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

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.

Study Overview

• Status: Recruiting
• Conditions: Patellofemoral Pain Syndrome
• Intervention / Treatment: Device: transcranial direct current stimulator

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kai Yu Ho, PhD; Phone Number: 7028952629; Email: kaiyu.ho@unlv.edu

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89154
      • Recruiting
      • University of Nevada, Las Vegas
      • Contact: Kai Yu Ho; Phone Number: 702-895-2629; Email: kaiyu.ho@unlv.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham	Device: 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.
Experimental: Transcranial Direct Current Stimulation (tDCS)	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
trunk lean angle	Baseline and Immediately after intervention
knee frontal plane projection angle	Baseline and Immediately after intervention
hip frontal plane projection angle	Baseline and Immediately after intervention
dynamic valgus index	Baseline and Immediately after intervention

Collaborators and Investigators

• Sponsor: University of Nevada, Las Vegas
• Investigators: Principal Investigator: Kai Yu Ho, PhD, UNLV

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2024
• Primary Completion (Estimated): April 21, 2025
• Study Completion (Estimated): April 21, 2025

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Patellofemoral Pain Syndrome
• Other Study ID Numbers: UNLV-2022-69

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No