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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with patellofemoral pain syndrome (PFP), which involves pain around the kneecap. Researchers are testing whether a brain stimulation technique, transcranial direct current stimulation (tDCS), combined with exercise, can better prevent the knee from caving in during movement compared to exercise alone. The aim is to determine if this combined approach can enhance traditional treatments for PFP. Individuals who have experienced kneecap pain on one side for at least three months and notice their knee caving in during activities might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve future PFP treatments.

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 prior data suggests that this brain stimulation technique is safe for individuals with patellofemoral pain syndrome?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe. In studies using tDCS, most participants tolerated it well and reported few serious side effects. Common mild side effects include slight tingling on the scalp or mild headaches, which usually resolve quickly.

One study found that tDCS significantly reduced pain compared to a placebo, without causing major issues. Another review examined the safety of tDCS and confirmed its safety when used at the correct dose.

These findings suggest that tDCS is safe, especially when administered properly, making it a promising option for clinical trials in treating knee pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for patellofemoral pain syndrome, like physical therapy and pain medications, aim to relieve symptoms through exercise and pain relief. But Transcranial Direct Current Stimulation (tDCS) works differently, targeting the brain's pain processing centers directly. Researchers are excited about tDCS because it uses a gentle electrical current to potentially reduce pain by altering brain activity, offering a non-invasive alternative without the side effects of medication. This novel approach could pave the way for more effective management of chronic knee pain by tapping into the brain's ability to modulate pain signals.

What evidence suggests that this brain stimulation technique is effective for patellofemoral pain syndrome?

Research has shown that transcranial direct current stimulation (tDCS) combined with exercise can help treat patellofemoral pain syndrome (PFPS). In this trial, participants will receive either tDCS or a sham treatment. Studies have found that combining tDCS with regular knee strengthening exercises can improve treatment outcomes by reducing pain and disability and enhancing scores on the Knee Injury and Osteoarthritis Outcome Score. Additionally, tDCS has increased muscle strength and reduced the sensation of pain. These findings suggest that tDCS could be a promising addition to PFPS treatment. ^{2 4 6 7 8}

Who Is on the Research Team?

Kai Yu Ho, PhD

Principal Investigator

UNLV

Are You a Good Fit for This Trial?

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

Presence of an implanted device that interacts with electric current

History of balance disorder

Current pregnancy or suspicion of pregnancy

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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) 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]

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]

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]

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]

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]

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]

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]

Citations

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Effectiveness of transcranial direct electrical stimulation in ... The results of this study indicate that the treatment of patellofemoral pain syndrome with tDCS can be effective in combination with exercises ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40785962/

Effectiveness of transcranial direct electrical stimulation in ... Results: The results showed that pain, disability, and Knee Injury and Osteoarthritis Outcome Score improved in both the groups. However, the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06729437

Transcranial Direct Current Stimulation on Functionality ... The aim of the present study is to investigate the effectiveness of transcranial direct current stimulation (tDCS) prior to a therapeutic eccentric exercise ...

4. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2024.1427091/full

Exploring the use of bimodal transcranial direct current ... Anodal transcranial direct current stimulation increases muscular strength and reduces pain perception in women with patellofemoral pain. J ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X2500219X

Improving functional outcomes in patellofemoral pain ... The findings suggest that tDCS, when combined with traditional knee strengthing exercises, may enhance treatment efficacy for PFPS. This non- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10813248/

Transcranial Direct Current Stimulation for Orthopedic Pain (1) Background: Transcranial direct current stimulation (tDCS) appears to alleviate chronic pain via a brain-down mechanism.

7. bmjopen.bmj.com bmjopen.bmj.com/content/15/9/e103925

Dosage and safety of transcranial magnetic stimulation ... This scoping review aims to systematically identify and map the stimulation targets and stimulation dosages, and safety profiles of TMS and tDCS used in the ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X22001036

Self-administered transcranial direct current stimulation for ... Active tDCS significantly reduced pain intensity compared to sham tDCS after completion of the fifteen daily sessions (Cohen's d = 1.20; p-value < 0.0001).