active low-intensity transcranial electrical stimulation/active transcranial ultrasound for Arthrosis
Phase-Based Progress Estimates
Effectiveness
Safety
Arthrosis+1 More
active low-intensity transcranial electrical stimulation/active transcranial ultrasound - DeviceEligibility
18+
All Sexes
What conditions do you have?
Select
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
Other trials for Arthrosis
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
Safety Progress
Other trials for Arthrosis
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: DeviceSham Electrical Stim/Sham Ultrasound
Device
ShamComparator Group · 1 Intervention: Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound · Intervention Types: DeviceTrial 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 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.
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