Low Intensity Focused Ultrasound for Chronic Pain

(LIFU_Pain Trial)

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

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. ^{1 2 3 4 5}

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. ^{1 3 4 5 6}

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Focused Ultrasound (FUS) for Chronic Pain Management: Approved and Potential Applications. [2021]

2. Croatia pubmed.ncbi.nlm.nih.gov

[Therapeutic ultrasound in chronic low back pain treatment]. [2009]

3. Ireland 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Low Intensity Focused Ultrasound Increases Duration of Anti-Nociceptive Responses in Female Common Peroneal Nerve Injury Rats. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Alleviation Effects and Mechanisms of Low-intensity Focused Ultrasound on Pain Triggered by Soft Tissue Injury. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Focused Ultrasound for Chronic Pain. [2022]