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Behavioural Intervention

active low-intensity transcranial electrical stimulation/active transcranial ultrasound 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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study Summary

This trial will study whether transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) can help to relieve pain and improve function in people with osteoarthritis of the knee.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor

134 Previous Clinical Trials

10,951 Total Patients Enrolled

4 Trials studying Osteoarthritis

190 Patients Enrolled for Osteoarthritis

Highland Instruments, Inc.Industry Sponsor

9 Previous Clinical Trials

449 Total Patients Enrolled

2 Trials studying Osteoarthritis

66 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be an optimal candidate for participation in this medical research?

"To qualify for enrolment, participants must demonstrate symptoms of arthrosis and fall between the ages 18-85. This trial is expecting to accept a total of 64 patients."

Answered by AI

Is the eligibility for this investigation limited to persons aged 35 and under?

"In line with the study's criteria, people 18 years of age or older and below 85 are eligible to take part."

Answered by AI

Is there still an opportunity to partake in this experiment?

"As reported on clinicaltrials.gov, this medical experiment is not presently enrolling patients; it was initially published on 9th September 2016 and last updated 8th August 2022. However, there are 1,007 alternative trials actively recruiting participants at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of tDCS and tUS on Pain Perception in OA of the Knee

Felipe Fregni, MD, PhD, MPH 2016. "Effects of tDCS and tUS on Pain Perception in OA of the Knee". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02723929.

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