LIFU for Chronic Pain

Recruiting in Palo Alto (17 mi)

Overseen ByElizabeth Stringer, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Carilion Clinic

No Placebo Group

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.

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.

Participant Groups

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.

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.