NCT04099004

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

6.1 years

First QC Date

April 11, 2019

Last Update Submit

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

OTHER

Females with PFP attending a single study visit where neural imaging is acquired via MRI.

Other: Neural Imaging

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.

Neural Imaging

Eligibility Criteria

Age7 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Study Sites (2)

Emory Healthcare Sports Performance And Research Center (SPARC)

Flowery Branch, Georgia, 30542, United States

Location

Cincinanti Childrens Hospital Medical Center (CCHMC)

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Gregory D Myer, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

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

Locations