Vagus nerve stimulation has been tested for chronic low back pain, but the studies so far are small, short and do not agree. The best-known study, a 2024 open-label pilot with no control group, reported that pain fell 22.5 mm on a 0 to 100 scale after three months of daily ear stimulation; 24 of the 30 adults enrolled were analysed at that point. A 2024 systematic review by Eid and colleagues, which pooled six randomized trials, concluded that the research still does not support the approach as a rehabilitation strategy for low back pain. Here is what each study found, what the studies do not show, and what to settle before you decide anything.
For help sorting nerve pain from muscle pain, and seeing where this research fits, read our full explainer on how the vagus nerve relates to pain.
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Quick facts as of 2026-11-11
| Question | Answer from the research |
|---|---|
| Condition in the 2024 pilot | Chronic low back pain; adults scoring 40 or more on a 0 to 100 pain scale |
| Best-known back-pain study | 2024 open-label pilot, 30 adults, no control group, 3 months (Tavares-Figueiredo and colleagues) |
| Systematic review of back-pain trials | Eid, George and Hady, 2024; 6 randomized trials drawn from 1,084 records found |
| Review conclusion | Still no research support for transcutaneous vagus nerve stimulation as a viable rehabilitation strategy (Eid, 2024) |
| gammaCore FDA clearance | Headache disorders only, per its 510(k) indications form (K211856, decision 2021-09-10) |
| Implanted VNS approved uses | Epilepsy, depression and arm rehabilitation after ischemic stroke, per Cleveland Clinic |
| Consumer vagus devices | Truvaga, Pulsetto and Apollo Neuro describe their products as wellness products; Nurosym describes itself as CE-certified. |
Can a vagus nerve stimulator help chronic back pain?
The back-pain research so far is promising in places and thin in others. The 2024 pilot reported large pain drops, but it had no control group. The 2024 Eid review, which looked only at randomized trials, did not find enough to support the approach for rehabilitation. A 2023 systematic review of auricular stimulation across chronic pain reached a more favorable view, and it named chronic low back pain as one of the areas with the best data. Read the cards below before you draw a conclusion, and note how small each group was.
What the studies found, study by study
2024 open-label pilot in chronic low back pain (Tavares-Figueiredo and colleagues)
The pilot was published in the Journal of Clinical Medicine pilot study on 13 December 2024.
| Study detail | What it found |
|---|---|
| Design | Open-label, single-arm pilot with no control group and no sham |
| People | 30 adults with chronic low back pain scoring 40 or more on a 0 to 100 scale; 27 evaluated at 1 month, 24 analysed at 3 months |
| Stimulation | Transcutaneous auricular vagus nerve stimulation, applied through the skin of the ear |
| Comparator | None |
| Length | 3 months, 30 minutes a day |
| Results | Pain score down 16.1 mm at 1 month (SD 17.9; p < 0.001) and down 22.5 mm at 3 months (SD 25; p < 0.001). Oswestry Disability Index down 11.9 points (SD 11.1) at 3 months. 51.9% reached a pain reduction of 20 mm or more. Half of patients reached 80% adherence. |
| Safety | No serious adverse events |
| Authors’ limit | Without a control group, the authors say the gains cannot be attributed to stimulation alone, and they call for a large randomized trial with a sham control. |
2024 trial: stimulation plus exercise vs rehabilitation plus exercise (Demircioglu, Ozden and Genc)
This trial was published in Complementary Therapies in Clinical Practice on 28 May 2024.
| Study detail | What it found |
|---|---|
| Design | Randomized, two groups |
| People | 60 patients with chronic low back pain |
| Stimulation | Auricular vagus nerve stimulation plus home exercise |
| Comparator | Conventional low back rehabilitation plus home exercise (an active comparator, not a sham) |
| Length | 5 days a week for 3 weeks |
| Results | Both groups improved on mobility, function, depression and sleep (p < 0.05). Pain level, endurance time and trunk flexion strength improved more in the stimulation group (p < 0.05). Some quadriceps strength and fall-risk scores improved more in the rehabilitation group (p < 0.05). |
| Authors’ wording | Stimulation “may be included” for patients “in whom conventional physical therapy is inadequate or not applicable” |
| Limits | No sham arm; the treatment period was 3 weeks |
2024 systematic review of six trials (Eid, George and Hady)
This review was published in BMC Musculoskeletal Disorders on 26 June 2024.
