Brain Stimulation for Patellofemoral Pain Syndrome
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Nevada, Las Vegas
Must not be taking: Anti-seizure
Disqualifiers: Knee injury, Seizures, Pregnancy, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
678910How 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.
1241112Eligibility 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.
I am between 18 and 45 years old.
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
+3 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transcranial Direct Current Stimulation (tDCS)Experimental Treatment1 Intervention
Group II: ShamPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Nevada, Las VegasLas Vegas, NV
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Who Is Running the Clinical Trial?
University of Nevada, Las VegasLead Sponsor
References
Anodal Transcranial Direct Current Stimulation Increases Muscular Strength and Reduces Pain Perception in Women With Patellofemoral Pain. [2023]Rodrigues, GM, Paixão, A, Arruda, T, de Oliveira, BRR, Maranhão Neto, GA, Marques Neto, SR, Lattari, E, and Machado, S. Anodal transcranial direct current stimulation increases muscular strength and reduces pain perception in women with patellofemoral pain. J Strength Cond Res 36(2): 371-378, 2022-The purpose of this study is to investigate the effects of anodic transcranial direct current stimulation applied to motor cortex combined with open kinetic chain exercises on muscular strength and pain perception in women with patellofemoral pain (PFP). Twenty-eight women aged between 18 and 30 years with PFP were selected. Subjects were randomized in 2 groups, anodic stimulus plus resistance training (n = 14; anodic transcranial direct current stimulation [a-tDCS] + RT) or placebo stimulus plus resistance training (n = 14; Sham + RT) and attended the laboratory for 12 experimental sessions, 48-72 hours apart from each other. The RT protocol consisted of 3 sets of 12 repetitions of the knee extension exercise at 60% of 10 maximal repetition (10RM) with a 1-minute interval between sets. In the a-tDCS + RT group, a 2-mA current was applied for 20 minutes over the motor cortex before the RT protocol in each session. In the Sham + RT group, the stimulus was interrupted after 30 seconds. Preintervention, fourth session, eighth session, and postintervention, load was assessed through a 10RM test. The pain perception was assessed through Clarke sign maneuver (CSM) and measured through a visual analogue scale for pain. The a-tDCS + RT group showed greater 10RM load than Sham + RT group at eighth session (p
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]Previous studies have indicated that transcranial direct current stimulation (tDCS) with the anode over the motor cortex and the cathode over the contralateral supraorbital region is effective in reducing clinical pain in patients with chronic pain, but these studies have not focused on experimental pain sensitivity. Therefore, the aim of this study was to examine the effect of tDCS on experimental pain sensitivity in older adults with knee osteoarthritis (OA).
Transcranial Direct Current Stimulation for Knee Osteoarthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]The effects of transcranial direct current stimulation (tDCS) in the treatment of knee osteoarthritis (KOA) is still unclear.
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]Although evidence has indicated a positive effect of transcranial direct current stimulation (tDCS) on reducing pain, few studies have focused on the elderly population with knee osteoarthritis (KOA).
The effects of anodal tDCS on pain reduction in people with knee osteoarthritis: A systematic review and meta-analysis. [2023]To synthesise the literature on the efficacy of primary motor cortex anodal transcranial direct current stimulation (M1-a-tDCS), as a standalone or priming technique, for pain reduction in people with knee osteoarthritis (KOA).
A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]Transcranial direct current stimulation (tDCS) is a non-invasive method of brain stimulation that has been intensively investigated in clinical and cognitive neuroscience. Although the general impression is that tDCS is a safe technique with mild and transient adverse effects (AEs), human data on safety and tolerability are largely provided from single-session studies in healthy volunteers. In addition the frequency of AEs and its relationship with clinical variables is unknown. With the aim of assessing tDCS safety in different conditions and study designs, we performed a systematic review and meta-analysis of tDCS clinical trials. We assessed Medline and other databases and reference lists from retrieved articles, searching for articles from 1998 (first trial with contemporary tDCS parameters) to August 2010. Animal studies, review articles and studies assessing other neuromodulatory techniques were excluded. According to our eligibility criteria, 209 studies (from 172 articles) were identified. One hundred and seventeen studies (56%) mentioned AEs in the report. Of these studies, 74 (63%) reported at least one AE and only eight studies quantified AEs systematically. In the subsample reporting AEs, the most common were, for active vs. sham tDCS group, itching (39.3% vs. 32.9%, p>0.05), tingling (22.2% vs. 18.3%, p>0.05), headache (14.8% vs. 16.2%, p>0.05), burning sensation (8.7% vs. 10%, p>0.05) and discomfort (10.4% vs. 13.4%, p>0.05). Meta-analytical techniques could be applied in only eight studies for itching, but no definite results could be obtained due to between-study heterogeneity and low number of studies. Our results suggested that some AEs such as itching and tingling were more frequent in the tDCS active group, although this was not statistically significant. Although results suggest that tDCS is associated with mild AEs only, we identified a selective reporting bias for reporting, assessing and publishing AEs of tDCS that hinders further conclusions. Based on our findings, we propose a revised adverse effects questionnaire to be applied in tDCS studies in order to improve systematic reporting of tDCS-related AEs.
Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]Transcranial direct current stimulation (tDCS) is reported to induce irritating skin sensations and occasional skin injuries, which limits the applied tDCS dose. Additionally, tDCS hardware safety profile prevents high current delivery when skin resistance is high.
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose-response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3-13 A/m(2)) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 milliamperes, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations.
Does anodal transcranial direct current stimulation modulate sensory perception and pain? A meta-analysis study. [2022]The primary aim of this systematic review was to evaluate the effects of anodal transcranial direct current stimulation (a-tDCS) on sensory (STh) and pain thresholds (PTh) in healthy individuals and pain levels (PL) in patients with chronic pain.
Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. [2023]Transcranial direct current stimulation (tDCS) has considerable potential as a useful method in the field of neurorehabilitation. However, the safety of tDCS for the human is primarily based on theoretical evidence related to electricity, and the safety information of applying tDCS to the human is only available from researcher's reporting. Based on tDCS studies with human and animal subjects and simulation-based studies of the safety of current stimulation in the past 20 years, this review investigated the safety of tDCS application to the human body. No severe complications have been reported in either adults or children for tDCS at an intensity of 4 mA or less, within a period of 60 minutes per day, using commonly applied 25 or 35 cm2 electrodes. According to animal studies, the amount of electricity used for tDCS is less than 5% of the amount that permanently changes brain tissue, thereby ensuring safety to a certain extent. In order to increase the efficacy of tDCS for neurorehabilitation and to minimize even trivial complications in the human screening of exclusion criteria should be conducted with detailed observations of complications.
Transcranial direct-current stimulation reduces nociceptive behaviour in an orofacial pain model. [2019]Transcranial direct-current stimulation (tDCS) is a noninvasive method of brain stimulation suggested as a therapeutic tool for pain and is related to the reversal of maladaptive plasticity associated with chronic pain.
Anodal transcranial direct current stimulation of the motor cortex ameliorates chronic pain and reduces short intracortical inhibition. [2022]Consecutive sessions of transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) may be a suitable therapy to treat chronic pain, as it can modulate neural activities in the stimulated and interconnected regions.