Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula

Launched by WASHINGTON D.C. VETERANS AFFAIRS MEDICAL CENTER · Mar 25, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for people with chronic back pain using a technique called low-intensity focused ultrasound (LIFU). This method uses sound waves to temporarily change the activity in a specific part of the brain that is linked to pain. The researchers want to find out if LIFU can help reduce pain and how the brain responds to different types of pain. They will compare the effects of LIFU with a "sham" treatment (which is like a placebo) to see if there are any real benefits.

To be eligible for this study, participants need to be veterans aged between 21 and 75 who have been experiencing chronic back pain for at least three months. They should also have a pain rating of 4 out of 10 or higher and some pain in other parts of the body. However, certain conditions would exclude someone from participating, such as if they have had surgery recommended for their pain, have a diagnosis of fibromyalgia, or are currently pregnant. If you join the trial, you can expect to receive either the LIFU treatment or a sham treatment and help researchers learn more about how to effectively manage chronic pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Veterans aged 21 to 75 with Chronic Back Pain (CBP).
• • CBP duration daily for last 3 months or half of days for last 6 months
• • Endorse pain rating of 4/10 BPI-SF
• • Evidence of widespread pain symptoms as determined by report of CBP and pain in a contralateral limb (pain in the upper, lower, left or right side of the body) in fewer than 11 sites. Upper body sites include hand, wrist, elbow or shoulder. Lower sites include hip, knee, ankle or foot.
• Exclusion Criteria:
• • Surgery recommended as primary treatment intervention for CBP
• • Current diagnosis of fibromyalgia
• • Current substance use disorder other than nicotine.
• • Psychiatric disorder and not on a stable pharmacologic regimen for ≥ 4 weeks prior to screening
• • Opiate use daily
• • Currently pregnant or breast feeding.
• • Unable to understand the consent form.
• • History of head injury with loss of consciousness for more than 5 minutes, seizures, history of stroke, brain surgery, brain tumor, multiple sclerosis.
• • History of metastatic cancer, rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus, or polymyositis
• • Unintended weight loss of 20 pounds or more in the last year
• • Cauda equina syndrome
• • Ferromagnetic implants or other contraindications for MRI
• • Uncompensated congestive heart failure, unstable angina, poorly controlled arrhythmia, active systemic infection end stage renal disease.