Using low-intensity focused ultrasound to treat complex patients with pain and anxiety

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

This study is testing whether low-intensity focused ultrasound can help people with chronic back pain, anxiety, and opioid use disorder feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Virginia Polytechnic Institute and State University (Academic / other)
• Locations: 1 site (Roanoke, Virginia)
• Trial ID: NCT06297200 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of Low-Intensity Focused Ultrasound (LIFU) on patients suffering from chronic back pain, opioid use disorder, and anxiety disorders. Participants will receive either active LIFU treatment or a sham procedure to assess changes in pain levels, cravings for opioids, and anxiety symptoms. The study aims to determine the efficacy of LIFU as a non-invasive treatment option for this complex patient population. The research will involve a thorough evaluation of participants' conditions using established diagnostic criteria.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 18-65 with chronic back pain, opioid use disorder, and a current anxiety disorder.

Not a fit: Patients with neuropathic pain or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel, non-invasive option for managing pain and anxiety in patients with opioid use disorder.

How similar studies have performed: While the use of focused ultrasound is gaining interest, this specific application in complex patients with opioid use disorder and anxiety is relatively novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Roanoke, Virginia

• Fralin Biomedical Research Institute at VTC — Roanoke, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Jessica Florig, MPH

Conditions Opioid Use Disorder; Chronic Pain; Anxiety Disorder