Low-Intensity Focused Ultrasound and the Complex Patient

Not Applicable

Recruiting

• Conditions: Opioid Use Disorder; Chronic Pain; Anxiety Disorder
• Interventions: Device: Low-Intensity Focused Ultrasound; Device: Low-Intensity Focused Ultrasound - sham

• Registration Number: NCT06297200
• Lead Sponsor: Virginia Polytechnic Institute and State University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-07
• Study Start: 2024-12-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pain, Craving, and Anxiety measures	Low-Intensity Focused Ultrasound	Multi visit - LIFU/Sham. Participants will complete pain, craving, and anxiety measures pre and post intervention.
Pain, Craving, and Anxiety measures	Low-Intensity Focused Ultrasound - sham	Multi visit - LIFU/Sham. Participants will complete pain, craving, and anxiety measures pre and post intervention.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events via a neurological examination	Assessed per participant, over the course of participation - an average of 4 weeks	Any abnormal finding from the neurological exam will be recorded as an adverse event (AE) and tabulated with the side effects and tolerability data.
Changes in Heart Rate (HR)	Assessed per participant, over the course of participation - an average of 4 weeks	changes in HR compared pre/post LIFU and at follow up
Incidence of Treatment-Emergent Adverse Events via a side effects questionnaire	Assessed per participant, over the course of participation - an average of 4 weeks	Side effects and reported severity will be tabulated and summarized on a 5 point likert scale.
Changes in Respiration Rate (RR)	Assessed per participant, over the course of participation - an average of 4 weeks	changes in RR compared pre/post LIFU and at follow up
Changes in mood via visual analog mood scale (VAMS) such as the wong-baker face scale.	Assessed per participant, over the course of participation - an average of 4 weeks	changes in mood scale compared pre/post LIFU and at follow up
Changes in Blood Pressure (BP)	Assessed per participant, over the course of participation - an average of 4 weeks	changes in BP (systolic and diastolic) compared pre/post LIFU and at follow up

Trial Locations

Locations (1)

Fralin Biomedical Research Institute at VTC; 🇺🇸 Roanoke, Virginia, United States