Recruiting

Low-Intensity Focused Ultrasound

Sponsor:

Carilion Clinic

Code:

NCT05751096

Conditions

Fibromyalgia

Complex Regional Pain Syndromes

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Low-intensity Focused Ultrasound (LIFU)

Sham Low-intensity focused ultrasound (LIFU)

Study Details

Brief summary:

Study investigating the potential benefit for chronic pain patients (CRPS and FM) using low-intensity focused ultrasound for neuromodulation.

Conditions

Fibromyalgia

Complex Regional Pain Syndromes

Chronic Pain

Study ID

NCT05751096

Start date

Jul 15, 2023

Status verified date

Oct, 2023

Completion date

Jan, 2025

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of complex regional pain syndrome (CRPS) I or II (Budapest Criteria) by Carilion physician. OR Diagnosis of fibromyalgia (FM) by Carilion physician (American College of Radiology 2011 modified fibromyalgia criteria).

Exclusion Criteria:

  • Contraindications to MRI.
  • Contraindications to CT
  • History of seizures and/or pseudo-seizures

Study Design

Enrollment

27 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: LIFU - CRPS

Real LIFU application for CRPS cohort.

sham comparator: SHAM - CRPS

Sham LIFU application for CRPS cohort.

active comparator: LIFU - FM

Real LIFU application for FM cohort.

sham comparator: SHAM - FM

Sham LIFU application for FM cohort.

Interventions

Low-intensity Focused Ultrasound (LIFU)

repeat pulse application of low intensity focused ultrasound using a single element transducer to a selected neurological target for neuromodulation.

Sham Low-intensity focused ultrasound (LIFU)

Sham application of LIFU.

Primary outcome measure

  • Perceived Pain scores [ Time Frame: through study completion, an average of 2 weeks. ]

Central Contacts and Locations

Central contacts

Jessica Florig, MPH

540-526-2261jnw@vtc.vt.edu

Locations

Fralin Biomedical Research Institute

Recruiting

Roanoke, Virginia, United States, 24016

Contacts

Jessica Florig, MPH

540-526-2261jnw@vtc.vt.edu

Principal Investigator:

Elizabeth Stringer, MD

More Information

Sponsor

Carilion Clinic

Last update posted

Oct 16, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carilion Clinic on 2023-10-16.