LIFU for Chronic Pain

Overseen By Jessica Florig, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Carilion Clinic

Disqualifiers: Seizures, Pseudo-seizures, MRI contraindications, others

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

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

27 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new therapy called low-intensity focused ultrasound (LIFU) for people with chronic pain conditions like CRPS and FM. LIFU uses gentle sound waves to target specific brain areas to help reduce pain. The study aims to see if this therapy can lower pain levels and improve other symptoms in these patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for chronic pain?

Research shows that low-intensity focused ultrasound (LIFU) can help reduce pain by affecting nerve activity, as seen in studies with animals experiencing nerve injuries and soft tissue injuries. This treatment is promising for managing chronic pain, as it has been approved for certain types of pain and is being explored for others. ^{1 2 3 4 5}

Is Low-intensity Focused Ultrasound (LIFU) safe for humans?

Research in animals like rodents and swine suggests that Low-intensity Focused Ultrasound (LIFU) can be used safely without causing harmful heating effects, but specific human safety data is not provided in the available studies. ^{1 2 3 5 6}

How is the treatment Low-intensity Focused Ultrasound (LIFU) unique for chronic pain?

Low-intensity Focused Ultrasound (LIFU) is unique for chronic pain because it is a non-invasive treatment that uses sound waves to target specific areas of the nervous system, potentially reducing pain without the need for medication. Unlike traditional pain treatments, LIFU can modulate pain responses by affecting neuronal activity in pain-processing regions, offering a novel approach with minimal side effects. ^{1 2 5 7 8}

Research Team

Elizabeth Stringer, MD

Principal Investigator

Carilion Clinic

Eligibility Criteria

This trial is for individuals with chronic pain conditions, specifically diagnosed with fibromyalgia or complex regional pain syndrome by a Carilion physician. Participants must meet certain diagnostic criteria and cannot have contraindications to MRI or CT scans, nor a history of seizures.

Inclusion Criteria

I have been diagnosed with fibromyalgia by a Carilion physician.

I have been diagnosed with CRPS type I or II by a Carilion doctor.

Exclusion Criteria

I have a history of seizures.

You are not able to have an MRI for medical reasons.

I cannot undergo CT scans due to health reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

MRI and CT anatomical scans are obtained, and baseline clinical measurements of the target limb are recorded

1 session

1 visit (in-person)

Treatment

Participants undergo LIFU or sham treatment with QST and clinical measurements

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in perceived pain, skin temperature, and swelling circumference

2 weeks

Treatment Details

Interventions

• Low-intensity Focused Ultrasound (LIFU)
• Sham Low-intensity focused ultrasound (LIFU)

Trial Overview The study is testing the effectiveness of Low-intensity Focused Ultrasound (LIFU) as a neuromodulation treatment for chronic pain. Some participants will receive real LIFU while others will get a sham procedure to compare outcomes.

Participant Groups

Group I: LIFU - CRPS Active Control 1 Intervention

Real LIFU application for CRPS cohort.

Group II: LIFU - FM Active Control 1 Intervention

Real LIFU application for FM cohort.

Group III: SHAM - CRPS Placebo Group 1 Intervention

Sham LIFU application for CRPS cohort.

Group IV: SHAM - FM Placebo Group 1 Intervention

Sham LIFU application for FM cohort.

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials

85

Recruited

15,400+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+

Findings from Research

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]

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]

Low intensity focused ultrasound (liFUS) can modulate pain responses without causing significant heating, as demonstrated in swine models, with magnetic resonance thermometry imaging (MRTI) effectively measuring temperature changes of less than 2.0 °C at the L5 dorsal root ganglion (DRG).

The study identified that referenceless MRTI is capable of accurately detecting small thermal changes, which is crucial for establishing safe parameters for future liFUS therapy in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR thermometry imaging for low intensity focused ultrasound modulation of spinal nervous tissue. Olinger, C., Vest, J., Tarasek, M., et al.[2023]

High-density gel polymer matrices are effective couplants for low-intensity focused ultrasound (LIFU) neuromodulation, showing low acoustic attenuation (3.3%) and minimal beam distortion, making them suitable for clinical use.

The study highlights the importance of using standardized methods for preparing these gels to ensure consistent performance, as factors like thickness and de-gassing can significantly affect acoustic transmission and pressure attenuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Novel Acoustic Coupling Medium for Human Low-Intensity Focused Ultrasound Neuromodulation Applications. Strohman, A., In, A., Stebbins, K., et al.[2023]

Low-intensity focused ultrasound (LIFU) therapy significantly reduced cancer-related neuropathic pain in a retrospective study of 22 patients, with a p-value of less than 0.001 indicating strong statistical significance.

Approximately 76.5% of patients responded positively to LIFU therapy, suggesting it may be an effective treatment option for neuropathic pain, particularly that caused by chemotherapy, and it has a minimal side effect profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary effects of low-intensity focused ultrasound treatment program for cancer-related neuropathic pain. Patel, AA., Zhukosvky, M., Sidharthan, S., et al.[2022]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

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

3. 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]

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

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

MR thermometry imaging for low intensity focused ultrasound modulation of spinal nervous tissue. [2023]

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

Improved outcomes with advancements in high intensity focused ultrasound devices for the treatment of localized prostate cancer. [2014]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of a Novel Acoustic Coupling Medium for Human Low-Intensity Focused Ultrasound Neuromodulation Applications. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Preliminary effects of low-intensity focused ultrasound treatment program for cancer-related neuropathic pain. [2022]