Neural Correlates of Knee Sensorimotor Control in Patients With Patelleofemoral Pain Syndrome
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|ClinicalTrials.gov Identifier: NCT04099004|
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : February 7, 2020
|Condition or disease|
|Patellofemoral Pain Syndrome Patello Femoral Syndrome Patellofemoral Syndrome|
All MRI scanning will be performed on 3 Tesla Philips MRI scanners (3T Achieva in S-Building and 3T Ingenia in T-Building) located in Imaging Research Center (IRC) in the Cincinnati Children's Hospital Research Foundation (CCHRF). Sedation will not be used for any of the test visits. The entire MRI protocol will include high resolution T1-weighted 3D images, a 61 direction diffusion tensor imaging sequence, resting state fMRI, and task-based fMRI. The fMRI tasks will be focused on motor function, participants will be asked to lower extremity movements such as hip and knee flexion and extension. Also, for 15 minutes, the researcher will place one hand above the participants' knee and apply intermittent pressure to their quadriceps and medial aspect of the patella. VAS scales will be administered after every fMRI task to assess subjective perceptions of pain. The MR scan will be completed in 75 minutes or less. Peripheral pulse oximetry and respiration waveforms will be collected for data analysis in order to minimize the potential confounding effect from the physiological changes. A practice session of the fMRI paradigms will be completed just prior to scanning to allow the participant to ask any questions and be familiar with the protocol.
The hardware and software are not FDA cleared, but also not FDA regulated as they are not medical devices. According to the FDA, a medical device is intended to diagnosis and or treat diseases while affecting the structure or function of any part of the body (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm). This is not the case for our study as participants will already be diagnosed with PFP by a medical professional and the protocol will not alter any function or structure of the human body. the leg press task is simply used to facilitate naturally occurring movement of the leg and hip and not intended to treat patellofemoral pain. This method is simply to further understanding of the neural mechanisms underlying natural movement in this population.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Neural Correlates of Knee Sensorimotor Control in Patients With Patellofemoral Pain Syndrome|
|Actual Study Start Date :||November 16, 2017|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||June 30, 2021|
We aim to recruit approximately 30 healthy female volunteers with PFP. Only females will be recruited for this study as they are 2 to 10 times more likely to develop PFP than males. Females participants with PFP (age 7-40 years old) will be recruited from local school districts local sports clubs and teams, local colleges, adult sport leagues, and professional sports teams, through our well established network with area coaches and athletic trainers
- TBSS measured Change in MRI BOLD signal [ Time Frame: 2 years ]brain activity during our knee movement and pain inducing tasks using functional magnetic resonance imaging (fMRI; the blood oxygen level dependent [BOLD] signal and functional brain connectivity of the BOLD signal obtained from the resting-state fMRI sequence
- Change in Anterior Knee Pain Scale (AKPS) Questionnaire [ Time Frame: 2 years ]) perceived movement dysfunction and disability related to knee pain using the Anterior Knee Pain (AKPS) scale. Scale score ranged from 0-100 with 100 being the best score possible.
- Change in International Knee Documentation Committee (IKDC) Questionnaire [ Time Frame: 2 years ]) perceived movement dysfunction and disability related to knee pain using the International Knee Documentation Committee subjective knee form (IKDC). The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)
- Change in Tampa Scale of Kinesiophobia Questionnaire [ Time Frame: 2 years ]) perceived movement dysfunction and disability related to knee pain using the Tampa Scale of Kinesiophobia (TSK) The Tampa scale of kinesiophobia (TSK). A 13-item questionnaire aimed at the assessment of fear of movement/re-injury. Each item is provided with a 4-points Likert scale with scoring alternatives ranging from "strongly disagree"  to "strongly agree"  (12). This gives a possible total raw score range from 0 to 52.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099004
|Contact: Kim D Barber Foss, MSemail@example.com|
|Contact: Jed Diekfuss, PhDfirstname.lastname@example.org|
|United States, Ohio|
|Cincinanti Childrens Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Kim D Barber Foss, MS 513-636-5971 email@example.com|
|Principal Investigator: Gregory D Myer, PhD|
|Principal Investigator:||Gregory D Myer, PhD||Cincinnati Childrens Hospital|