Clinical trial NCT01862731: Muscle Strength Loss and Its Effect on Knee Cap Motion in Volunteers With Anterior Knee Pain
Official title: Vasti Control of Patellofemoral Kinematics in Patients With Chronic Patellofemoral Pain.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patellofemoral Pain Syndrome
Keywords: Muscle Force
Knee
Magnetic Resonance Imaging
Quadriceps
Ultrasound
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2013-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.@@@

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.

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.

Eligibility 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)

Primary outcomes:
measure: PF kinematics and the level of pain experience by the subject
timeFrame: prior to and after a nerve block
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: Frances T Gavelli, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
citation: 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.
citation: 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.