active low-intensity transcranial electrical stimulation/active transcranial ultrasound for Arthrosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Arthrosis+1 More
active low-intensity transcranial electrical stimulation/active transcranial ultrasound - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Arthrosis
  • Chronic Pain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

0 Primary · 6 Secondary · Reporting Duration: 8 weeks

8 weeks
Average Daily Dose of Acetaminophen Equivalent
Week 4
Changes in Pain Scale as Measured by VAS
Baseline and 8 weeks
Percentage Change From Baseline in the Single Leg Standing Balance Test
Percentage Change From Baseline in the Step Test
Percentage Change in Diffuse Noxious Inhibitory Controls (DNIC) From Baseline
Percentage Change in Functional Reach Test From Baseline

Trial Safety

Trial Design

2 Treatment Groups

Active Electrical Stim/Active Ultrasound
1 of 2
Sham Electrical Stim/Sham Ultrasound
1 of 2
Experimental Treatment
Non-Treatment Group

64 Total Participants · 2 Treatment Groups

Primary Treatment: active low-intensity transcranial electrical stimulation/active transcranial ultrasound · Has Placebo Group · N/A

Active Electrical Stim/Active Ultrasound
Device
Experimental Group · 1 Intervention: active low-intensity transcranial electrical stimulation/active transcranial ultrasound · Intervention Types: Device
Sham Electrical Stim/Sham Ultrasound
Device
ShamComparator Group · 1 Intervention: Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks

Who is running the clinical trial?

Highland Instruments, Inc.Industry Sponsor
9 Previous Clinical Trials
445 Total Patients Enrolled
Spaulding Rehabilitation HospitalLead Sponsor
123 Previous Clinical Trials
10,412 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The study includes participants who are 18 to 85 years old.
The individual reports that they have chronic osteoarthritis and that it causes them pain in their knees.
The person experiences knee pain on a regular basis that is usually at least a 3 on a 0-10 scale.
The patient has pain that is resistant to common analgesics such as Tylenol, Aspirin, Ibuprofen, and Codeine
The person understands the risks and benefits of participating in the study and is able to make an informed decision about whether or not to participate.
The participants reported an average pain score of at least three on a zero to ten visual analogue scale over the week prior to the first stimulation session.
Feeling pain as self-reported.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: October 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.