Low Back PainNCT03959111
Auricular Vagus Nerve Stimulation for Chronic Pain
A study testing Stimulation at Location 1 and Stimulation at Location 2 in people with Low Back Pain, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This proposal aims to investigate the treatment effect and underlying mechanism of transcutaneous acupuncture stimulation on chronic low back pain. We believe that this study, if successful, will provide new treatment options for chronic low back pain, reduce the use of opioid analgesics in chronic pain management… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Stimulation at Location 1 and Stimulation at Location 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2019to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers 18-65 years of age.
- Meet the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by a referring physician.
- Received stable treatment or no treatment in the past month.
- At least a 10th grade English-reading level. English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.
Who cannot join
- Specific causes of back pain (e.g., epidural abscess, compression fracture, spondyloarthropathy, malignancy, cauda equina syndrome) or radicular pain, radiculopathy, or spinal canal stenosis. Complicated back problems (e.g., prior back surgery, medico-legal issues).
- Presence of headache/migraine, as well as widespread body pain such as fibromyalgia.
- The intent to undergo surgery during participation in the study.
- History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcomes (e.g., asthma or claustrophobia).
- Presence of any contraindications to MRI scanning (e.g., cardiac pacemaker, metal implants, fear of enclosed spaces, pregnancy, cannot lie still in fMRI scanner).
- Conditions that might confound longitudinal effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis).
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- Pregnant or lactating.
- Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1).
- Active substance abuse disorders within the last 24 months (based on subject self-report).
- Use of prescription steroids for pain during the past six months.
- Presence of any other acute or chronic pain disorder.
- Any medical conditions, such as peripheral neuropathy, that could affect the results of QST.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
About this study
Official title: Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Pain
This proposal aims to investigate the treatment effect and underlying mechanism of transcutaneous acupuncture stimulation on chronic low back pain. We believe that this study, if successful, will provide new treatment options for chronic low back pain, reduce the use of opioid analgesics in chronic pain management, and enhance our understanding of the underlying mechanism of nerve stimulation treatment, as well as the pathophysiology and development of chronic pain.
- Conditions
- Low Back Pain
- Being tested
- Stimulation at Location 1, Stimulation at Location 2
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation at Location 1Other
Stimulation parameters will include 1) density wave adjusted to 20Hz with less than 1 ms pulse width, 2) intensity adjusted based on the tolerance of the patient (moderate tolerable stimulation without pain), and 3) treatment will be applied 1 time per day, 5 times per week for four weeks (on-site tVNS treatment plus self-administration at home).
Stimulation at Location 2Other
Stimulation parameters will include 1) density wave adjusted to 20Hz with less than 1 ms pulse width, 2) intensity adjusted based on the tolerance of the patient (moderate tolerable stimulation without pain), and 3) treatment will be applied 1 time per day, 5 times per week for four weeks (on-site tVNS treatment plus self-administration at home).
| Study group | Role | What they receive |
|---|---|---|
| Ear stimulation (Location 1) | Experimental | Not described Receives: Other: Stimulation at Location 1 |
| Ear stimulation (Location 2) | Experimental | Not described Receives: Other: Stimulation at Location 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Back Pain Intensity
This is a uni-dimensional measure of chronic low back pain intensity. It uses an 11-point numeric scale (0 indicate no pain, and 10 indicates max level of pain that can be imagined). We will use it to measure the patient's average pain intensity in the past week, which will be measured at the beginning and end of the study.
Measured: 1 month
Secondary outcomes (5)
Roland-Morris Disability Questionnaire Score
The Roland-Morris Disability Questionnaire (RMDQ) is a widely used self-reported measure of physical disability specifically designed for individuals with low back pain. The questionnaire assesses the impact of back pain on daily activities. The total score ranges from 0 to 24, where: 0 indicates no disability, 24 indicates severe disability.
Measured: 1 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Scores
The PROMIS, funded by the NIH, is a system containing reliable, flexible, precise, and responsive assessment tools that have been widely validated in numerous samples. 29 items covering seven domains and one additional question about pain intensity. Here we focus on Pain Interference (4 items, raw score range 4-20, T-score range roughly 41-76, mean and SD in chronic pain patients is 67.1 and 5.79. The 67.1indicates the population mean in chronic pain patients with a standard deviation of 5.79 based on publication PMCID: PMC8412832). Higher T-scores = more pain interference. We compared pre- and post-treatment difference of the pain interference subscore.
Measured: baseline and post-treatment
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) is a 15-item questionnaire assessing the extent to which individuals magnify the threat of pain and feel helpless in the presence of pain. Due to an administration error, the full 15-item PCS was not collected as intended: participants received an incomplete version of the questionnaire (missing items), which prevents calculation of valid total and subscale scores. This error occurred during data collection and affected all attempted administrations (including both planned time points, where applicable); therefore, no participants have analyzable PCS data to report for this outcome measure.
Measured: baseline and post-treatment
The Pennebaker Inventory of Limbic Languidness
The Pennebaker Inventory of Limbic Languidness (PILL) is a self-report questionnaire assessing the frequency of common physical symptoms. Participants rate how often they have experienced each symptom over a specified retrospective period using a 5-point Likert scale. The PILL includes a broad range of symptoms, including pain-related items (e.g., headache, back pain, sore muscles). The PILL was administered at baseline only to characterize baseline symptom sensitivity/awareness and to reduce participant burden. Total scores are computed as the sum of 53 items rated from 1-5 (total score range: 53-265), with higher scores indicating more frequent symptoms (worse outcome) and lower scores indicating less frequent symptoms (better outcome).
