Muscle Strength Loss and Its Effect on Knee Cap Motion in Volunteers With Anterior Knee Pain

NCT01862731 | Completed

• 2 other identifiers: 13009913-CC-0099
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Patellofemoral Pain Syndrome

Keywords

Muscle Force; Knee; Magnetic Resonance Imaging; Quadriceps; Ultrasound; Natural History

Outcome Measures

Primary Outcomes (1)

• 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.

  prior to and after a nerve block

Study Arms (2)

1/Control Volunteers

Healthy controls

2/Volunteers with Pain

Subjects with Chronic Idiopathic Patellofemoral Pain

Eligibility Criteria

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

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.@@@

You may qualify if:

• Male and female volunteers between the ages of 18 and 55

You may not qualify if:

• 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
• 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:
• \. Lack of PF\_pain (either no active pain or current pain of \< 6 months duration)

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 Publications (3)

• Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.

  PMID: 14710506 BACKGROUND

• Murphy 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.

  PMID: 18759314 BACKGROUND

• Hootman 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.

  PMID: 16385518 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

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: May 23, 2013
• First Posted: May 24, 2013
• Study Start: May 31, 2013
• Primary Completion: July 19, 2024
• Last Updated: April 20, 2026

Record last verified: 2025-12-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Data will be shared through data sharing agreements.@@@@@@@@@@@@The start and end date will be determined by the data sharing agreement.
• Access Criteria: Data will be shared stripped of PII and with IRB approval.

Locations

US (1)