| Study detail | What it found |
|---|---|
| Design | Systematic review of randomized trials; searches of Google Scholar, PubMed, Web of Science, Cochrane and PEDro |
| People | Trials in adults whose low back pain had lasted over 3 months; 1,084 records found, 6 trials included |
| Risk of bias | 3 trials low (50%), 2 with some concerns (33.3%), 1 high (16.7%) |
| Conclusion | The review says there is still no research support for transcutaneous vagus nerve stimulation as a viable rehabilitation strategy |
| Authors’ call | High-quality trials with long-term follow-up on disability, quality of life and pain |
2023 systematic review of auricular stimulation for chronic and acute pain (Likar and colleagues)
This review appeared in Schmerz, published online on 2 January 2023 and in print in 2024.
| Study detail | What it found |
|---|---|
| Design | Systematic review rated on level of evidence and the Jadad scale |
| People | 1,105 patients treated with auricular VNS across 20 chronic pain studies, 10 acute postoperative pain studies and 7 experimental acute pain studies |
| Best-supported areas | Chronic low back pain, chronic cervical syndrome, chronic abdominal pain and chronic migraine, plus some postoperative settings |
| Results | Most studies showed less analgesic or opioid use. Three randomized trials in chronic pain showed pain reduction for up to 12 months. |
| Tolerance | The authors say “aVNS was very well tolerated” |
| Authors’ limits | Standardized parameters, quality-of-life outcomes and longer follow-up are needed |
2025 systematic review of nVNS vs heart rate variability biofeedback (Pellow and colleagues)
This review was published in the Scandinavian Journal of Pain in 2025.
| Study detail | What it found |
|---|---|
| Design | Systematic review of randomized trials published 2010 to 2023 |
| People | 813 participants across 10 articles (763 in nVNS groups) |
| Back-pain part | 1 of 9 nVNS studies was in chronic low back pain (22 people); the others were headache or migraine (6 studies, 603 people) and fibromyalgia symptoms (2 studies, 138 people) |
| Results | Across nVNS studies: 3 showed significant results for episode frequency, 6 for pain intensity and 3 for medication use |
| Authors’ conclusion | Moderate to high quality evidence that nVNS reduces headache frequency and is well tolerated; for chronic pain conditions, the authors say there is not enough literature to support either approach |
Registered and planned trials in back pain and chronic widespread pain
Two registered projects show where the research is heading, but neither has a result yet. The first is a National Institutes of Health research grant record for a planned study in chronic low back pain. It describes randomizing patients to real or sham stimulation for one month, with three months of follow-up, and it says the study would provide new options “if successful.” It is a plan, not a result.
The second is a registered trial on ClinicalTrials.gov in chronic widespread pain, not low back pain. It compares ear stimulation, a deep-exhalation method and a no-intervention group, with an estimated 100 participants. The record was last updated 2025-07-23 and listed the status as “Not yet recruiting.”
Studies in other conditions
These results belong to other conditions and devices. They do not carry over to back pain or to consumer wearables.
| Study | Condition and people | What it found |
|---|---|---|
| Lange and colleagues, 2011 (fibromyalgia implant pilot) | Treatment-resistant fibromyalgia; 14 people with a surgically implanted VNS device | 12 completed 3 months; 5 met composite efficacy criteria at 3 months; 2 did not tolerate stimulation. Open label, no control group. |
| Dolcini and colleagues, 2025 (auricular fibromyalgia pilot) | Fibromyalgia; 18 people, single group | Stimulation for 30 minutes, five times a week, for 4 weeks. Widespread pain index fell at week 4 (p = 0.004). |
What the studies do not show
- The 2024 pilot had no control group, so the authors say its pain drop cannot be credited to stimulation alone.
- The 2024 trial compared stimulation with active rehabilitation, not with a sham device, and ran for 3 weeks.
