Low-Intensity Focused Ultrasound and the Complex Patient
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVirginia Polytechnic Institute and State University
About this trial
Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Evidence of neuropathic pain
Previous spine surgery
Current substance use disorder other than OUD or tobacco use disorder
Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
Trial design
Treatments tested in this trial
- Low-Intensity Focused Ultrasound
- Low-Intensity Focused Ultrasound - sham
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Virginia Polytechnic Institute and State University
Lead sponsor
Salem VA Medical Center
Collaborator
Washington DC VA Medical Center
Collaborator
Source ClinicalTrials.gov