Brain Stimulation for Patellofemoral Pain Syndrome

Overseen By Kai Yu Ho, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Nevada, Las Vegas

Must not be taking: Anti-seizure

Disqualifiers: Knee injury, Seizures, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking anti-seizure medication.

What data supports the effectiveness of the treatment Transcranial Direct Current Stimulation (tDCS) for Patellofemoral Pain Syndrome?

Research shows that using transcranial direct current stimulation (tDCS) can increase muscle strength and reduce pain in women with patellofemoral pain. Additionally, tDCS has been effective in reducing pain in other conditions like knee osteoarthritis, suggesting it may help with patellofemoral pain as well. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with mild and temporary side effects like itching, tingling, and headaches. Studies have shown no serious adverse effects when used at standard levels (up to 4 milliamperes for 40 minutes) across a wide range of people, including potentially vulnerable groups. ^{6 7 8 9 10}

How does the treatment transcranial direct current stimulation (tDCS) differ from other treatments for patellofemoral pain syndrome?

Transcranial direct current stimulation (tDCS) is unique because it is a noninvasive brain stimulation technique that can enhance muscular strength and reduce pain perception by modulating brain activity, unlike traditional treatments that may focus solely on physical therapy or medication. ^{1 2 4 11 12}

What is the purpose of this 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.

Research Team

Kai Yu Ho, PhD

Principal Investigator

UNLV

Eligibility Criteria

This trial is for individuals with Patellofemoral Pain Syndrome (PFP), which often causes knee pain and discomfort. Participants should be experiencing knee caving in during physical activities. The study is not suitable for those who cannot safely receive transcranial direct current stimulation or exercise therapy.

Inclusion Criteria

I have had pain in my kneecap for at least 3 months.

My knee buckles during activities like walking or climbing stairs.

Exclusion Criteria

History of balance disorder

I have had a knee injury or surgery in the past.

Current pregnancy or suspicion of pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial direct current stimulation (tDCS) paired with exercise to modulate cortical excitability and improve functional movements

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Transcranial Direct Current Stimulator

Trial Overview The trial tests if using a brain-stimulating device called a transcranial direct current stimulator (tDCS) can improve how the hip muscles work to prevent the knee from caving in when paired with exercise, compared to just doing exercises alone.

Participant Groups

Group I: Transcranial Direct Current Stimulation (tDCS) Experimental Treatment 1 Intervention

Group II: Sham Placebo Group 1 Intervention

Transcranial Direct Current Stimulator is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transcranial Direct Current Stimulation for:

• Chronic pain management
• Neurological rehabilitation
• Musculoskeletal pain relief

Approved in European Union as Transcranial Direct Current Stimulation for:

• Chronic pain management
• Neurological rehabilitation
• Musculoskeletal pain relief

Approved in Canada as Transcranial Direct Current Stimulation for:

• Chronic pain management
• Neurological rehabilitation
• Musculoskeletal pain relief

Who Is Running the Clinical Trial?

University of Nevada, Las Vegas

Lead Sponsor

Trials

81

Recruited

14,700+

Findings from Research

Anodal transcranial direct current stimulation (a-tDCS) combined with resistance training significantly increased muscular strength in women with patellofemoral pain (PFP), as evidenced by greater 10RM loads compared to the placebo group after 8 sessions and post-intervention.

The same a-tDCS + resistance training intervention also led to a significant reduction in pain perception after treatment, indicating its potential effectiveness in rehabilitation programs for PFP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anodal Transcranial Direct Current Stimulation Increases Muscular Strength and Reduces Pain Perception in Women With Patellofemoral Pain. Rodrigues, GM., Paixão, A., Arruda, T., et al.[2023]

In a study involving 40 older adults with knee osteoarthritis, transcranial direct current stimulation (tDCS) significantly increased pain thresholds and tolerances, indicating its efficacy in reducing experimental pain sensitivity.

The improvements in experimental pain measures from tDCS were linked to reductions in clinical pain, suggesting that tDCS could be a promising non-invasive treatment for managing chronic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bayesian analysis of the effect of transcranial direct current stimulation on experimental pain sensitivity in older adults with knee osteoarthritis: randomized sham-controlled pilot clinical study. Ahn, H., Suchting, R., Woods, AJ., et al.[2022]

Transcranial direct current stimulation (tDCS) significantly reduced pain in patients with knee osteoarthritis (KOA) compared to sham treatment, with a standardized mean difference of -0.62, indicating its potential as an effective pain management option.

