Low Intensity Focused Ultrasound for Chronic Pain

(LIFU_Pain Trial)

Recruiting at 1 trial location

Overseen By Evan Evan Lindeman, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington D.C. Veterans Affairs Medical Center

Must not be taking: Opiates

Disqualifiers: Fibromyalgia, Substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 session

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new technique, low-intensity focused ultrasound (LIFU), can alter brain activity to reduce chronic pain. Researchers aim to determine if LIFU can effectively decrease pain by targeting a specific brain area linked to pain processing. Participants will receive either the actual LIFU treatment or a sham (inactive) treatment for comparison. The study seeks veterans who have experienced chronic back pain daily for the past 3 months or most days for the past 6 months and who also have pain in another body part. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new pain management solutions.

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 prior data suggests that this low-intensity focused ultrasound is safe for chronic pain?

Research has shown that low-intensity focused ultrasound (LIFU) can be safely and effectively used in the brain. One study found that LIFU can target specific brain areas without causing harm, and it has been well-tolerated in similar regions. Another study examined the posterior insula, a brain part involved in processing pain, and found that LIFU could lower pain levels during certain tests. This indicates that LIFU can alter brain activity related to pain without major safety concerns.

Overall, LIFU has been used in both humans and animals as a non-invasive tool (meaning it doesn't require surgery) to manage pain. It can precisely target pain areas in the brain without significant risks. So far, no major side effects have been reported, making it a promising option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Low Intensity Focused Ultrasound (LIFU) for chronic pain because it offers a non-invasive alternative to standard treatments like medications and physical therapy. Unlike many pain relief options that rely on drugs, LIFU uses sound waves to target and potentially reduce pain at its source, minimizing the risk of side effects associated with long-term medication use. This innovative approach could provide a new way to manage pain more effectively and comfortably for patients who suffer from chronic back pain.

What evidence suggests that low-intensity focused ultrasound is effective for chronic pain?

Research shows that low-intensity focused ultrasound (LIFU) can reduce pain by targeting the brain. Studies have found that applying LIFU to the posterior insula, a brain area involved in processing pain, lowers pain levels in certain tests. In healthy individuals, LIFU reduced pain sensations when pain was intentionally induced. This trial will compare LIFU with a sham treatment in a double-blind, crossover study to further explore its potential for managing chronic pain. Although more research is needed, these findings offer hope for chronic pain management. ^{1 2 3 4 5}

Who Is on the Research Team?

Mary R Lee, MD

Principal Investigator

Washington D.C. Veterans Affairs Medical Center

Are You a Good Fit for This Trial?

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

I experience widespread pain, including in my limbs, but in fewer than 11 places.

CBP duration daily for last 3 months or half of days for last 6 months

My pain level is at least 4 out of 10.

Exclusion Criteria

I have had a serious head injury, seizures, stroke, brain surgery, a brain tumor, or multiple sclerosis.

My doctor recommends surgery as the first treatment for my condition.

I have been diagnosed with fibromyalgia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo low-intensity focused ultrasound (LIFU) or sham stimulation to study its effects on chronic pain and central sensitization processes.

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measures of central sensitization and pain signatures.

1 hour post-treatment

Crossover

Participants switch from LIFU to sham or vice versa to compare effects.

1 session

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Low Intensity Focused Ultrasound

Trial Overview The trial is testing low-intensity focused ultrasound (LIFU) on a brain region called the posterior insula (PI), which is involved in processing chronic pain. The goal is to see if LIFU can reduce pain intensity compared to sham (fake) stimulation using measures like the Neurologic Pain Signature for thermal pain and Tonic Pain Signature for ongoing pain.

How Is the Trial Designed?

Group I: Sham/LIFU Experimental Treatment 1 Intervention

double-blind, sham-controlled, crossover study in N=66 individuals with Chronic Back Pain

Group II: LIFU/Sham Experimental Treatment 1 Intervention

double-blind, sham-controlled, crossover study in N=66 individuals with Chronic Back Pain

Who Is Running the Clinical Trial?

Washington D.C. Veterans Affairs Medical Center

Lead Sponsor

Trials

45

Recruited

18,500+

Published Research Related to This Trial

Focused ultrasound (FUS) is a promising noninvasive technique for managing chronic pain, with approved uses for thalamotomy in neuropathic pain and treatment of pain from bone metastases.

Different intensities of FUS can produce varying effects: low-intensity ultrasound (LILFUS) can facilitate or suppress neural activity, while high-intensity focused ultrasound (HIFU) can ablate tissue, showing potential for treating conditions like knee osteoarthritis and refractory chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focused Ultrasound (FUS) for Chronic Pain Management: Approved and Potential Applications. di Biase, L., Falato, E., Caminiti, ML., et al.[2021]

In a study involving 30 male Sprague Dawley rats with common peroneal nerve injury, low intensity focused ultrasound (liFUS) applied to the L5 dorsal root ganglion significantly altered neuronal activity, increasing pyramidal neuron spike frequency in the primary somatosensory cortex (SI) and reducing interneuron firing in the anterior cingulate cortex (ACC).

These changes in neuronal activity occurred 80 to 120 minutes after liFUS treatment and may correlate with improved sensory thresholds, suggesting a potential mechanism for how liFUS can help alleviate neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of low intensity focused ultrasound on neuronal activity in pain processing regions in a rodent model of common peroneal nerve injury. Bao, J., Byraju, K., Patel, VJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12209223/

Low-intensity focused ultrasound of the spine in the treatment ... In this work, we review current advances in LIFU of the spine region for the treatment of chronic neuropathic pain and movement disorders.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06906211

Low Intensity Focused Ultrasound for Chronic Pain: High ... The preliminary data indicate that LIFU to PI reduces laboratory measures of central sensitization and evoked pain in healthy controls but there was no such ...

3. fusfoundation.org fusfoundation.org/posts/low-back-pain-clinical-data-show-focused-ultrasound-is-safe-and-effective/

Low Back Pain: Clinical Data Show Focused Ultrasound is ... FUSMobile recently published positive clinical trial results using high-intensity focused ultrasound (HIFU) to treat low back pain.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X24001359

Low-intensity focused ultrasound to the posterior insula ... LIFU to the posterior insula reduced pain ratings during temporal summation of pain but not conditioned pain modulation.

5. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-025-02096-y

The efficacy and mechanisms of low-intensity transcranial ... The efficacy and mechanisms of low-intensity transcranial ultrasound stimulation on pain: a systematic review of human and animal studies. Hao- ...