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WithdrawnNo phase
Low-Intensity Focused Ultrasound and the Complex Patient
Key facts
- Who runs it
- Virginia Polytechnic Institute and State University
- Where
- Roanoke, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Started
- 4 Dec 2024
- Ended
- 31 Oct 2026
- Type of study
- Interventional
- Treatments tested
- Low-Intensity Focused Ultrasound
- Low-Intensity Focused Ultrasound - sham
- Record updated
- 9 November 2026
- Why it stopped
- Unable to recruit any eligible participants.
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous spine surgery
- Ferromagnetic implants or other contraindications for magnetic resonance imaging (MRI)
- Current substance use disorder other than OUD or tobacco use disorder
- Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
- Chronic Pain Conditions other than chronic back pain
- History of head injury, seizures, neurologic disorders including cerebrovascular disease, stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases
- History of metastasizing cancers, inflammatory disorder (rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus or polymyositis), unintended weight loss of 20 pounds or more in the last year, or cauda equina syndrome
- Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active system infection end stage renal disease
- Evidence of arteriovenous malformation, aneurysm, infarct, meningioma, parenchymal brain tumor or evidence of neurodegenerative processes and/or white matter lesions greater than that expected for age as determined by the study neuroradiologist
- Evidence of neuropathic pain
- Daily opiate use other than buprenorphine/methadone for OUD/pain control
- Pregnant or breastfeeding
Where in United States
- Fralin Biomedical Research Institute at VTCRoanoke, United States
About the trial
What the trial wants to find out
Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.
The group in the trial
- Pain, Craving, and Anxiety measuresTreatment being tested
Multi visit - LIFU/Sham. Participants will complete pain, craving, and anxiety measures pre and post intervention.
Treatment: Low-Intensity Focused Ultrasound and Low-Intensity Focused Ultrasound - sham
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Investigations of Low-Intensity Focused Ultrasound Towards Treatment for the Complex Patient
- Record updated
- 9 November 2026