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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 55 Years
Gender All
More Inclusion & Exclusion Criteria

  • -

    INCLUSION CRITERIA:

    1.
Male and female volunteers between the ages of 18 and 55.

EXCLUSION CRITERIA:

All Volunteers. 1. Any relevant medical problems, including 933 those preventing ambulation. 2. 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) 3. Allergy/hypersensitivity to any local anesthetic agent (e.g., Novocain, lidocaine, bupivacaine, ropivacaine) 4. Liver disease. 5. Open angle glaucoma. 6. Cardiac arrhythmias, congenital heart disease. 7. Glucose-6-phosphate dehydrogenase deficiency. 8. Any female who is pregnant.A volunteer will be excluded if they have a contraindication to MR imaging. Examples are: 1. 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). 2. A condition, which would preclude them from participating in an MR imaging study (e.g., paralyzed hemidiaphragm, morbid obesity, severe claustrophobia) 3. 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 PF_pain (either no active pain or current pain of < 6 months duration) Control Volunteers: 1. Any clinical signs of a knee impairment in the joint being studied, including abnormal range of motion, muscle weakness, malalignment, and ligament damage. 2. The presence of PF_pain (either active or past)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01862731
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Institutes of Health Clinical Center (CC)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Frances Gavelli, Ph.D.
Principal Investigator Affiliation National Institutes of Health Clinical Center (CC)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Patellofemoral Pain Syndrome
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: 1/Control Volunteers

Healthy controls

: 2/Volunteers with Pain

Subjects with Chronic Idiopathic Patellofemoral Pain

Interventions

Contact a Trial Team

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Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892