Using low-intensity focused ultrasound to treat chronic pain
Low-Intensity Focused Ultrasound For Insular Neuromodulation in Chronic Pain
NA · Carilion Clinic · NCT05751096
This study is testing whether low-intensity focused ultrasound can help people with chronic pain from conditions like complex regional pain syndrome and fibromyalgia feel less pain and improve their symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Carilion Clinic (other) |
| Locations | 1 site (Roanoke, Virginia) |
| Trial ID | NCT05751096 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of low-intensity focused ultrasound (LIFU) on patients with chronic pain conditions, specifically complex regional pain syndrome (CRPS) and fibromyalgia (FM). It aims to determine whether LIFU can reduce pain sensation and improve clinical outcomes such as skin temperature and swelling in the affected limbs. The study employs a randomized, counterbalanced design where participants will receive either active or sham LIFU treatment during separate visits. The primary focus is to assess the physiological responses elicited by LIFU in these populations.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with complex regional pain syndrome or fibromyalgia.
Not a fit: Patients with contraindications to MRI or CT, or those with a history of seizures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive treatment option for patients suffering from chronic pain.
How similar studies have performed: While LIFU has shown promise in healthy participants, this specific application for chronic pain is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Roanoke, Virginia
- Fralin Biomedical Research Institute — Roanoke, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Elizabeth Stringer, MD — Carilion Clinic
- Study coordinator: Jessica Florig, MPH
- Email: jnw@vtc.vt.edu
- Phone: 540-526-2261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibromyalgia, Complex Regional Pain Syndromes, Chronic Pain