Low Back PainVALOMNCT05639270
Pilot Study of Vagal Stimulation in Chronic Low Back Pain
A study testing use of an auricular electrode in people with Low Back Pain, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
Low back pain is a major public health problem. It is the leading cause of disability in the world. The factors that lead to chronicity of low back pain are multi-factorial and are essentially represented by psychosocial factors (catastrophism, kinesiophobia, algophobia job dissatisfaction, emotional problems such as… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- use of an auricular electrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Feb 2023to 14 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low back pain with a VAS greater than or equal to 40 that has been ongoing for more than 3 months
- Failed or insufficiently relieved by private physiotherapy
- Failed or insufficiently relieved or intolerant of level II analgesics
- No change in therapy envisaged within one month.
Who cannot join
- Non-common low back pain will not be accepted (presence of red flags).
- Auricular canal not adapted to the stimulation device.
- Use of another type of electrical device (pacemaker or TENS).
- History of vagotomy.
- Heart rhythm disorder.
- Presence of a cochlear implant on the stimulation side
Show all 12Show fewer
- Pregnancy in progress or planned during the study period
- Adult protected by law or patient under guardianship or curator
- Person unable to give consent.
- Participation in other ongoing biomedical research
- Absence of express informed consent after a reflection period
- Not being affiliated to a French social security system or being a beneficiary of such a system
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Montpellier
Montpellier, France, 34295
CHU Nîmes - Le Grau du Roi
Nîmes, 30240
About this study
Official title: Pilot Study Before/After of Vagal Stimulation in Chronic Low Back Pain
Low back pain is a major public health problem. It is the leading cause of disability in the world. The factors that lead to chronicity of low back pain are multi-factorial and are essentially represented by psychosocial factors (catastrophism, kinesiophobia, algophobia job dissatisfaction, emotional problems such as depression, anxiety, stress, injustice, etc.).
Pain is a multimodal experience that involves different brain structures that are activated by the pain signal and involve the autonomic nervous system (ANS). The vagus nerve is the main actor of one of the two branches of the ANS, the parasympathetic system, which acts as a "slow-down".
Read more
The vagus nerve participates in the inter-neuronal transmission of key neurotransmitters for mood, alertness, attention and motivation.
Vagal stimulation has been used for many years as an analgesic device in chronic pain (vascular pain (facial vascular pain, fibromyalgia, visceral pain, gastrointestinal and pelvic pain...)
To date, no study has been conducted on the value of vagal stimulation in chronic low back pain.
Read the detailed description
Low back pain is a major public health problem. It is the leading cause of disability in the world.
The factors that lead to chronicity of low back pain are multifactorial, which explains the modest effectiveness of both drug treatments and multidisciplinary programs (analgesic drug interventions, non-pharmacological interventions with rehabilitation, physical exercise, psychotherapy, spinal ergonomics, meditation, yoga, etc.) in the treatment of low back pain. psychotherapy, spinal ergonomics, meditation, yoga...) in chronic forms. These factors of chronicization are essentially represented by psychosocial factors (catastrophism, kinesiophobia, algophobia, job dissatisfaction, emotional problems such as depression, anxiety stress, injustice...)
In the chronic low back pain population, pain is a multimodal experience that involves different brain structures (insula, anterior cingulate cortex, amygdala and prefrontal cortex). These structures are activated by the pain signal and involve the autonomic nervous system (ANS).
The vagus nerve is the main actor of one of the two branches of the ANS, the parasympathetic system, which acts as a "slow-down".
The vagus nerve is involved in the inter-neuronal transmission of key neurotransmitters for mood, alertness, attention and motivation (serotonin, dopamine, oxytocin and noradrenaline).
It is one of the longest nerves in the human body, originating from the base of the brain (nucleus tractus solitarius) and innervating most of the organs (heart, lung, stomach, liver, spleen, kidneys, gallbladder, pancreas, intestines). It allows the integration of information from the periphery (pain, stress, emotions), slows down the heart rate after a stress, reduces the caliber of the bronchial tubes to help breathing, reduces the inflammatory response, participates in digestion and in the communication with the digestive microbiota.