- The planned NIH-funded study and the registered trial are plans or registrations, not results.
- The fibromyalgia, headache and implanted-device results describe other conditions and other devices.
- None of the studies above is a home test for vagus nerve damage.
Why a research device is not a consumer product
The devices in these studies were run by researchers under a study plan, with set schedules and measured outcomes. Consumer devices are sold on a different basis, and the words used for each are not interchangeable.
| Term | What it means in these sources | Who uses it |
|---|---|---|
| FDA premarket approval (PMA) | The most stringent FDA device marketing application. Vivistim System (P210007, decision 2021-08-27) is approved for arm and hand function in chronic ischemic stroke patients, as an implanted device. | FDA Devices@FDA record |
| FDA 510(k) clearance, “Substantially Equivalent” | A decision that a device is substantially equivalent to a device already legally marketed. gammaCore Sapphire (K211856, 2021-09-10) lists headache indications only. | FDA 510(k) records |
| General wellness | A product sold for wellness, not for diagnosing or treating a condition | Truvaga, Pulsetto and Apollo Neuro describe themselves this way |
| CE mark | A European conformity mark | Nurosym says it is a certified device (CE) in Europe |
| FCC authorization | FCC authorization covers radio-frequency emissions and is required before a radio device is marketed in the United States | Pulsetto says it is FCC-certified; the FCC describes the authorization this way |
The FDA describes a 510(k) as a premarket submission showing a device is as safe and effective, that is, substantially equivalent, to a legally marketed device. It calls PMA the most stringent type of device marketing application, and De Novo an alternate pathway for novel devices of low to moderate risk. Read the full definitions on the FDA device approvals and clearances page.
Consumer wearables carry different words. Truvaga’s FAQ says its devices are considered a wellness product and are not covered by health insurance. Apollo Neuro’s help article calls its wearable a consumer wellness device that does not require FDA approval for sale, and says it is intended to help manage stress. Pulsetto says it is a general wellness device that does not claim to diagnose, treat, cure or prevent any medical condition. Nuropod says it is “scientifically proven to modulate the vagus nerve”; that is the maker’s wording, not a back-pain study.
Common mix-ups
Nerve pain and muscle pain are different
The Cleveland Clinic neuropathic pain page and a WebMD page on nociceptive pain describe two different kinds of pain.
| Type | How it is often described | What it is linked to |
|---|---|---|
| Nociceptive (tissue) | Dull, achy, sharp, throbbing or cramping; can worsen with coughing or laughing | Damage to tissues, most often from injury; commonly affects muscles, joints and bones (WebMD, 16 February 2026) |
| Neuropathic (nerve) | Burning, stabbing, electric shock-like, tingling, numbness or pins and needles | Nerve malfunction or damage, including spinal nerve compression (Cleveland Clinic, updated 11/13/2023) |
TENS is not vagus nerve stimulation
TENS sends a weak current through sticky pads on the skin for temporary pain relief. The NHS TENS guide says TENS does not work for everyone. A 2018 Cochrane review of TENS for fibromyalgia included 8 studies and 315 adults and found insufficient high-quality research to support or refute TENS for that condition. Its findings are about TENS, not about vagus nerve devices.
A gammaCore clearance is for headache
The gammaCore indications list headache disorders only, including migraine and cluster headache. None of the indications is back pain, neck pain, fibromyalgia or general pain.
Implanted devices are not wearables
The Cleveland Clinic VNS page describes an implanted device placed in the neck, approved as add-on therapy for certain seizures, for depression that has not responded to four or more antidepressants, and for arm and hand function after ischemic stroke.
Neck posture and vagus nerve claims
Many online routines link neck posture to the vagus nerve. A 2025 Cureus study of 84 young adults aged 19 to 45 found that a more forward head posture went with more sympathetic activity and less parasympathetic activity, measured through heart rate variability. Because the design is cross-sectional, it shows an association, not a cause, and heart rate variability is an indirect measure.
A 2025 Frontiers in Neurology paper proposes that forward-head phone use stretches neck ligaments and affects the vagus nerve. It is a hypothesis, supported by a retrospective review of 234 patients, and the authors also offer cervical treatments of their own. A 2026 Cochrane protocol plans a review of TENS for chronic neck pain; a protocol is a plan, not a result.
