Vasti Control of Patellofemoral Kinematics in Asymptomatic Volunteer

NCT00978003 | Completed

• 2 other identifiers: 09021709-CC-0217
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

• Patellofemoral pain syndrome is one of the most common knee problems. It is characterized by pain in the front of the knee that is aggravated by deep knee flexion, prolonged sitting, and repetitive movement. The most widely accepted theory regarding the source of this pain is that a force imbalance around the knee puts extra stress on the area, leading to pain.
• Researchers are interested in learning more about the muscle groups around the knee to better understand the causes of knee pain. Objectives: \- To obtain more information on how muscles, tendons, and bones work together to cause motion in the knee, both in the normal state and after immobilizing certain muscles around the knee. Eligibility: \- Healthy individuals between the ages of 18 and 55, who have no current or chronic muscle, bone, or joint problems and who have no implants or other problems that would prevent them from receiving a magnetic resonance imaging (MRI) scan. Design:
• This protocol will be carried out over two visits, both of which will involve using standard MRI sequences to look at the knee at rest and in motion.
• The first part will examine the knee under its natural state, with a standard MRI scan of the knee both at rest and in motion.
• The second part will involve temporarily reducing the force producing capabilities of one of the extensor muscles in the knee. To do so, study doctors will inject lidocaine into the muscle, which will temporarily (for approximately 2 hours) block the force producing capacity of this muscle, and then perform the MRI scan.

Conditions

Abnormalities; Patellofemoral Pain Syndrome

Keywords

Maltracking; Anterior Knee Pain; Knee; Natural History

Outcome Measures

Primary Outcomes (1)

• Eliminating the force producing capacity of the VM will increase patellar lateral shift, lateral tilt and valgus rotation.

  MRI imaging followed by muscle block and ultrasound.

  End of study

Secondary Outcomes (1)

• The amount of increase in patellar lateral shift, lateral tilt and valgus rotation, seen with the loss of the VM muscle will be correlated with the inferior- superior position of the patella relative to the femur.

  End of study

Study Arms (1)

1/Healthy Volunteers

Adults age 18-55.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects for this study will be recruited through the Patient Recruitment and Public Liaison (PRPL) office. PRPL will respond to clinical research study inquiries, conduct preliminary screening for the protocol, and refer prospective patients to the Protocol Manager.

You may qualify if:

• Healthy male and female volunteers between the ages of 18 and 55.
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You may not qualify if:

• Any relevant medical problems (connective tissue problems, active arthritis, etc.)
• Any clinical signs of a knee impairment in the joint being studied, including abnormal range of motion, muscle weakness, malaligment, and ligament damage.
• Any serious injury to the joint being studied, previous surgery on the joint being studied or extreme pain at the joint being studied.
• Allergy/hypersensitivity to lidocaine.
• Liver disease.
• Open angle glaucoma.
• Cardiac arrhythmias, congenital heart disease.
• G6PD.
• Any female who is pregnant.
• A volunteer will be excluded if they have a contraindication to MR imaging. Examples include:
• 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, ccular 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., pregnancy, previous surgery of uncertain type, symptoms of pheochromocytoma or insulinoma).

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Congenital Abnormalities; Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Frances T Gavelli, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 16, 2009
• Study Start: October 22, 2009
• Last Updated: April 14, 2026

Record last verified: 2025-12-04

Locations

US (1)