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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 weeks

Awards & highlights

Study Summary

This trial looks at using sound waves to reduce pain in chronic pain sufferers.

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.Check my eligibility

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.See study design

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

Select...

I have been diagnosed with fibromyalgia by a Carilion physician.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Perceived Pain scores

Secondary outcome measures

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Carilion ClinicLead Sponsor

72 Previous Clinical Trials

12,735 Total Patients Enrolled

Virginia Polytechnic Institute and State UniversityOTHER

143 Previous Clinical Trials

27,786 Total Patients Enrolled

Elizabeth Stringer, MDPrincipal InvestigatorCarilion Clinic

1 Previous Clinical Trials

80 Total Patients Enrolled

Media Library

Low-intensity Focused Ultrasound (LIFU) (Ultrasound Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05751096 — N/A

Fibromyalgia Research Study Groups: LIFU - CRPS, SHAM - CRPS, LIFU - FM, SHAM - FM

Fibromyalgia Clinical Trial 2023: Low-intensity Focused Ultrasound (LIFU) Highlights & Side Effects. Trial Name: NCT05751096 — N/A

Low-intensity Focused Ultrasound (LIFU) (Ultrasound Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05751096 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors being accepted into this clinical trial?

"The requisite age range for this trial is 18 to 65 years old."

Answered by AI

Could I be eligible to partake in this investigative project?

"In order to qualify for this trial, applicants must have a diagnosis of fibromyalgia and be within the age brackets of 18-65. The project is seeking 27 total participants."

Answered by AI

Are any fresh participants being incorporated into the research?

"According to the clinicaltrials.gov data, this medical study is not currently recruiting patients for participation. This trial's initial posting was on March 1st 2023 and its last update occurred in February of the same year. Nevertheless, 494 other research projects are presently accepting enrolment applications from prospective participants."

Answered by AI

Who else is applying?

What site did they apply to?

Fralin Biomedical Research Institute

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

What questions have other patients asked about this trial?

How Long will screening take? Will travel be provided?

PatientReceived 2+ prior treatments

Why did patients apply to this trial?

To try and get help for crps pain and maybe help find a treatment for others with this disease.

PatientReceived no prior treatments

I have been dealing with chronic pain caused by both my Fibromyalgia and CRPS-2 for almost 3 years now, and any relief I can get I welcome.

PatientReceived 2+ prior treatments

I am currently prescribed pain medication for all my pain from Dr. Mochel. I have been unable to find and get treated by a specialist. What I am taking is not anywhere near what I have been on and is not working for me very much. Also, I've had great difficulty with any medical professionals here that are willing or even the knowledge to treat me properly.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

Low-Intensity Focused Ultrasound For Insular Neuromodulation in Chronic Pain

2023. "Low-Intensity Focused Ultrasound For Insular Neuromodulation in Chronic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05751096.

All > Complex Regional Pain Syndrome > Fibromyalgia