None of the studies above measures whether the vagus nerve heals, and none tests a timed routine as a vagus nerve reset. None defines symptoms of a sensitive vagus nerve; the studies measure pain scores, disability, sleep and heart rate variability.
Side effects and who should avoid vagus nerve devices
| Source | Device type | Side effects reported |
|---|---|---|
| Lange and colleagues, 2011 | Surgically implanted VNS (fibromyalgia) | Dry mouth, fatigue; side effects similar to those in epilepsy and depression VNS; 2 of 14 did not tolerate stimulation |
| Tavares-Figueiredo and colleagues, 2024 | Auricular pilot (back pain) | No serious adverse events |
| Likar and colleagues, 2023 | Auricular VNS, across pain studies | The authors say aVNS was very well tolerated |
| Truvaga maker statement | Consumer wearable | Fewer than 5% of participants in its clinical studies had mild effects: site discomfort or redness, muscle twitching, face, head or neck pain (including toothache), mild headache or mild dizziness |
| Cleveland Clinic, implanted VNS | Implanted device | Cough, hoarseness, voice change, neck or throat pain, shortness of breath, trouble swallowing and headache; serious ones include vocal cord paralysis, infection and device complications |
The makers of consumer devices list people who should not use them. Pulsetto lists heart conditions, irregular heartbeat, blood pressure problems, seizures or fainting, any diagnosed neurological condition, neck surgery, serious head injury, any active electronic implant such as a pacemaker, any metal implant or stent in or near the neck, pregnancy, cancer treatment, and broken or irritated skin on the neck. It is intended for adults aged 18 and over. Nuropod lists people who have had surgery to cut the vagus nerve, people with a severely low resting heart rate, pregnant women, and children. Truvaga says anyone with an active implantable medical device, such as a pacemaker or hearing aid implant, should not use it.
Pulsetto’s help center says total use should not exceed 120 minutes in 24 hours, and it asks for a break after active use. Truvaga’s maker says up to 24 sessions a day is safe.
Could I just do this myself?
The studies used set schedules, set devices and recorded scores at fixed points. Consumer devices are sold for general wellness, and makers do not describe them as back-pain devices. If you want to track your own pain, write down a daily score on a 0 to 10 scale and note what you were doing when it rose. The same routine shows what changes, and it gives your clinician something concrete. For daily activity limits, see back pain limits daily tasks.
When to get checked, and who to ask
The NHS says to call 999 or go to A&E, and not drive yourself, for any of these: sciatica on both sides; severe weakness or numbness in both legs, or getting worse; numbness around the genitals or anus; difficulty starting to pee, being unable to pee, or losing bladder control; or losing control of bowels. The NHS back pain guide also lists chest pain and changes in genital sensation or sexual function, and it lists onset after a serious accident. For the full checklist, see low back pain red flags.
The NHS says to see a GP if pain has not improved after a few weeks of home treatment, is getting worse, or stops you doing normal activities. The NHS also says to see a GP first if you are unsure what is causing your pain. You can read more on when to see a doctor for back pain.
The Cleveland Clinic nerve pain page lists care options including over-the-counter pain relievers, antiseizure drugs, antidepressants, topical lidocaine or capsaicin, nerve blocks, physical therapy, surgery and counseling. Talk to your prescriber about any medicine. It also says to call your provider for numbness, tingling, muscle weakness or frequently dropping held objects. In practice, that means a primary care clinician first, a physical therapist for rehabilitation, and a neurologist if nerve symptoms are the main concern.
Before you decide
- Ask your primary care clinician whether nerve symptoms fit what you feel.
- Ask the device maker which FDA or other authorization applies to the exact model, and what it is designed for.
- Ask for the label or user manual, and check the warnings against your heart history, implants and pregnancy status.
- Ask whether the device is sold as a wellness product or cleared for a specific use.
By BackToHealthTroy.com Editorial Team
This article is for general information purposes only and does not constitute medical advice. Consult your doctor or qualified healthcare provider before making changes to your health routine.