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Protocol Details

Vasti Control of Patellofemoral Kinematics in Patients with Chronic Patellofemoral Pain.

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-CC-0099

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 55

Referral Letter Required

No

Population Exclusion(s)

Children;
Pregnant Women and Fetuses

Special Instructions

Currently Not Provided

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Patellofemoral Pain Syndrome

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

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.

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Eligibility

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)


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Citations:

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

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.

Hootman JM, Helmick CG. Projections of US prevalence of arthritis and associated activity limitations. Arthritis Rheum. 2006 Jan;54(1):226-9.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Frances Gavelli, Ph.D.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Two Democracy Plaza
Room 201A
6707 Democracy Boulevard
Bethesda, Maryland 20817
(301) 451-7585
gavellif@cc.nih.gov

Frances Gavelli, Ph.D.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Two Democracy Plaza
Room 201A
6707 Democracy Boulevard
Bethesda, Maryland 20817
(301) 451-7585
gavellif@cc.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01862731

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