Clinical trial NCT06297200: Low-Intensity Focused Ultrasound and the Complex Patient
Official title: Investigations of Low-Intensity Focused Ultrasound Towards Treatment for the Complex Patient
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Chronic Pain
Anxiety Disorder
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: Salem VA Medical Center
name: Washington DC VA Medical Center
First posted: 2024-03-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events via a neurological examination
timeFrame: Assessed per participant, over the course of participation - an average of 4 weeks
measure: Incidence of Treatment-Emergent Adverse Events via a side effects questionnaire
timeFrame: Assessed per participant, over the course of participation - an average of 4 weeks
measure: Changes in Heart Rate (HR)
timeFrame: Assessed per participant, over the course of participation - an average of 4 weeks
measure: Changes in Respiration Rate (RR)
timeFrame: Assessed per participant, over the course of participation - an average of 4 weeks
measure: Changes in mood via visual analog mood scale (VAMS) such as the wong-baker face scale.
timeFrame: Assessed per participant, over the course of participation - an average of 4 weeks
measure: Changes in Blood Pressure (BP)
timeFrame: Assessed per participant, over the course of participation - an average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute at VTC
state: Virginia
Study officials:
References: