Using focused ultrasound to treat chronic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of low-intensity focused ultrasound (LIFU) to modulate brain activity in the insula, a region associated with chronic pain. The research aims to compare the effects of LIFU on pain intensity and neurological pain signatures in individuals suffering from chronic back pain. By targeting the posterior insula, the study seeks to provide insights into the brain's response to pain and evaluate the potential of LIFU as a non-addictive treatment option. Participants will undergo LIFU or sham stimulation to assess the efficacy of this approach in reducing pain symptoms.

Why it matters

Who can join: the full rules

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.

Where it's running

• Washington DC Veterans Affairs Medical Center
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Principal investigator: Mary R Lee, MD — Washington D.C. Veterans Affairs Medical Center
• Study coordinator: Mary R Lee, MD
• Email: mary.lee3@va.gov
• Phone: 202-745-8000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.