Indeed, there seems to be an alteration of the vagal function in chronic pain patients patients: the vagus nerve is involved in the modulation of pain at different levels (medullary, cerebral) (medullary, cerebral) but also on the different components of pain (sensory, affective emotional, behavioral).
The benefit of the stimulation of the vagus would be mediated by a modulation of afferent information (stress, pain, emotion) associated with a benefit of "relaxation" conveyed by the efferent fibers (cardiac, pulmonary effect...).
This stimulation of the vagus nerve is done through an atrial electrode that stimulates the atrial branch of the vagus nerve.
To date, no study has been conducted on the value of vagal stimulation in chronic low back pain.
Because of the multifactorial mechanisms involved in this pathology, this type of therapy appears to be a useful complement to the management of our patients.
This pilot study will allow us to evaluate the feasibility of a larger study with a placebo arm.
The evaluation of tolerance and adherence to this therapy will be taken into account.
- Conditions
- Low Back Pain
- Being tested
- use of an auricular electrode
- Keywords
- Vagus nerve stimulation, low back pain
- 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.
use of an auricular electrodeDevice
Use of the auricular electrode throughout the duration of the study (30minutes/day) combined with assessment of pain, tolerance, vagal tone.
| Study group | Role | What they receive |
|---|---|---|
| low back pain | Experimental | The experimental intervention consists of vagal stimulation using the Tens Eco device with an auricular electrode and conductive gel.
The stimulation will have an intensity of 25 Hz, lasting 30 minutes, once a day, for 3 months.
An evaluation of the pain will be done every week by phone for the first month and then in consultation at one month and at 3 months. Receives: Device: use of an auricular electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline pain at 1 month
evaluated by a Visual Analog Scale (VAS, 0 the worst result and 100 the best result)
Measured: between baseline and 1 month
Secondary outcomes (18)
change from baseline functional disability at 1 month
evaluated by Oswestry score The questionnaire consists of 10 questions, concerning: pain, self-care, load carrying, walking, sitting, standing, sleep, sexual life, social life, travel.
Score between 0 and 20%: minimal disability Score between 21 and 40%: moderate disability Score between 41 and 60% : severe disability Score between 61 and 80% : major disability Score between 81 and 100% : bedridden patient
Measured: between baseline and 1 month
change from baseline functional disability at 3 month
evaluated by Oswestry score The questionnaire consists of 10 questions, concerning: pain, self-care, load carrying, walking, sitting, standing, sleep, sexual life, social life, travel.
Score between 0 and 20%: minimal disability Score between 21 and 40%: moderate disability Score between 41 and 60% : severe disability Score between 61 and 80% : major disability Score between 81 and 100% : bedridden patient
Measured: between baseline and 3 month
change from baseline quality of life at 1 month
evaluated by EQ-5D-5L score (0 to 20, 0 the better, and 20 the worst ; 0 to 100 for the L part, 0 the worst and 100 the better)
Measured: between baseline and 1 month
change from baseline quality of life at 3 month
evaluated by EQ-5D-5L score (0 to 20, 0 the better, and 20 the worst ; 0 to 100 for the L part, 0 the worst and 100 the better)
Measured: between baseline and 3 month
change from baseline anxiety and depression at 1 month
evaluated by HAD (Hospital Anxiety and Depression scale) score
Measured: between baseline and 1 month
change from baseline anxiety and depression at 3 month
evaluated by HAD (Hospital Anxiety and Depression scale) score
Measured: between baseline and 3 month
change from baseline catastrophism at 1 month
evaluated by PCS (Pain Catastrophizing Scale) score
Measured: between baseline and 1 month
change from baseline catastrophism at 3 month
evaluated by PCS (Pain Catastrophizing Scale) score
Measured: between baseline and 3 month
evolution of use of painkillers at 1 month
Measured: between baseline and 1 month
evolution of use of painkillers at 3 month
Measured: between baseline and 3 month
evaluation of device adherence at 1 month
number of stimulations performed
Measured: between baseline and 1 month
evaluation of device adherence at 3 month
number of stimulations performed
Measured: between baseline and 3 month
evaluation of device tolerance at 1 month
number of adverse events
Measured: between baseline and 1 month
evaluation of device tolerance at 3 month
number of adverse events
Measured: between baseline and 3 month
evaluation of device satisfaction at 1 month
Lickert scale from 1 to 5.
