Clinical trial for Chronic Back Pain
Official title Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula
ClinicalTrials.gov ID: NCT06906211
What this study is testing
- What it's testing
- The study wants to learn whether targeting a specific brain area with ultrasound can change how pain is felt and measured in people with chronic back pain.
- Who it's for
- Adults who have chronic back pain and also experience widespread pain symptoms.
- What's involved
- Participants will receive either the ultrasound treatment or a sham (placebo) procedure, and will undergo pain tests and brain scans to measure changes.
- Time commitment
- The study lasts several weeks, with multiple visits for treatment, pain testing, and brain imaging sessions.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 75
You may be able to join if
- Veterans aged 21 to 75 with Chronic Back Pain (CBP).
- CBP duration daily for last 3 months or half of days for last 6 months
- Endorse pain rating of 4/10 BPI-SF
- Evidence of widespread pain symptoms as determined by report of CBP and pain in a contralateral limb (pain in the upper, lower, left or right side of...
You likely can't join if
- Surgery recommended as primary treatment intervention for CBP
- Current diagnosis of fibromyalgia
- Current substance use disorder other than nicotine.
- Psychiatric disorder and not on a stable pharmacologic regimen for ≥ 4 weeks prior to screening
- Opiate use daily
- Currently pregnant or breast feeding.
See the full eligibility criteria
- Veterans aged 21 to 75 with Chronic Back Pain (CBP).
- CBP duration daily for last 3 months or half of days for last 6 months
- Endorse pain rating of 4/10 BPI-SF
- Evidence of widespread pain symptoms as determined by report of CBP and pain in a contralateral limb (pain in the upper, lower, left or right side of the body) in fewer than 11 sites.
- Surgery recommended as primary treatment intervention for CBP
- Current diagnosis of fibromyalgia
- Current substance use disorder other than nicotine.
- Psychiatric disorder and not on a stable pharmacologic regimen for ≥ 4 weeks prior to screening
- Opiate use daily
- Currently pregnant or breast feeding.
- Unable to understand the consent form.
- History of head injury with loss of consciousness for more than 5 minutes, seizures, history of stroke, brain surgery, brain tumor, multiple sclerosis.
- History of metastatic cancer, rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus, or polymyositis
- Unintended weight loss of 20 pounds or more in the last year
- Cauda equina syndrome
- Ferromagnetic implants or other contraindications for MRI
- Uncompensated congestive heart failure, unstable angina, poorly controlled arrhythmia, active systemic infection end stage renal disease.
The study team makes the final eligibility decision.
Where it is enrolling
- Washington D.C., District of Columbia, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Washington D.C., District of Columbia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.