Patellofemoral Pain SyndromeNCT04099004
Neural Correlates of Knee Sensorimotor Control in Patients With Patellofemoral Pain Syndrome
A study testing Neural Imaging in people with Patellofemoral Pain Syndrome and Patellofemoral Pain, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 40 years, women only
- Conditions the study is for
- Patellofemoral Pain Syndrome, Patellofemoral Pain
- What is being tested?
- Neural Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Nov 2017to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with patellofemoral pain (PFP) or anterior knee pain by a medical professional
- Able to provide written consent
Who cannot join
- Any contraindications to MRI
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinanti Childrens Hospital Medical Center (CCHMC)
Cincinnati, Ohio, 45229
Emory Healthcare Sports Performance And Research Center (SPARC)
Flowery Branch, Georgia, 30542
About this study
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.
Read the detailed description
Patellofemoral pain (PFP) is one of the most common reported knee conditions in adolescents and young adults. PFP can affect nearly 30% of young adults and most frequently affect those who participate in athletic activities involving running, jumping, and cutting. Pain during movement also adversely influences patellofemoral joint loading as evidenced by increased frontal and transverse plane hip motion during activities of daily living. While the biomechanical and anatomical components contributing to knee pain have been well established, the underlying neural mechanisms are less understood. For adults with chronic pain (e.g., osteoarthritis), patients often exhibit greater 'pain network (e.g., anterior cingulate cortex, thalamus)' activation during sensory testing relative to healthy controls, possibly due to long term peripheral receptor activation resulting in hypersensitivity. Further, inducing pain (e.g., pressing on a thumbnail) results in similar neural activation of the pain network for those who have chronic pain symptoms.
While these studies have been imperative to the understanding of pain on neural functioning, they are limited to those specific populations (e.g., fibromyalgia, osteoarthritis) and do not adequately replicate the pain experienced during daily activities. Traditional approaches consisting of bracing and physical therapy focused on strengthening the knee extensors have been unsuccessful in reducing pain. Further, interventions consisting of exercise therapy have not been effective for all patients with PFP, and other pain-reduction techniques, such as direct electrical stimulation of the motor cortex, have failed to produce improved motor function or long-lasting pain relief. The researchers of this study hypothesize that this is due to the failure to appropriately challenge the full sensorimotor network involved in processing sensory and cognitive stimuli for motor control. To effectively treat pain and manage this condition, the neural correlates of pain and sensorimotor knee control in those with PFP is needed.
To appropriately assess the pain network for those with PFP, replicating knee and hip motion while neural function is measured is needed. The research team has successfully developed a combined knee and hip extension and flexion task that can be used safely with functional magnetic resonance imaging (fMRI). The researchers hypothesize that those with PFP will display depressed sensorimotor activity and increased pain network activity during the knee and hip flexion and extension task relative to previously collected data.
The study visit will consist of one magnetic resonance imaging (MRI) session using a GE SIGNA™ Premier 3.0 Tesla MR scanner. The MRI portion of the study visit will be completed in 75 minutes or less, and the entire visit will last up to 3 hours.
- Conditions
- Patellofemoral Pain Syndrome, Patellofemoral Pain
- Being tested
- Neural Imaging
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural ImagingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Neural Imaging | Other | Females with PFP attending a single study visit where neural imaging is acquired via MRI. Receives: Other: Neural Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 (during MRI session)
Secondary outcomes (4)
Pain Scale Score
Participants reporting experiencing pain lasting longer than several days in the past two weeks complete a 4-item survey rating current, average, lowest and highest pain levels. Responses are given on a 5-point scale where 1 = no pain and 5 = worst pain possible. Total scores range from 4 to 20 and higher scores indicate greater pain.
Measured: Day 1 (during MRI session)
Anterior Knee Pain Scale (AKPS) Score
Perceived movement dysfunction and disability related to knee pain is assessed using the Anterior Knee Pain (AKPS) scale. The AKPS has 13 items that are scored on scales of 0 to 5 or 0 to 10. Total scores range from 0 to 100 with 100 indicating the best knee function possible.
Measured: Day 1 (during MRI session)
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Score
Perceived movement dysfunction and disability related to knee pain is assessed using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form. The IKDC is a 10-item, patient-completed tool which contains sections on knee symptoms, knee function, and sports activities. 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).
Measured: Day 1 (during MRI session)
Tampa Scale of Kinesiophobia (TSK) Score
Participant perceived movement dysfunction and disability related to knee pain is assessed using the Tampa Scale of Kinesiophobia (TSK). The TSK is a 17-item questionnaire assessing the fear of movement and re-injury. Responses are given on a 4-point Likert scale where 1 = strongly disagree and 4 = strongly agree. Total scores range from 14 to 68 where higher scores indicate greater concern of re-injury.