However, tDCS did not show significant improvements in physical function, stiffness, mobility performance, or quality of life, suggesting that while it may help with pain relief, it does not enhance overall physical capabilities in KOA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation for Knee Osteoarthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Yang, JM., Li, CC., Wang, Y., et al.[2023]

Transcranial direct current stimulation (tDCS) significantly reduced knee osteoarthritis pain in elderly individuals with a dysfunctional descending pain inhibitory system, showing a moderate effect size after 15 daily sessions.

The tDCS intervention was well tolerated with no severe adverse effects, and it also improved pain modulation, although the benefits were not sustained after the follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor cortex transcranial direct current stimulation effects on knee osteoarthritis pain in elderly subjects with dysfunctional descending pain inhibitory system: A randomized controlled trial. Tavares, DRB., Okazaki, JEF., Santana, MVA., et al.[2021]

Anodal transcranial direct current stimulation (M1-a-tDCS) has been shown to significantly reduce pain in individuals with knee osteoarthritis (KOA), with a moderate effect size in a meta-analysis of 14 studies involving 740 participants.

M1-a-tDCS can be effective both as a standalone treatment and when combined with other therapies, although the overall certainty of these findings is low due to potential biases and small sample sizes in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of anodal tDCS on pain reduction in people with knee osteoarthritis: A systematic review and meta-analysis. Dissanayaka, T., Nakandala, P., Malwanage, K., et al.[2023]

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Anodal transcranial direct current stimulation (a-tDCS) applied to the primary motor cortex significantly increases sensory and pain thresholds in healthy individuals, with effect sizes of 22.19% and 19.28%, respectively.

In patients with chronic pain, a-tDCS applied to the primary motor cortex and dorsolateral prefrontal cortex resulted in a significant reduction in pain levels, with an average decrease in pain scores of 14.9% and 19.3%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does anodal transcranial direct current stimulation modulate sensory perception and pain? A meta-analysis study. Vaseghi, B., Zoghi, M., Jaberzadeh, S.[2022]

Transcranial direct current stimulation (tDCS) has been found to be safe for use in humans, with no severe complications reported in studies involving both adults and children when applied at intensities of 4 mA or less for up to 60 minutes.

Animal studies indicate that the electrical current used in tDCS is significantly lower than the threshold that could cause permanent changes to brain tissue, suggesting a strong safety profile for this neurorehabilitation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. Ko, MH.[2023]

Transcranial direct-current stimulation (tDCS) significantly reduced both mechanical and thermal hyperalgesia in a rat model of orofacial inflammatory pain, showing effectiveness in pain management up to 7 days post-treatment.

The treatment with tDCS led to increased levels of neurotrophic factors (BDNF and NGF) and anti-inflammatory cytokines (IL-6 and IL-10) in the brainstem, suggesting a mechanism of action that involves modulation of neuroplasticity and inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct-current stimulation reduces nociceptive behaviour in an orofacial pain model. Scarabelot, VL., de Oliveira, C., Medeiros, LF., et al.[2019]

Five consecutive days of anodal transcranial direct current stimulation (tDCS) over the primary motor cortex significantly improved pain ratings in patients with chronic pain, with effects lasting three to four weeks post-treatment.

The study showed that anodal tDCS decreased intracortical inhibition, indicating enhanced cortical excitability, and no severe adverse effects were reported, suggesting it is a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anodal transcranial direct current stimulation of the motor cortex ameliorates chronic pain and reduces short intracortical inhibition. Antal, A., Terney, D., Kühnl, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Anodal Transcranial Direct Current Stimulation Increases Muscular Strength and Reduces Pain Perception in Women With Patellofemoral Pain. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Bayesian analysis of the effect of transcranial direct current stimulation on experimental pain sensitivity in older adults with knee osteoarthritis: randomized sham-controlled pilot clinical study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation for Knee Osteoarthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Motor cortex transcranial direct current stimulation effects on knee osteoarthritis pain in elderly subjects with dysfunctional descending pain inhibitory system: A randomized controlled trial. [2021]

5. France pubmed.ncbi.nlm.nih.gov

The effects of anodal tDCS on pain reduction in people with knee osteoarthritis: A systematic review and meta-analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Does anodal transcranial direct current stimulation modulate sensory perception and pain? A meta-analysis study. [2022]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Transcranial direct-current stimulation reduces nociceptive behaviour in an orofacial pain model. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Anodal transcranial direct current stimulation of the motor cortex ameliorates chronic pain and reduces short intracortical inhibition. [2022]