Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neural Correlates of Knee Sensorimotor Control in Patients With Patelleofemoral Pain Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099004
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
Patellofemoral pain (PFP) is a chronic condition characterized by retro- or peri-patellar pain during everyday activities that load the patellofemoral joint, such as sitting, jumping, or walking. PFP is one of the most common knee conditions affecting the general population, affects approximately 1 out of 4 school aged youth and is more common in females. The pain associated with PFP adversely affects daily activities, reduces physical activity, and may contribute to patellofemoral osteoarthritis. Participants with PFP exhibit aberrant biomechanics during functional movement which may be, in part, due to altered brain activity in response to movement-associated pain. Participants with knee injuries do exhibit depressed sensorimotor brain activity in response to patella displacement relative to healthy controls, but these findings are limited as patella displacement is dissimilar to functional movement (e.g., flexing the knee and hip to get out of a chair). The investigators have successfully developed paradigms to assess knee motor control during functional movement (see methods below) using functional magnetic resonance imaging (fMRI) in healthy participants with no knee pain. The investigators aim to replicate these paradigms in those with PFP to assess this populations' neurophysiologic response to knee movement. Results from this investigation will assist in refining subsequent training and prevention programs to promote more adaptive neuroplasticity.

Condition or disease
Patellofemoral Pain Syndrome Patello Femoral Syndrome Patellofemoral Syndrome

Detailed Description:

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Group/Cohort
PFP Subjects
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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" [0] to "strongly agree" [4] (12). This gives a possible total raw score range from 0 to 52.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only females will be recruited for this study as they are 2 to 10 times more likely to develop PFP than males
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
30 healthy female volunteers with PFP
Criteria

Inclusion Criteria:

  • • Normal female healthy volunteer aged 7-40

    • Able to provide written consent
    • Diagnosed with patellofemoral pain (PFP) or anterior knee pain by a medical professional

Exclusion Criteria:

  • • History of neurological deficits or severe head trauma

    • Braces or permanent metal dental work
    • Insulin pump
    • Cardiac pacemaker
    • Cochlear implants
    • Hearing aids
    • Aneurysm clips
    • Orthopedic pins, wires, screws, or plates inserted within the last 6 months.
    • If you have not been diagnosed with PFP by a medical professional

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099004


Contacts
Layout table for location contacts
Contact: Kim D Barber Foss, MS 5136365971 kim.foss@cchmc.org
Contact: Jed Diekfuss, PhD jed.diekfuss@cchmc.org

Locations
Layout table for location information
United States, Ohio
Cincinanti Childrens Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Kim D Barber Foss, MS    513-636-5971    kim.foss@cchmc.org   
Principal Investigator: Gregory D Myer, PhD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Layout table for investigator information
Principal Investigator: Gregory D Myer, PhD Cincinnati Childrens Hospital
  Study Documents (Full-Text)

Documents provided by Children's Hospital Medical Center, Cincinnati:
Study Protocol  [PDF] April 15, 2019

Layout table for additonal information
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT04099004    
Other Study ID Numbers: 2017-5776
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Patellofemoral Pain Syndrome
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Joint Diseases
Musculoskeletal Diseases