Investigations of Low-Intensity Focused Ultrasound Towards Treatment for the Complex Patient
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events via a neurological examination
Overview
Brief Summary
Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Masking Description
Sham trials will be utilized within subject. All subjects will receive sham and ultrasound conditions.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 ≥
- •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-
- •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.
Exclusion Criteria
- •Evidence of neuropathic pain
- •Previous spine surgery
- •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
- •Daily opiate use other than buprenorphine/methadone for OUD/pain control
- •Pregnant or breastfeeding
- •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
- •Ferromagnetic implants or other contraindications for magnetic resonance imaging (MRI)
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events via a neurological examination
Time Frame: 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.
Incidence of Treatment-Emergent Adverse Events via a side effects questionnaire
Time Frame: 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 Heart Rate (HR)
Time Frame: Assessed per participant, over the course of participation - an average of 4 weeks
changes in HR compared pre/post LIFU and at follow up
Changes in Respiration Rate (RR)
Time Frame: 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.
Time Frame: 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)
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Wynn Legon
Assistant Professor
Virginia Polytechnic Institute and State University