Low Intensity Focused Ultrasound for Chronic Pain
(LIFU_Pain Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have a psychiatric disorder, you must be on a stable medication regimen for at least 4 weeks before joining the trial.
What data supports the effectiveness of the treatment Low Intensity Focused Ultrasound for chronic pain?
Research shows that Low Intensity Focused Ultrasound (LIFU) can help manage chronic pain by affecting nerve activity, as seen in studies with animal models. It has shown promise in reducing pain from nerve injuries and soft tissue injuries, suggesting it might be effective for chronic pain in humans too.12345
How is Low Intensity Focused Ultrasound treatment different from other treatments for chronic pain?
Low Intensity Focused Ultrasound (LIFU) is unique because it is a noninvasive treatment that uses sound waves to target specific areas of the body, potentially altering nerve activity to relieve pain without the need for surgery or drugs. Unlike traditional pain medications, which may not be effective for everyone, LIFU offers a novel approach by modulating nerve signals and has shown promise in treating various types of chronic pain.13456
What is the purpose of this trial?
In this study, the research team will use low-intensity focused ultrasound (LIFU) to temporarily change brain activity in a brain region that is known to be involved in chronic pain. Through this, the research team hopes to learn about how the brain area works in response to pain. There are main questions this study aims to answer:* The effect of LIFU to inhibit the posterior region of the insula (PI) compared to sham stimulation in individuals with chronic back pain (CBP) and widespread pain symptoms.* The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of the Neurologic Pain Signature (NPS) in response to evoked thermal pain.* The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of Tonic Pain Signature in response to tonic pain.
Research Team
Mary R Lee, MD
Principal Investigator
Washington D.C. Veterans Affairs Medical Center
Eligibility Criteria
This trial is for individuals experiencing chronic back pain. Participants should have a history of pain that persists beyond the usual course of an acute illness or injury. Specific details about inclusion and exclusion criteria are not provided, but typically these would cover health status, age range, and other factors relevant to the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo low-intensity focused ultrasound (LIFU) or sham stimulation to study its effects on chronic pain and central sensitization processes.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including measures of central sensitization and pain signatures.
Crossover
Participants switch from LIFU to sham or vice versa to compare effects.
Treatment Details
Interventions
- Low Intensity Focused Ultrasound
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington D.C. Veterans Affairs Medical Center
Lead Sponsor