Investigations of Low-Intensity Focused Ultrasound Towards Treatment for the Complex Patient

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Males and females aged 18-65 years

• Current diagnosis of Chronic Back Pain as defined by pain duration of at least three months, with back pain being an ongoing problem for at least half the days of the last six months.

• Have evidence of central sensitization (CS) as measured by the Widespread Pain/Symptom Severity Index (WPSSI) with a score of Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI = 3-6 and SS ≥ 9.

• Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current opiate use disorder as diagnosed by the Structured Clinical Interview for DSM-5.

• Be in treatment for opioid use disorder (OUD) including buprenorphine or methadone.

• Meet the DSM-5 criteria for a current anxiety disorder: generalized anxiety disorder, post-traumatic stress disorder or social anxiety disorder as diagnosed by the Structured Clinical Interview for DSM-5.

Locations
United States
Virginia
Fralin Biomedical Research Institute at VTC
RECRUITING
Roanoke
Contact Information
Primary
Jessica Florig, MPH
jnw@vtc.vt.edu
540-526-2261
Time Frame
Start Date: 2024-12-04
Estimated Completion Date: 2026-10
Participants
Target number of participants: 25
Treatments
Experimental: Pain, Craving, and Anxiety measures
Multi visit - LIFU/Sham. Participants will complete pain, craving, and anxiety measures pre and post intervention.
Related Therapeutic Areas
Sponsors
Collaborators: Washington DC VA Medical Center, Salem VA Medical Center
Leads: Virginia Polytechnic Institute and State University

This content was sourced from clinicaltrials.gov