Patellofemoral Pain SyndromeNCT06565520
Modulating Cortical Excitability to Improve Functional Movements in Individuals With Patellofemoral Pain
A study testing transcranial direct current stimulator in people with Patellofemoral Pain Syndrome, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
This study sought to investigate whether modulation of cortical excitability of the gluteal musculature, via tDCS paired with exercise, will reduce the amount the knee caves in during functional tasks in individuals with PFP. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- transcranial direct current stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2024to 21 Apr 2025
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- are between 18 and 45 years old
- have had patellofemoral pain (PFP; kneecap pain) on one side for at least 3 months, and 3) the knee does cave in when performing functional movements.
Who cannot join
- do not have pain coming from the kneecap during screening;
- have a history of knee injury or surgery,
- have a history of seizures and/or taking anti-seizure medication,
- have an implanted device that interacts with electric current,
- have a history of balance disorder,
- currently are pregnant or think they may be pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Nevada, Las Vegas
Las Vegas, Nevada, 89154
Kai Yu Ho, 702-895-2629, kaiyu.ho@unlv.edu
About this study
Official title: Modulating Cortical Excitability to Improve Functional Movements in Individuals With Patellofemoral Pain: a Randomized Control Trial
This study sought to investigate whether modulation of cortical excitability of the gluteal musculature, via tDCS paired with exercise, will reduce the amount the knee caves in during functional tasks in individuals with PFP. The objective is the explore if having tDCS target the area of the brain controlling hip muscles, when paired with exercise, will be more effective in reducing the amount the knee caves in for individuals with PFP versus those who receive exercise alone as their treatment. The aim is to contribute our findings to the growing knowledge in this area in order to help establish the possibility, and feasibility, of its use in clinical settings to strengthen traditional treatments for this patient population.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- transcranial direct current stimulator
- 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.
transcranial direct current stimulatorDevice
The total amount of participation time per qualified subject will be approximately 150 minutes over two sessions. The participant screening session will take approximately 30 minutes, which is an appropriate amount of time to complete all screening tasks. The tDCS and sham sessions will take approximately a total of 120 minutes over two sessions.
The first session will include a screening (30 minutes) to ensure they qualify for the study, followed by a treatment session (60 minutes): including non-invasive brain stimulation combined with hip strengthening exercises and functional movement testing at UNLV Maryland Campus. Subjects will return for a second treatment session (60 minutes) 2 weeks after the first.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Experimental | Not described Receives: Device: transcranial direct current stimulator |
| Sham | Sham comparator | Not described Receives: Device: transcranial direct current stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
trunk lean angle
Measured: Baseline and Immediately after intervention
knee frontal plane projection angle
Measured: Baseline and Immediately after intervention
hip frontal plane projection angle
Measured: Baseline and Immediately after intervention
dynamic valgus index
Measured: Baseline and Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start24 Apr 2024
- Primary completion21 Apr 2025 (estimated)
- Study completion21 Apr 2025 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai Yu Ho, PhD, Principal investigator, UNLV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565520
- Sponsor's protocol ID
- UNLV-2022-69
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Cortical Excitability to Improve Functional Movements in Individuals With Patellofemoral Pain: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06565520
- Acronym / sponsor ID
- UNLV-2022-69
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 21 Apr 2025 (estimated)
- Study completion
- 21 Apr 2025 (estimated)
- First posted
- 22 Aug 2024 (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 sought to investigate whether modulation of cortical excitability of the gluteal musculature, via tDCS paired with exercise, will reduce the amount the knee caves in during functional tasks in individuals with PFP. The objective is the explore if having tDCS target the area of the brain controlling hip muscles, when paired with exercise, will be more effective in reducing the amount the knee caves in for individuals with PFP versus those who receive exercise alone as their treatment. The aim is to contribute our findings to the growing knowledge in this area in order to help establish the possibility, and feasibility, of its use in clinical settings to strengthen traditional treatments for this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Experimental | Device: transcranial direct current stimulator |
| Sham | Sham comparator | Device: transcranial direct current stimulator |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- are between 18 and 45 years old
- have had patellofemoral pain (PFP; kneecap pain) on one side for at least 3 months, and 3) the knee does cave in when performing functional movements.
Key exclusion criteria (6 listed)
- do not have pain coming from the kneecap during screening;
- have a history of knee injury or surgery,
- have a history of seizures and/or taking anti-seizure medication,
- have an implanted device that interacts with electric current,
- have a history of balance disorder,
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 |
|---|---|---|
| transcranial direct current stimulatorThe total amount of participation time per qualified subject will be approximately 150 minutes over two sessions. The participant screening session will take approximately 30 minutes, which is an appropriate amount of time to complete all screening tasks. The tDCS and sham sessions will take approximately a total of 120 minutes over two sessions. The first session will include a screening (30 minutes) to ensure they qualify for the study, followed by a treatment session (60 minutes): including non-invasive brain stimulation combined with hip strengthening exercises and functional movement testing at UNLV Maryland Campus. Subjects will return for a second treatment session (60 minutes) 2 weeks after the first. | Device | Sham, Transcranial Direct Current Stimulation (tDCS) |
Primary outcome
trunk lean angle
Time frame: Baseline and Immediately after intervention
knee frontal plane projection angle
Time frame: Baseline and Immediately after intervention
hip frontal plane projection angle
Time frame: Baseline and Immediately after intervention
dynamic valgus index
Time frame: Baseline and Immediately after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Kai Yu Ho, PhD principal investigator
UNLV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulator in people with Patellofemoral Pain Syndrome, run by University of Nevada, Las Vegas at 1 site 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 6 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Yu Ho, PhD (7028952629, kaiyu.ho@unlv.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
trunk lean angle (time frame: Baseline and Immediately after intervention). 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 22 Aug 2024.