What side effects are associated with this type of intervention?

Common treatments for osteoarthritis include oral NSAIDs, duloxetine, and intraarticular glucocorticoid injections. Oral NSAIDs can cause gastrointestinal issues, cardiovascular problems, and kidney damage. Duloxetine may lead to nausea, dry mouth, and fatigue. Intraarticular glucocorticoid injections can result in joint infection, increased pain, and cartilage damage. For neuromodulation treatments like tDCS and TUS, side effects are generally mild and may include tingling, lightheadedness, and skin irritation at the site of stimulation.

What prior FDA approvals exist?

There are no specific FDA approvals for the use of transcranial direct current stimulation (tDCS) or transcranial ultrasound (TUS) in the treatment of osteoarthritis. However, the FDA has approved various other treatments for osteoarthritis, including oral nonsteroidal anti-inflammatory drugs (NSAIDs), duloxetine, and intraarticular glucocorticoid injections for short-term pain relief. Neuromodulation techniques like tDCS and TUS are still under investigation for their potential benefits in managing osteoarthritis pain and functional limitations.

What other types of research exist?

Promising, novel alternatives to tDCS and TUS for osteoarthritis patients considering treatment in 2024 include repetitive transcranial magnetic stimulation (rTMS) and vagus nerve stimulation (VNS). rTMS has shown efficacy in various conditions such as depression and tinnitus, and VNS has demonstrated positive outcomes in treatment-resistant depression, which suggests potential benefits for OA pain management.

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Behavioural Intervention

tDCS + TUS for Osteoarthritis

N/A

Waitlist Available

Research Sponsored by Spaulding Rehabilitation Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Existing knee pain of at least 3 on a 0-10 VAS scale on average over the past 6 months.

Diagnosis of chronic osteoarthritis with pain of either knee as self-reported.

Must not have

Epilepsy.

Use of carbamazepine within the past 6 months as self-reported.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Summary

This trial investigates if using small electrical currents and sound waves on the brain can reduce pain and improve function in people with knee osteoarthritis.

Who is the study for?

This trial is for adults aged 18-85 with chronic knee pain from osteoarthritis, resistant to common painkillers. Participants must have a self-reported diagnosis of osteoarthritis and a minimum average pain level of 3 on the VAS scale. Excluded are those with unexplained fainting, neurosurgery history, recent substance abuse, brain device implants, unstable medical conditions like uncontrolled diabetes or heart issues, epilepsy, recent carbamazepine use, pregnancy or severe depression.

What is being tested?

The study tests if active low-intensity transcranial electrical stimulation (tDCS) combined with transcranial ultrasound (TUS) can reduce pain perception in knee osteoarthritis compared to sham (fake) treatments. The hypothesis suggests that active stimulation will lower pain levels more effectively than non-active treatment.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site on the scalp, headache during or after treatment sessions and possible skin irritation beneath the electrodes used for tDCS. However specific side effects related to this trial's interventions aren't detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had knee pain rated at least 3 out of 10 for the past 6 months.

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I have long-term knee pain from arthritis.

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My pain doesn't improve with common painkillers like Tylenol or Ibuprofen.

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My average pain level was 3 or more last week.

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I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have epilepsy.

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I have not taken carbamazepine in the last 6 months.

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I do not have any uncontrolled health issues like diabetes or heart problems.

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I have severe depression, as indicated by my high score on a depression test.

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I have had brain surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Average Daily Dose of Acetaminophen Equivalent

Changes in Pain Scale as Measured by VAS

Percentage Change From Baseline in the Single Leg Standing Balance Test

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Electrical Stim/Active UltrasoundExperimental Treatment1 Intervention

Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.

Group II: Sham Electrical Stim/Sham UltrasoundPlacebo Group1 Intervention

Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Osteoarthritis (OA) treatments aim to reduce pain and improve joint function. Physical therapy enhances muscle strength and joint flexibility, while intraarticular glucocorticoid injections reduce inflammation. Surgery, such as total knee replacement, is considered when other treatments fail. Neuromodulation techniques like Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS) are emerging therapies. tDCS modulates neuronal activity by applying a low electrical current to the scalp, potentially altering pain perception and improving mood. TUS uses sound waves to influence brain activity, which may also modulate pain pathways. These neuromodulation techniques are significant for OA patients as they offer non-invasive options that target central pain mechanisms, potentially providing relief when traditional treatments are insufficient.