Modulating Cortical Excitability to Improve Functional Movements in Individuals With Patellofemoral Pain

NCT ID: NCT06565520

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-24

Study Completion Date

2025-04-21

Brief Summary

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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.

Detailed Description

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Conditions

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Patellofemoral Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Transcranial Direct Current Stimulation (tDCS)

Group Type EXPERIMENTAL

transcranial direct current stimulator

Intervention Type DEVICE

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.

Sham

Group Type SHAM_COMPARATOR

transcranial direct current stimulator

Intervention Type DEVICE

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.

Interventions

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transcranial direct current stimulator

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. are between 18 and 45 years old
2. 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.

Exclusion Criteria

1. do not have pain coming from the kneecap during screening;
2. have a history of knee injury or surgery,
3. have a history of seizures and/or taking anti-seizure medication,
4. have an implanted device that interacts with electric current,
5. have a history of balance disorder,
6. currently are pregnant or think they may be pregnant.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nevada, Las Vegas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kai Yu Ho, PhD

Role: PRINCIPAL_INVESTIGATOR

UNLV

Locations

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University of Nevada, Las Vegas

Las Vegas, Nevada, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kai Yu Ho, PhD

Role: CONTACT

7028952629

Facility Contacts

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Kai Yu Ho

Role: primary

702-895-2629

Other Identifiers

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UNLV-2022-69

Identifier Type: -

Identifier Source: org_study_id

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