Chronic Back PainLIFU_PainNCT06906211
Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula
A study testing low intensity focused ultrasound (LIFU) in people with Chronic Back Pain and Chronic Pain (Back / Neck), run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.
Trial summary
In this study, the research team will use low-intensity focused ultrasound (LIFU) to temporarily change brain activity in a brain region that is known to be involved in chronic pain. Through this, the research team hopes to learn about how the brain area works in response to pain. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Chronic Back Pain, Chronic Pain (Back / Neck)
- What is being tested?
- low intensity focused ultrasound (LIFU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 26 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. Upper body sites include hand, wrist, elbow or shoulder. Lower sites include hip, knee, ankle or foot.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Evan Evan Lindeman, MS contact
United States1 site, 1 recruiting
- Recruiting
Washington DC Veterans Affairs Medical Center
Washington D.C., District of Columbia, 20422
Mary R Lee, MD, 202-745-8000 ext. 58128, mary.lee3@va.gov
Evan Lindeman, MS, evan.lindeman@va.gov
About this study
In this study, the research team will use low-intensity focused ultrasound (LIFU) to temporarily change brain activity in a brain region that is known to be involved in chronic pain. Through this, the research team hopes to learn about how the brain area works in response to pain. There are main questions this study aims to answer:
- The effect of LIFU to inhibit the posterior region of the insula (PI) compared to sham stimulation in individuals with chronic back pain (CBP) and widespread pain symptoms.
- The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of the Neurologic Pain Signature (NPS) in response to evoked thermal pain.
- The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of Tonic Pain Signature in response to tonic pain.
Read the detailed description
Chronic pain is a major public health problem. An estimated 100 million Americans have experienced chronic pain producing significant economic and social burden. The estimated annual cost of chronic pain is as high as $635 billion. Pharmacological treatments frequently require the use of opioids resulting in a major epidemic of abuse in the United States. New, non-addicting treatments for pain are critically needed. Neuromodulation with low-intensity focused ultrasound (LIFU) could represent a non-pharmacological treatment for chronic pain. The millimeter spatial specificity of LIFU makes it a powerful alternative to both invasive neurosurgical procedures and other noninvasive brain stimulation techniques. One promising target to treat chronic pain is the insular cortex. The insula as a key brain area involved in both sensory and affective components of chronic pain, including central sensitization processes which occur with pain chronicity. The insula is inaccessible using conventional noninvasive neuromodulatory techniques like transcranial magnetic stimulation. In contrast, LIFU can be focused deeply and provides the spatial resolution to resolve individual sub-regions of the insula. This is relevant to pain as the posterior subregion of the insula (PI) receives nociceptive input from spinothalamic tracts, relays it to the anterior insula which integrates expectation, awareness, and emotion to form the overall experience of pain. Therefore, using LIFU can address a gap in knowledge regarding the causal role of insular subregions in modulating pain response and CS processes. The preliminary data indicate that LIFU to PI reduces laboratory measures of central sensitization and evoked pain in healthy controls but there was no such effect of LIFU to anterior insula. Building on these results, the overall objective of this proposal is to examine the effect of LIFU to PI on the central sensitization processes that are a key feature of chronic pain syndromes and on neural response to evoked and tonic pain/pain intensity. The investigators will employ well validated laboratory measures of central sensitization and multivariate measures of neural response to evoked (Neurologic Pain Signature, NPS) and tonic (Tonic Pain Signature) pain. The chronic pain condition that the investigators will focus on in this study will be chronic back pain (CBP) with widespread pain widespread pain as the back is the most common site of chronic pain, is significantly more likely to be severe in the veteran population, and it commonly occurs with features of central sensitization. Eligible participants will have CBP with symptoms of widespread pain.
- Conditions
- Chronic Back Pain, Chronic Pain (Back / Neck)
- Being tested
- low intensity focused ultrasound (LIFU)
- Keywords
- low intensity focused ultrasound, chronic back pain, chronic pain, functional magnetic resonance imaging
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low intensity focused ultrasound (LIFU)Device
Low-intensity focused ultrasound (LIFU) provides an energy source with millimeter resolution that can be focused anywhere in the brain safely and effectively for non-invasive and transient neuromodulation. LIFU is an important advance and of great significance for brain-mapping efforts, diagnostics, and therapies in neuroscience and particularly promising for addiction therapy as it provides unprecedented non-surgical access to the brain regardless of depth. Much lower intensities of focused ultrasound (LIFU) are used so that tissue damage does not occur, but neural activity can be modulated. LIFU utilizes acoustic energy at much lower levels to affect tissue by mechanical effects.
| Study group | Role | What they receive |
|---|---|---|
| LIFU/Sham | Other | double-blind, sham-controlled, crossover study in N=66 individuals with Chronic Back Pain Receives: Device: low intensity focused ultrasound (LIFU) |
| Sham/LIFU | Other | double-blind, sham-controlled, crossover study in N=66 individuals with Chronic Back Pain Receives: Device: low intensity focused ultrasound (LIFU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of Central Sensitization - Thermal Pain Threshold
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.
Measured: immediately prior to 1 session LIFU and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post shamdays
Measures of Central Sensitization - Temporal Summation of Pain
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.
Measured: immediately prior to 1 session LIFU and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post shamdays
Measures of Central Sensitization - Conditioned Modulation of Pain
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.
Measured: immediately prior to 1 session LIFU and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post shamdays
Secondary outcomes (2)
Neurologic Pain Signature
A secondary outcome is the pain intensity and magnitude of the NPS in response to evoked thermal pain using task-based functional magnetic resonance imaging.
