- Acronym / sponsor ID
- 130099
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Muscle Force, Knee, Magnetic Resonance Imaging, Quadriceps, Ultrasound, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 31 May 2013 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- First posted
- 24 May 2013 (estimated)
- 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.
Background:
- Researchers are interested in how the muscles affect the movement of the knee cap. These muscles may be related to different kinds of knee pain that are not caused by an injury or a disease. Imaging studies such as magnetic resonance imaging (MRI) can be used to look at these muscles. To study these muscles and how they move, researchers will use MRI to look at healthy individuals and individuals with knee cap pain.
Objectives:
- To study how changes to the muscles around the knee can influence knee pain.
Eligibility:
- Individuals between 18 to 55 years of age who have knee cap pain that cannot be explained by a specific injury or disease.
- Healthy volunteers between 18 and 55 years of age.
Design:
- Participants will be screened with a physical exam and medical history.
- This study requires two visits. Each visit will use standard MRI sequences to take images of the knee in motion and at rest.
- On the first visit, the MRI scan will look at the knee in its natural state. Participants will move the knee up and down for 1 to 3 minutes at a time during the scan.
- On the second visit, a local anesthetic agent will be injected into the muscle of the thigh. The anesthetic will block this muscle from generating force for 2 or 3 hours. Participants will move the knee up and down for 1 to 3 minutes at a time during the MRI scan.
Detailed description
Chronic idiopathic patellofemoral pain, a potential precursor to osteoarthritis, is one of the most common problems of the knee. It is characterized by anterior knee pain that is aggravated by deep knee flexion, prolonged sitting, and repetitive flexion/extension. The most widely accepted theory in regards to the source of this pain is that a force imbalance around the knee leads to static patellofemoral malalignment and dynamic patellofemoral maltracking. In turn, this malalignment and maltracking leads to elevated joint contact stresses, which ultimately leads to patellofemoral pain. Current understanding of patellofemoral maltracking is typically focused on static 2D alignment (lateral tilt and displacement). Yet, patellofemoral pain is most often exacerbated during dynamic events and the patella has complete six degrees of freedom in its movement. More recent studies have been able to quantify patellofemoral kinematics during volitional dynamic tasks and demonstrate that the maltracking problem is more complex than originally postulated. Specifically, in patients with patellofemoral pain, altered kinematics are not limited to excessive patellar lateral translation and tilt, but include excessive patellar superior translation along with excessive flexion and valgus rotations. Flexion and valgus are sagittal and coronal plane rotations that cause the superior pole of the patella to shift anteriorly and medially, respectively. Recent work has shown that altered force balance around the knee can indeed lead to maltracking. However, the question remains whether correcting an existing force imbalance around the knee can normalize patellar kinematics and/or reduce pain. The purpose of this study is to determine how temporary iatrogenic loss of force in the vastus lateralis muscle alters the aberrant patellar kinematics in subjects with chronic idiopathic patellofemoral pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/Control Volunteers | – | –Healthy controls |
| 2/Volunteers with Pain | – | –Subjects with Chronic Idiopathic Patellofemoral Pain |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants will be recruited primarily from the greater Washington DC area. It will be advertised through clinicaltrials.gov, social media, flyers, and word of mouth.@@@
Key inclusion criteria (1 listed)
Key exclusion criteria (18 listed)
- All Volunteers
- Any relevant medical problems, including 933 those preventing ambulation
- Any serious injury to the joint being studied, previous surgery on the joint being studiedor extreme pain at the joint being studied or other condition that may explain the presence of PF_pain (e.g., meniscal tear, arthritis)
- Allergy/hypersensitivity to any local anesthetic agent (e.g., Novocain, lidocaine, bupivacaine, ropivacaine)
- Liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PF kinematics and the level of pain experience by the subject
Time frame: prior to and after a nerve block
The change in patellofemoral kinematics, patellofemoral pain, and quadriceps strength pre- and post-muscle block.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 14710506Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
- Background: PubMed 18759314Murphy L, Schwartz TA, Helmick CG, Renner JB, Tudor G, Koch G, Dragomir A, Kalsbeek WD, Luta G, Jordan JM. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum. 2008 Sep 15;59(9):1207-13. doi: 10.1002/art.24021.
- Background: PubMed 16385518Hootman JM, Helmick CG. Projections of US prevalence of arthritis and associated activity limitations. Arthritis Rheum. 2006 Jan;54(1):226-9. doi: 10.1002/art.21562.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. If other investigators wish to use these data, IRB approval will be sought prior to any data sharing. Data sharing will be done under a waiver of informed consent if (1) the previously signed consent form lacked data sharing information or (2) the consent form contained this information and the participant did not ask that his/her data not be shared. Waiver of consent meets the criteria set out in 45 CFR 46.116(d): The research and data sharing involves no more than minimal risk to the subjects.@@@@@@The waiver or alteration will not adversely affect the rights and welfare of the subjects. Data and samples will have personally identifying information removed.@@@The research could not practicably be carried out without the waiver or alteration.@@@Whenever appropriate, the subjects will be provided with additional pertinent information after@@@participation.
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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.
Frances T Gavelli, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellofemoral Pain Syndrome, run by National Institutes of Health Clinical Center (CC) 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 1 inclusion and 18 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: finished, as of the sponsor's last update on 27 Oct 2026. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PF kinematics and the level of pain experience by the subject (time frame: prior to and after a nerve block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01862731, which also lists 3 linked publications.
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 27 Oct 2026.