Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2024-02-10
2024-02-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Active stimulation
Low-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction
Active stimulation using low-frequency ultrasonic transducer
The ultrasonic transducer delivers focused low-intensity ultrasound stimulation
Sham stimulation
Zero-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction
Sham stimulation using low-frequency ultrasonic transducer
The ultrasonic transducer delivers focused zero-intensity ultrasound stimulation
Interventions
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Active stimulation using low-frequency ultrasonic transducer
The ultrasonic transducer delivers focused low-intensity ultrasound stimulation
Sham stimulation using low-frequency ultrasonic transducer
The ultrasonic transducer delivers focused zero-intensity ultrasound stimulation
Eligibility Criteria
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Inclusion Criteria
* Moderate-to-severe chronic pain lasting at least 2 months
* Stated willingness to comply with all study procedures and avoid changes to current treatments (medications, physical therapy, cognitive behavioral therapy) for the duration of the study
* For females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study
* Capacity to provide informed consent; provision of a signed and dated consent form
Exclusion Criteria
* Pregnant or breast feeding
* Implanted device in the back
* Lifetime history of a serious suicide attempt
* Clinically inappropriate for participation in the study as determined by the study team
18 Years
70 Years
ALL
No
Sponsors
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University of Utah
OTHER
Responsible Party
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Jan Kubanek
Assistant Professor
Principal Investigators
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Jan Kubanek, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Daniel Odell, MD
Role: STUDY_CHAIR
University of Utah
Locations
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University of Utah
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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IRB_00175546
Identifier Type: -
Identifier Source: org_study_id
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