Measured: Day 1 (during MRI session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start16 Nov 2017
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Greg Myer, Emory University
- Investigators
- Gregory D Myer, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099004
- Sponsor's protocol ID
- STUDY00001773
- Other IDs
- 2017-5776
- Status last verified
- Feb 2024
- First submitted
- 11 Apr 2019
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Knee Sensorimotor Control in Patients With Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT04099004
- Acronym / sponsor ID
- STUDY00001773
- Conditions
- Patellofemoral Pain Syndrome, Patellofemoral Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patellofemoral pain (PFP) is one of the most common reported knee conditions in adolescents and young adults. PFP can affect nearly 30% of young adults and most frequently affect those who participate in athletic activities involving running, jumping, and cutting. Pain during movement also adversely influences patellofemoral joint loading as evidenced by increased frontal and transverse plane hip motion during activities of daily living. While the biomechanical and anatomical components contributing to knee pain have been well established, the underlying neural mechanisms are less understood. For adults with chronic pain (e.g., osteoarthritis), patients often exhibit greater 'pain network (e.g., anterior cingulate cortex, thalamus)' activation during sensory testing relative to healthy controls, possibly due to long term peripheral receptor activation resulting in hypersensitivity. Further, inducing pain (e.g., pressing on a thumbnail) results in similar neural activation of the pain network for those who have chronic pain symptoms.
While these studies have been imperative to the understanding of pain on neural functioning, they are limited to those specific populations (e.g., fibromyalgia, osteoarthritis) and do not adequately replicate the pain experienced during daily activities. Traditional approaches consisting of bracing and physical therapy focused on strengthening the knee extensors have been unsuccessful in reducing pain. Further, interventions consisting of exercise therapy have not been effective for all patients with PFP, and other pain-reduction techniques, such as direct electrical stimulation of the motor cortex, have failed to produce improved motor function or long-lasting pain relief. The researchers of this study hypothesize that this is due to the failure to appropriately challenge the full sensorimotor network involved in processing sensory and cognitive stimuli for motor control. To effectively treat pain and manage this condition, the neural correlates of pain and sensorimotor knee control in those with PFP is needed.
To appropriately assess the pain network for those with PFP, replicating knee and hip motion while neural function is measured is needed. The research team has successfully developed a combined knee and hip extension and flexion task that can be used safely with functional magnetic resonance imaging (fMRI). The researchers hypothesize that those with PFP will display depressed sensorimotor activity and increased pain network activity during the knee and hip flexion and extension task relative to previously collected data.
The study visit will consist of one magnetic resonance imaging (MRI) session using a GE SIGNA™ Premier 3.0 Tesla MR scanner. The MRI portion of the study visit will be completed in 75 minutes or less, and the entire visit will last up to 3 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neural Imaging | Other | Other: Neural ImagingFemales with PFP attending a single study visit where neural imaging is acquired via MRI. |
Who may qualify
- Ages
- 7 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosed with patellofemoral pain (PFP) or anterior knee pain by a medical professional
- Able to provide written consent
Key exclusion criteria (1 listed)
- Any contraindications to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neural ImagingDuring 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. | Other | Neural Imaging |
Primary outcome
Resting State Blood Oxygen Level Dependent (BOLD) Signal
Time frame: Day 1 (during MRI session)
Brain activity while the participant is lying still will be assessed as the BOLD signal obtained using fMRI.
Blood Oxygen Level Dependent (BOLD) Signal During Flexion/Extension Movement
Time frame: Day 1 (during MRI session)
Brain activity while participants complete a combined knee and hip flexion/extension movement will be assessed as the BOLD signal obtained using fMRI.
Blood Oxygen Level Dependent (BOLD) Signal During Quadriceps Contraction
Time frame: Day 1 (during MRI session)
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.
Blood Oxygen Level Dependent (BOLD) Signal During Pain Inducing Tasks
Time frame: Day 1 (during MRI session)
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.
4 secondary outcomes
Pain Scale Score
Time frame: Day 1 (during MRI session)
Anterior Knee Pain Scale (AKPS) Score
Time frame: Day 1 (during MRI session)
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Score
Time frame: Day 1 (during MRI session)
Tampa Scale of Kinesiophobia (TSK) Score
Time frame: Day 1 (during MRI session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Patellofemoral Pain Syndrome
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Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
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MRI Study of Musculoskeletal Function
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Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
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Stabilization vs Corrective Exercise in PFP
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Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory D Myer, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural Imaging in people with Patellofemoral Pain Syndrome and Patellofemoral Pain, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting State Blood Oxygen Level Dependent (BOLD) Signal (time frame: Day 1 (during MRI session)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.