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临床试验/NCT01862731
NCT01862731已完成不适用

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

National Institutes of Health Clinical Center (CC)1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2013年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
PF kinematics and the level of pain experience by the subject

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • INCLUSION CRITERIA:
  • Male and female volunteers between the ages of 18 and 55

排除标准

  • 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:
  • 1. Lack of PF_pain (either no active pain or current pain of < 6 months duration)
  • Control Volunteers:
  • Any clinical signs of a knee impairment in the joint being studied, including abnormal range of motion, muscle weakness, malalignment, and ligament damage.
  • The presence of PF_pain (either active or past)

研究组 & 干预措施

1/Control Volunteers

Healthy controls

2/Volunteers with Pain

Subjects with Chronic Idiopathic Patellofemoral Pain

结局指标

主要结局

PF kinematics and the level of pain experience by the subject

时间窗: prior to and after a nerve block

The change in patellofemoral kinematics, patellofemoral pain, and quadriceps strength pre- and post-muscle block.

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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