What side effects are associated with this type of intervention?

Common treatments for fibromyalgia include medications such as antidepressants, anticonvulsants, and pain relievers, as well as nonpharmacologic therapies like cognitive behavioral therapy (CBT), exercise, and neuromodulation techniques. Known side effects of these treatments can vary: antidepressants may cause nausea, weight gain, and fatigue; anticonvulsants can lead to dizziness, drowsiness, and swelling; and pain relievers might result in gastrointestinal issues. Neuromodulation techniques, such as transcranial magnetic stimulation (TMS) and noninvasive vagus nerve stimulation (nVNS), generally have mild side effects like tingling, redness, and muscle spasms, with no serious adverse events reported.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of fibromyalgia, including pregabalin (Lyrica), duloxetine (Cymbalta), and milnacipran (Savella). These medications primarily target pain and other symptoms through different mechanisms, such as modulating neurotransmitter levels. While neuromodulation techniques like Low-Intensity Focused Ultrasound are still under investigation, other neuromodulation devices, such as transcranial magnetic stimulation (TMS), have shown promise in clinical trials for migraine treatment, suggesting potential future applications for fibromyalgia.

What other types of research exist?

Promising novel alternatives to Low-Intensity Focused Ultrasound for fibromyalgia patients include: 1) High-Frequency Spinal Cord Stimulation (SCS), which has shown efficacy in reducing chronic pain without the sensation of paresthesia. 2) Mindfulness-Based Stress Reduction (MBSR) and Cognitive Behavioral Therapy (CBT), both of which have demonstrated benefits in managing chronic pain and improving quality of life. 3) Transcutaneous Electrical Nerve Stimulation (TENS), which has been effective in providing pain relief for chronic conditions. 4) Yoga and guided imagery, which have been shown to reduce pain and improve functional outcomes in chronic pain patients.

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Ultrasound Therapy

LIFU for Chronic Pain

N/A

Recruiting

Led By Elizabeth Stringer, MD

Research Sponsored by Carilion Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of fibromyalgia (FM) by Carilion physician (American College of Radiology 2011 modified fibromyalgia criteria)

Diagnosis of complex regional pain syndrome (CRPS) I or II (Budapest Criteria) by Carilion physician

Must not have

History of seizures and/or pseudo-seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive ultrasound technology, side effects are expected to be minimal but may include discomfort at the site of application or temporary changes in sensation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with fibromyalgia by a Carilion physician.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Perceived Pain scores

Secondary study objectives

Clinical outcome - skin temperature

Clinical outcomes - circumference

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: LIFU - CRPSActive Control1 Intervention

Real LIFU application for CRPS cohort.

Group II: LIFU - FMActive Control1 Intervention

Real LIFU application for FM cohort.

Group III: SHAM - CRPSPlacebo Group1 Intervention

Sham LIFU application for CRPS cohort.

Group IV: SHAM - FMPlacebo Group1 Intervention

Sham LIFU application for FM cohort.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for fibromyalgia, such as Low-Intensity Focused Ultrasound (LIFU), Transcutaneous Electrical Nerve Stimulation (TENS), Scrambler therapy, and acupuncture, primarily work through neuromodulation. These techniques aim to alter neural activity to reduce pain perception and improve other symptoms like fatigue and mood disturbances. For instance, LIFU targets specific brain regions to modulate pain pathways, while TENS and Scrambler therapy use electrical currents to interfere with pain signals. Acupuncture may stimulate nerve endings to release pain-relieving chemicals. Understanding these mechanisms is important for fibromyalgia patients as it provides insight into how these treatments can potentially alleviate their symptoms and improve their quality of life.

Alteration of cortical excitability in patients with fibromyalgia.