Recruiting

Cortical Modulation

Sponsor:

University of Nevada, Las Vegas

Code:

NCT06565520

Conditions

Patellofemoral Pain Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

transcranial direct current stimulator

Study Details

Brief 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. 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

Study ID

NCT06565520

Start date

Apr 24, 2024

Status verified date

Aug, 2024

Completion date

Apr 21, 2025

Anticipated

Primary completion date

Apr 21, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transcranial Direct Current Stimulation (tDCS)

sham comparator: Sham

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

University of Nevada, Las Vegas

Recruiting

Las Vegas, Nevada, United States, 89154

Contacts

More Information

Sponsor

University of Nevada, Las Vegas

Last update posted

Aug 22, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nevada, Las Vegas on 2024-08-22.