Measured: between baseline and 1 month
evaluation of device satisfaction at 3 month
Lickert scale from 1 to 5.
Measured: between baseline and 3 month
change from baseline vagal tone at 1 month
evaluated by Heart Rate variability
Measured: between baseline and 1 month
change from baseline vagal tone at 3 month
evaluated by Heart Rate variability
Measured: between baseline and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start15 Feb 2023
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 University Hospital, MontpellierThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639270
- Sponsor's protocol ID
- RECHMPL21_0598
- Acronym
- VALOM
- Status last verified
- Jun 2026
- First submitted
- 28 Nov 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tavares-Figueiredo I, Pers YM, Duflos C, Herman F, Sztajnzalc B, Lecoq H, Laffont I, Dupeyron AF, Homs AF. Effect of Transcutaneous Auricular Vagus Nerve Stimulation in Chronic Low Back Pain: A Pilot Study. J Clin Med. 2024 Dec 13;13(24):7601. doi: 10.3390/jcm13247601.
PubMed 39768526
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Before/After of Vagal Stimulation in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05639270
- Acronym / sponsor ID
- VALOM / RECHMPL21_0598
- Conditions
- Low Back Pain
- Keywords
- Vagus nerve stimulation, low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 6 Dec 2022 (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.
Low back pain is a major public health problem. It is the leading cause of disability in the world. The factors that lead to chronicity of low back pain are multi-factorial and are essentially represented by psychosocial factors (catastrophism, kinesiophobia, algophobia job dissatisfaction, emotional problems such as depression, anxiety, stress, injustice, etc.).
Pain is a multimodal experience that involves different brain structures that are activated by the pain signal and involve the autonomic nervous system (ANS). The vagus nerve is the main actor of one of the two branches of the ANS, the parasympathetic system, which acts as a "slow-down".
The vagus nerve participates in the inter-neuronal transmission of key neurotransmitters for mood, alertness, attention and motivation.
Vagal stimulation has been used for many years as an analgesic device in chronic pain (vascular pain (facial vascular pain, fibromyalgia, visceral pain, gastrointestinal and pelvic pain...)
To date, no study has been conducted on the value of vagal stimulation in chronic low back pain.
Detailed description
Low back pain is a major public health problem. It is the leading cause of disability in the world.
The factors that lead to chronicity of low back pain are multifactorial, which explains the modest effectiveness of both drug treatments and multidisciplinary programs (analgesic drug interventions, non-pharmacological interventions with rehabilitation, physical exercise, psychotherapy, spinal ergonomics, meditation, yoga, etc.) in the treatment of low back pain. psychotherapy, spinal ergonomics, meditation, yoga...) in chronic forms. These factors of chronicization are essentially represented by psychosocial factors (catastrophism, kinesiophobia, algophobia, job dissatisfaction, emotional problems such as depression, anxiety stress, injustice...)
In the chronic low back pain population, pain is a multimodal experience that involves different brain structures (insula, anterior cingulate cortex, amygdala and prefrontal cortex). These structures are activated by the pain signal and involve the autonomic nervous system (ANS).
The vagus nerve is the main actor of one of the two branches of the ANS, the parasympathetic system, which acts as a "slow-down".
The vagus nerve is involved in the inter-neuronal transmission of key neurotransmitters for mood, alertness, attention and motivation (serotonin, dopamine, oxytocin and noradrenaline).
It is one of the longest nerves in the human body, originating from the base of the brain (nucleus tractus solitarius) and innervating most of the organs (heart, lung, stomach, liver, spleen, kidneys, gallbladder, pancreas, intestines). It allows the integration of information from the periphery (pain, stress, emotions), slows down the heart rate after a stress, reduces the caliber of the bronchial tubes to help breathing, reduces the inflammatory response, participates in digestion and in the communication with the digestive microbiota.