Measured: immediately prior to 1 session LIFU and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post shamdays
Tonic Pain Signature
A secondary outcome is the pain intensity and magnitude of Tonic Pain Signature in response to tonic pain using resting-state functional magnetic resonance imaging.
Measured: immediately prior to 1 session LIFU and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post sham
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start15 Jan 2025
- Primary completion26 Jan 2028 (estimated)
- Study completion26 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- within-subject, randomized, double-blind, sham-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington D.C. Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mary R Lee, MD, Principal investigator, Washington D.C. Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906211
- Sponsor's protocol ID
- 1781312
- Acronym
- LIFU_Pain
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: behavioral and imaging data
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula
- ClinicalTrials.gov ID
- NCT06906211
- Acronym / sponsor ID
- LIFU_Pain / 1781312
- Conditions
- Chronic Back Pain, Chronic Pain (Back / Neck)
- Keywords
- low intensity focused ultrasound, chronic back pain, chronic pain, functional magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Washington D.C. Veterans Affairs Medical CenterUS federal agency
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 26 Jan 2028 (estimated)
- Study completion
- 26 Jan 2028 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the research team will use low-intensity focused ultrasound (LIFU) to temporarily change brain activity in a brain region that is known to be involved in chronic pain. Through this, the research team hopes to learn about how the brain area works in response to pain. There are main questions this study aims to answer:
- The effect of LIFU to inhibit the posterior region of the insula (PI) compared to sham stimulation in individuals with chronic back pain (CBP) and widespread pain symptoms.
- The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of the Neurologic Pain Signature (NPS) in response to evoked thermal pain.
- The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of Tonic Pain Signature in response to tonic pain.
Detailed description
Chronic pain is a major public health problem. An estimated 100 million Americans have experienced chronic pain producing significant economic and social burden. The estimated annual cost of chronic pain is as high as $635 billion. Pharmacological treatments frequently require the use of opioids resulting in a major epidemic of abuse in the United States. New, non-addicting treatments for pain are critically needed. Neuromodulation with low-intensity focused ultrasound (LIFU) could represent a non-pharmacological treatment for chronic pain. The millimeter spatial specificity of LIFU makes it a powerful alternative to both invasive neurosurgical procedures and other noninvasive brain stimulation techniques. One promising target to treat chronic pain is the insular cortex. The insula as a key brain area involved in both sensory and affective components of chronic pain, including central sensitization processes which occur with pain chronicity. The insula is inaccessible using conventional noninvasive neuromodulatory techniques like transcranial magnetic stimulation. In contrast, LIFU can be focused deeply and provides the spatial resolution to resolve individual sub-regions of the insula. This is relevant to pain as the posterior subregion of the insula (PI) receives nociceptive input from spinothalamic tracts, relays it to the anterior insula which integrates expectation, awareness, and emotion to form the overall experience of pain. Therefore, using LIFU can address a gap in knowledge regarding the causal role of insular subregions in modulating pain response and CS processes. The preliminary data indicate that LIFU to PI reduces laboratory measures of central sensitization and evoked pain in healthy controls but there was no such effect of LIFU to anterior insula. Building on these results, the overall objective of this proposal is to examine the effect of LIFU to PI on the central sensitization processes that are a key feature of chronic pain syndromes and on neural response to evoked and tonic pain/pain intensity. The investigators will employ well validated laboratory measures of central sensitization and multivariate measures of neural response to evoked (Neurologic Pain Signature, NPS) and tonic (Tonic Pain Signature) pain. The chronic pain condition that the investigators will focus on in this study will be chronic back pain (CBP) with widespread pain widespread pain as the back is the most common site of chronic pain, is significantly more likely to be severe in the veteran population, and it commonly occurs with features of central sensitization. Eligible participants will have CBP with symptoms of widespread pain.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- within-subject, randomized, double-blind, sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| LIFU/Sham | Other | Device: low intensity focused ultrasound (LIFU)double-blind, sham-controlled, crossover study in N=66 individuals with Chronic Back Pain |
| Sham/LIFU | Other | Device: low intensity focused ultrasound (LIFU)double-blind, sham-controlled, crossover study in N=66 individuals with Chronic Back Pain |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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. Upper body sites include hand, wrist, elbow or shoulder. Lower sites include hip, knee, ankle or foot.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low intensity focused ultrasound (LIFU)Low-intensity focused ultrasound (LIFU) provides an energy source with millimeter resolution that can be focused anywhere in the brain safely and effectively for non-invasive and transient neuromodulation. LIFU is an important advance and of great significance for brain-mapping efforts, diagnostics, and therapies in neuroscience and particularly promising for addiction therapy as it provides unprecedented non-surgical access to the brain regardless of depth. Much lower intensities of focused ultrasound (LIFU) are used so that tissue damage does not occur, but neural activity can be modulated. LIFU utilizes acoustic energy at much lower levels to affect tissue by mechanical effects. | Device | LIFU/Sham, Sham/LIFU |
Primary outcome
Measures of Central Sensitization - Thermal Pain Threshold
Time frame: immediately 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 Pain
Time frame: immediately 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 Pain
Time frame: immediately 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.
2 secondary outcomes
Neurologic Pain Signature
Time frame: immediately prior to 1 session LIFU and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post shamdays
Tonic Pain Signature
Time frame: immediately prior to 1 session LIFU and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post sham
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes. behavioral and imaging data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evan Evan Lindeman, MS contact
Mary R Lee, MD principal investigator
Washington D.C. Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low intensity focused ultrasound (LIFU) in people with Chronic Back Pain and Chronic Pain (Back / Neck), run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary R Lee, MD (202-745-8000 ext. 58128, mary.lee3@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures of Central Sensitization - Thermal Pain Threshold (time frame: immediately 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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.