Sign in
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Withdrawn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