Low-Intensity Focused Ultrasound for Chronic Back Pain
This study is exploring a new way to help people with chronic back pain (CBP) using low-intensity focused ultrasound (LIFU). LIFU is a device that uses sound waves to temporarily change brain activity in a specific area linked to chronic pain. Researchers want to see if LIFU can reduce pain intensity and how the brain responds to pain, compared to a sham (inactive) treatment. You might be able to join if you are a veteran between 21 and 75 years old, have had daily back pain for at least three months (or half the days for six months), and rate your pain at 4 out of 10 or higher. The study aims to enroll 66 participants.
- Study design
- This interventional study plans to enroll 66 participants. It will compare the effects of low-intensity focused ultrasound (LIFU) to a sham stimulation.
- What's involved
- Participants will receive one session of LIFU and one session of sham treatment. Measures of central sensitization (how sensitive your nervous system is to pain) will be taken immediately before and within one hour after each session.
- Compensation
- Not stated in the trial record.
- Follow-up
- Measures of central sensitization are taken within one hour after each treatment session.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Mary R Lee, MD · PRINCIPAL_INVESTIGATOR · Washington D.C. Veterans Affairs Medical Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Measures of Central Sensitization - Thermal Pain Thresholdimmediately prior to 1 session LIFU and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post shamdays
For the first measure, the probe is placed on the skin on the ventral aspect of the forearm on the nondominant arm. The temperature is set at 32°C and the temperature is increased at a rate of 1°C/s to a maximum of 52°C. Participants will be asked to press a button when the heat reaches a painful level. The outcome is the temperature at this level. Heat PT are averaged over three trials each separated by 40 seconds. Thermal PT will be performed prior to and after LIFU. On each trial, the thermode is moved to a different site on the forearm to avoid sensitization and response suppression of cutaneous heat receptors.
- Measures of Central Sensitization - Temporal Summation of Painimmediately prior to 1 session LIFU and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post shamdays
The second measure refers to the perception of increasing pain in response to repeated same noxious stimuli delivered at a frequency of \> 0.33 Hz. Temporal summation of pain serves as a proxy measure of pain facilitation and CS. Individuals with enhanced temporal summation of pain have facilitated ascending nociceptive processing and reduced pain-modulatory capacities. Following the temporal summation of pain paradigm, three stimulus trains of trapezoid heat pulses of 1.5 s duration will be delivered to the dorsum of the dominant hand at an inter-pulse interval of 2.5 seconds at individual subject heat pain of 6/10 on numeric pain rating scale. A total of 5 stimuli will be delivered per train. Participants will be required to rate each stimulus (0-10). The Δ scores from 5th to 1st stimulus of each train will be averaged.
- Measures of Central Sensitization - Conditioned Modulation of Painimmediately prior to 1 session LIFU and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post shamdays
A type of counter-irritation paradigm that can be used as a proxy measure for descending anti-nociceptive or pain modulation activity. CPM involves presentation of a conditioning pain stimulus to a remote area of the body while a nociceptive (test) stimulus (TS) is applied to the contralateral (heterotopic) area. We will employ conditioned modulation of pain according to using a sequential conditioning-test stimulus protocol as recommended by. The test stimulus consists of a two-minute thermal stimulus applied with the thermode at a rating of 5/10 on the numeric pain rating scale. Participants will rate their perceived pain (0-10, numeric pain rating scale) every 15 seconds. This will be performed pre/post the conditioning stimulus. The conditioning stimulus will be a cold pressor test.. The non-dominant arm will be immersed in a cold-water bath (12°C) for two minutes. This method recruits inhibitory conditioned modulation of pain because it is a strong nociceptive stimulation.