Measured: Baseline
Resting State Functional Connectivity Changes of the PAG
Resting state functional connectivity refers to the statistical relationship between the time-series activity of different brain regions as measured by functional MRI (fMRI). Functional connectivity changes of the periaqueductal gray (PAG) at rest refer to alterations in the neural communication between the PAG and other brain regions when a subject is not actively engaged in a task. The PAG, located in the midbrain, plays a critical role in pain modulation, defensive behavior, and autonomic regulation.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start17 Oct 2019
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Kong, Massachusetts General Hospital
- Investigators
- Jian Kong, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959111
- Sponsor's protocol ID
- 2016P000678
- Status last verified
- Feb 2026
- First submitted
- 20 May 2019
- Last updated
- 11 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Y, Li T, Yan K, Wu J, Reddy S, Sacca V, Ursitti AK, Zhu M, Hodges S, Chen L, Kong J. Both Transcutaneous Auricular Vagus Nerve Stimulation and Great Auricular Nerve Stimulation Modulate Functional and Structural Connectivity of Brainstem Nuclei in Chronic Low Back Pain. Neuromodulation. 2026 Jun;29(4):597-606. doi: 10.1016/j.neurom.2025.08.415. Epub 2025 Oct 15.
PubMed 41091086
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Pain
- ClinicalTrials.gov ID
- NCT03959111
- Acronym / sponsor ID
- 2016P000678
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Posted 11 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal aims to investigate the treatment effect and underlying mechanism of transcutaneous acupuncture stimulation on chronic low back pain. We believe that this study, if successful, will provide new treatment options for chronic low back pain, reduce the use of opioid analgesics in chronic pain management, and enhance our understanding of the underlying mechanism of nerve stimulation treatment, as well as the pathophysiology and development of chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ear stimulation (Location 1) | Experimental | Other: Stimulation at Location 1 |
| Ear stimulation (Location 2) | Experimental | Other: Stimulation at Location 2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteers 18-65 years of age.
- Meet the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by a referring physician.
- Received stable treatment or no treatment in the past month.
- At least a 10th grade English-reading level. English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.
Key exclusion criteria (12 listed)
- Specific causes of back pain (e.g., epidural abscess, compression fracture, spondyloarthropathy, malignancy, cauda equina syndrome) or radicular pain, radiculopathy, or spinal canal stenosis. Complicated back problems (e.g., prior back surgery, medico-legal issues).
- Presence of headache/migraine, as well as widespread body pain such as fibromyalgia.
- The intent to undergo surgery during participation in the study.
- History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcomes (e.g., asthma or claustrophobia).
- Presence of any contraindications to MRI scanning (e.g., cardiac pacemaker, metal implants, fear of enclosed spaces, pregnancy, cannot lie still in fMRI scanner).
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 |
|---|---|---|
| Stimulation at Location 1Stimulation parameters will include 1) density wave adjusted to 20Hz with less than 1 ms pulse width, 2) intensity adjusted based on the tolerance of the patient (moderate tolerable stimulation without pain), and 3) treatment will be applied 1 time per day, 5 times per week for four weeks (on-site tVNS treatment plus self-administration at home). | Other | Ear stimulation (Location 1) |
| Stimulation at Location 2Stimulation parameters will include 1) density wave adjusted to 20Hz with less than 1 ms pulse width, 2) intensity adjusted based on the tolerance of the patient (moderate tolerable stimulation without pain), and 3) treatment will be applied 1 time per day, 5 times per week for four weeks (on-site tVNS treatment plus self-administration at home). | Other | Ear stimulation (Location 2) |
Primary outcome
Low Back Pain Intensity
Time frame: 1 month
This is a uni-dimensional measure of chronic low back pain intensity. It uses an 11-point numeric scale (0 indicate no pain, and 10 indicates max level of pain that can be imagined). We will use it to measure the patient's average pain intensity in the past week, which will be measured at the beginning and end of the study.
5 secondary outcomes
Roland-Morris Disability Questionnaire Score
Time frame: 1 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Scores
Time frame: baseline and post-treatment
Pain Catastrophizing Scale
Time frame: baseline and post-treatment
The Pennebaker Inventory of Limbic Languidness
Time frame: Baseline
Resting State Functional Connectivity Changes of the PAG
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41091086Li Y, Li T, Yan K, Wu J, Reddy S, Sacca V, Ursitti AK, Zhu M, Hodges S, Chen L, Kong J. Both Transcutaneous Auricular Vagus Nerve Stimulation and Great Auricular Nerve Stimulation Modulate Functional and Structural Connectivity of Brainstem Nuclei in Chronic Low Back Pain. Neuromodulation. 2026 Jun;29(4):597-606. doi: 10.1016/j.neurom.2025.08.415. Epub 2025 Oct 15.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jian Kong principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation at Location 1 and Stimulation at Location 2 in people with Low Back Pain, run by Massachusetts General Hospital 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 12 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: finished, as of the sponsor's last update on 11 Mar 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?
Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Back Pain Intensity (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03959111, which also lists 1 linked publication.
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 11 Mar 2026.