Neural Correlates of Knee Sensorimotor Control in Patients With Patellofemoral Pain Syndrome
2 other identifiers
interventional
15
1 country
2
Brief Summary
This study aims to determine the neural correlates of knee motor control in young females with patellofemoral pain (PFP). Each participant will attend a single study visit which may last up to 3 hours.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 16, 2017
CompletedFirst Submitted
Initial submission to the registry
April 11, 2019
CompletedFirst Posted
Study publicly available on registry
September 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedFebruary 13, 2024
February 1, 2024
6.1 years
April 11, 2019
February 12, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Resting State Blood Oxygen Level Dependent (BOLD) Signal
Brain activity while the participant is lying still will be assessed as the BOLD signal obtained using fMRI.
Day 1 (during MRI session)
Blood Oxygen Level Dependent (BOLD) Signal During Flexion/Extension Movement
Brain activity while participants complete a combined knee and hip flexion/extension movement will be assessed as the BOLD signal obtained using fMRI.
Day 1 (during MRI session)
Blood Oxygen Level Dependent (BOLD) Signal During Quadriceps Contraction
Brain activity while participants complete a a quadriceps contraction task will be assessed as the BOLD signal obtained using fMRI. For the quadriceps contraction task, participants are asked to 'squeeze' their quadriceps while keeping the rest of their body still.
Day 1 (during MRI session)
Blood Oxygen Level Dependent (BOLD) Signal During Pain Inducing Tasks
Brain activity while participants complete pain inducing tasks will be assessed as the BOLD signal obtained using fMRI. The pain inducing tasks involve the researcher placing one hand above the participants' knee and applying intermittent pressure to their quadriceps and medial aspect of the patella.
Day 1 (during MRI session)
Secondary Outcomes (4)
Pain Scale Score
Day 1 (during MRI session)
Anterior Knee Pain Scale (AKPS) Score
Day 1 (during MRI session)
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Score
Day 1 (during MRI session)
Tampa Scale of Kinesiophobia (TSK) Score
Day 1 (during MRI session)
Study Arms (1)
Neural Imaging
OTHERFemales with PFP attending a single study visit where neural imaging is acquired via MRI.
Interventions
During the acquisition of magnetic resonance (MR) images, the study participants will lie on the scanner table. For most portions of MR acquisition, the study participants will be instructed to lie still. For other parts of the acquisition, study participants will be asked to complete a combined knee and hip flexion/extension movement and a quadriceps contraction task in which they will be asked to 'squeeze' their quadriceps while keeping the rest of their body still. For the last 15 minutes of MR acquisition, the researcher will place one hand above the participants' knee and apply intermittent pressure to their quadriceps and medial aspect of the patella. Pain scales will be administered after every fMRI task to assess subjective perceptions of pain. Peripheral pulse oximetry and respiration waveforms will be collected for data analysis in order to minimize the potential confounding effect from the physiological changes.
Eligibility Criteria
You may qualify if:
- Diagnosed with patellofemoral pain (PFP) or anterior knee pain by a medical professional
- Able to provide written consent
You may not qualify if:
- Any contraindications to MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (2)
Emory Healthcare Sports Performance And Research Center (SPARC)
Flowery Branch, Georgia, 30542, United States
Cincinanti Childrens Hospital Medical Center (CCHMC)
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory D Myer, PhD
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 11, 2019
First Posted
September 23, 2019
Study Start
November 16, 2017
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
February 13, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share