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Ultrasound Therapy

Ultrasound Stimulation for Neuropathic Pain

Phase 1 & 2
Recruiting
Led By Jan Kubanek, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Moderate-to-severe chronic pain lasting at least 2 months
Primary diagnosis of chronic pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after the intervention, and every day thereafter, for 7 days
Awards & highlights

Summary

This trial will use low-intensity ultrasound on spinal nerves in patients with chronic pain. They will find the right ultrasound settings and then test them in a controlled trial. They will measure pain levels using standard

Who is the study for?
This trial is for individuals with a primary diagnosis of chronic neuropathic pain that's been ongoing for at least two months. Participants should be willing to stick to their current treatments without changes and, if female and able to have children, must not be pregnant or agree to use effective contraception.
What is being tested?
The study tests low-intensity focused ultrasound on dorsal root ganglia in patients with chronic pain, using MRI validation. It involves initial testing of various stimulation parameters followed by a blinded comparison between real and sham (fake) stimulations to see which reduces pain better.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort or other sensations at the stimulation site, headache, or temporary changes in mood or sleep patterns due to the nature of neural stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had chronic pain for at least 2 months.
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I have been primarily diagnosed with chronic pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the intervention, and every day thereafter, for 7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the intervention, and every day thereafter, for 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain intensity: momentary change
Pain intensity: subjective state

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active stimulationActive Control1 Intervention
Low-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction
Group II: Sham stimulationPlacebo Group1 Intervention
Zero-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction

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Who is running the clinical trial?

University of UtahLead Sponsor
1,127 Previous Clinical Trials
1,793,157 Total Patients Enrolled
28 Trials studying Chronic Pain
4,793 Patients Enrolled for Chronic Pain
Jan Kubanek, PhDPrincipal InvestigatorUniversity of Utah
2 Previous Clinical Trials
60 Total Patients Enrolled
Daniel Odell, MDStudy ChairUniversity of Utah
~27 spots leftby Apr 2027
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