Low-Intensity Focused Ultrasound and the Complex Patient

Virginia Polytechnic Institute and State University

Status: Not yet enrolling

Conditions: Anxiety Disorder; Opioid Use Disorder; Chronic Pain

Treatments: Device: Low-Intensity Focused Ultrasound - sham; Device: Low-Intensity Focused Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06297200

24-050

Details and patient eligibility

About

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

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females aged 18-65 years
2. 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.
3. 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.
4. 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.
5. Be in treatment for opioid use disorder (OUD) including buprenorphine or methadone.
6. 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.

Exclusion criteria

1. Evidence of neuropathic pain
2. Previous spine surgery
3. Current substance use disorder other than OUD or tobacco use disorder
4. Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
5. Chronic Pain Conditions other than chronic back pain
6. Daily opiate use other than buprenorphine/methadone for OUD/pain control
7. Pregnant or breastfeeding
8. History of head injury, seizures, neurologic disorders including cerebrovascular disease, stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases
9. 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
10. Ferromagnetic implants or other contraindications for magnetic resonance imaging (MRI)
11. 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
12. Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active system infection end stage renal disease

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Pain, Craving, and Anxiety measures

Experimental group

Description:

Multi visit - LIFU/Sham. Participants will complete pain, craving, and anxiety measures pre and post intervention.

Treatment:

Device: Low-Intensity Focused Ultrasound - sham

Device: Low-Intensity Focused Ultrasound