LIFU for Chronic Pain

Overseen By Wynn Assistant Professor, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Disqualifiers: Claustrophobia, Neurologic disorder, Alcohol dependence, others

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

Compensation: Varies

Number of Visits: 9

80 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an active medical disorder or treatment that affects the central nervous system, you may be excluded from participating.

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

There is limited evidence that acupuncture, a treatment somewhat similar to LIFU, is more effective than no treatment for chronic pain, with some studies showing positive outcomes after multiple sessions. ^{1 2 3 4 5}

How does LIFU treatment for chronic pain differ from other treatments?

LIFU (Low-Intensity Focused Ultrasound) is unique because it uses sound waves to target and relieve chronic pain, unlike traditional treatments like acupuncture or electroacupuncture, which involve needles and electrical stimulation. This non-invasive approach may offer a novel mechanism for pain relief without the need for medication or physical insertion into the body. ^{1 6 7 8 9}

What is the purpose of this trial?

This research project is examining the effects of noninvasive brain stimulation on chronic pain. We believe this study will help us to better understand possible treatments for chronic pain patients. Subjects will undergo functional magnetic resonance imaging (fMRI) and a computed tomography (CT) scan, which is a way to take pictures of the brain and skull. Subjects will receive noninvasive brain stimulation using low-intensity focused ultrasound (LIFU) sound waves, to temporarily change brain activity. Subjects will undergo pain testing using a small device that will increase the temperature of their skin and will rate this pain. Brain signals (EEG), heart rate and rhythm, blood pressure, respiration rate, and skin moisture will be monitored. Subjects will complete behavioral questionnaires. Each study session is expected to take 1.5-3 hours. Total participation takes 10 weeks.

Eligibility Criteria

This trial is for individuals who have been experiencing moderate-to-severe chronic pain for at least three months. Participants must understand and speak English, but people of all ethnicities are welcome.

Inclusion Criteria

I have had moderate-to-severe chronic pain for at least 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Imaging

Participants undergo MRI and CT scans, complete questionnaires, and undergo QST testing

1 visit

1 visit (in-person)

Intervention

Participants receive sham or verum LIFU application with quantitative sensory testing and physiological data collection

1 visit

1 visit (in-person)

Follow-Up Imaging

Participants receive resting-state MRI scans following intervention sessions

4 weeks

Up to 4 visits (in-person)

Follow-Up Virtual Questionnaires

Participants complete virtual questionnaires to rate pain and report lifestyle impacts

2 weeks

At least 2 times per week

Second Intervention and Follow-Up

Participants undergo a second intervention visit after a minimum 4-week washout period, followed by a 3-week follow-up period

3 weeks

1 visit (in-person) for intervention, follow-up virtual questionnaires

Treatment Details

Interventions

• LIFU

Trial Overview The study is testing the effects of low-intensity focused ultrasound (LIFU) on chronic pain by comparing it with a sham procedure. It involves brain scans, temperature-induced pain tests, monitoring vital signs, and completing questionnaires over ten weeks.

Participant Groups

Group I: Verum LIFU Experimental Treatment 1 Intervention

Active LIFU application with 3 week follow-up (MRI, questionnaires)

Group II: Sham LIFU Placebo Group 1 Intervention

Sham application of LIFU - all follow up (MRI, questionnaires) will be identical.

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Focused Ultrasound Foundation

Collaborator

Trials

18

Recruited

460+

Findings from Research

Internal qigong significantly reduced chronic pain compared to control groups, with a notable effect size of -1.23, indicating its potential as an effective treatment option.

External qigong showed some benefits but did not consistently outperform control or waiting list groups, suggesting that more rigorous studies are needed to confirm its efficacy in chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Qigong for Adults with Chronic Pain: Systematic Review and Meta-Analysis. Bai, Z., Guan, Z., Fan, Y., et al.[2022]

In a pilot study involving 22 patients with chronic neuropathic pain, electroacupuncture (EA) significantly reduced pain intensity by 46.7% after 4 weeks of treatment, indicating its potential effectiveness as an add-on therapy.

Patients reported improvements in specific pain types, such as burning and electric shock-like pain, along with enhanced psychosocial well-being, suggesting that EA not only alleviates pain but also improves quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroacupuncture May Improve Burning and Electric Shock-Like Neuropathic Pain: A Prospective Exploratory Pilot Study. Lee, S., Lee, CS., Moon, JY., et al.[2021]

References

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

Incidence of prolonged pain relief following acupuncture. [2019]

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

Low-level laser therapy for chronic non-specific low back pain: a meta-analysis of randomised controlled trials. [2022]

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

Is acupuncture effective for the treatment of chronic pain? A systematic review. [2022]

4. Scotland pubmed.ncbi.nlm.nih.gov

Acupuncturists' perspectives on outcome measures to evaluate acupuncture care for chronic low back pain. [2015]

5. Singapore pubmed.ncbi.nlm.nih.gov

The Effects of Qigong for Adults with Chronic Pain: Systematic Review and Meta-Analysis. [2022]

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

Acupuncture for chronic pain in Japan: a review. [2021]

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

Electroacupuncture May Improve Burning and Electric Shock-Like Neuropathic Pain: A Prospective Exploratory Pilot Study. [2021]

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

The H-Wave device is an effective and safe non-pharmacological analgesic for chronic pain: a meta-analysis. [2011]

9. China pubmed.ncbi.nlm.nih.gov

[Effects of electroacupuncture on activation of microglia cells in spinal cord in rats with neuropathic pain]. [2018]