Indeed, there seems to be an alteration of the vagal function in chronic pain patients patients: the vagus nerve is involved in the modulation of pain at different levels (medullary, cerebral) (medullary, cerebral) but also on the different components of pain (sensory, affective emotional, behavioral).
The benefit of the stimulation of the vagus would be mediated by a modulation of afferent information (stress, pain, emotion) associated with a benefit of "relaxation" conveyed by the efferent fibers (cardiac, pulmonary effect...).
This stimulation of the vagus nerve is done through an atrial electrode that stimulates the atrial branch of the vagus nerve.
To date, no study has been conducted on the value of vagal stimulation in chronic low back pain.
Because of the multifactorial mechanisms involved in this pathology, this type of therapy appears to be a useful complement to the management of our patients.
This pilot study will allow us to evaluate the feasibility of a larger study with a placebo arm.
The evaluation of tolerance and adherence to this therapy will be taken into account.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| low back pain | Experimental | Device: use of an auricular electrodeThe experimental intervention consists of vagal stimulation using the Tens Eco device with an auricular electrode and conductive gel. The stimulation will have an intensity of 25 Hz, lasting 30 minutes, once a day, for 3 months. An evaluation of the pain will be done every week by phone for the first month and then in consultation at one month and at 3 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Low back pain with a VAS greater than or equal to 40 that has been ongoing for more than 3 months
- Failed or insufficiently relieved by private physiotherapy
- Failed or insufficiently relieved or intolerant of level II analgesics
- No change in therapy envisaged within one month.
Key exclusion criteria (12 listed)
- Non-common low back pain will not be accepted (presence of red flags).
- Auricular canal not adapted to the stimulation device.
- Use of another type of electrical device (pacemaker or TENS).
- History of vagotomy.
- Heart rhythm disorder.
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 |
|---|---|---|
| use of an auricular electrodeUse of the auricular electrode throughout the duration of the study (30minutes/day) combined with assessment of pain, tolerance, vagal tone. | Device | low back pain |
Primary outcome
change from baseline pain at 1 month
Time frame: between baseline and 1 month
evaluated by a Visual Analog Scale (VAS, 0 the worst result and 100 the best result)
18 secondary outcomes
change from baseline functional disability at 1 month
Time frame: between baseline and 1 month
change from baseline functional disability at 3 month
Time frame: between baseline and 3 month
change from baseline quality of life at 1 month
Time frame: between baseline and 1 month
change from baseline quality of life at 3 month
Time frame: between baseline and 3 month
change from baseline anxiety and depression at 1 month
Time frame: between baseline and 1 month
change from baseline anxiety and depression at 3 month
Time frame: between baseline and 3 month
change from baseline catastrophism at 1 month
Time frame: between baseline and 1 month
change from baseline catastrophism at 3 month
Time frame: between baseline and 3 month
evolution of use of painkillers at 1 month
Time frame: between baseline and 1 month
evolution of use of painkillers at 3 month
Time frame: between baseline and 3 month
evaluation of device adherence at 1 month
Time frame: between baseline and 1 month
evaluation of device adherence at 3 month
Time frame: between baseline and 3 month
evaluation of device tolerance at 1 month
Time frame: between baseline and 1 month
evaluation of device tolerance at 3 month
Time frame: between baseline and 3 month
evaluation of device satisfaction at 1 month
Time frame: between baseline and 1 month
evaluation of device satisfaction at 3 month
Time frame: between baseline and 3 month
change from baseline vagal tone at 1 month
Time frame: between baseline and 1 month
change from baseline vagal tone at 3 month
Time frame: between baseline and 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Results publication: PubMed 39768526Tavares-Figueiredo I, Pers YM, Duflos C, Herman F, Sztajnzalc B, Lecoq H, Laffont I, Dupeyron AF, Homs AF. Effect of Transcutaneous Auricular Vagus Nerve Stimulation in Chronic Low Back Pain: A Pilot Study. J Clin Med. 2024 Dec 13;13(24):7601. doi: 10.3390/jcm13247601.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of an auricular electrode in people with Low Back Pain, run by University Hospital, Montpellier at 2 sites in France.
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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change from baseline pain at 1 month (time frame: between baseline and 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 NCT05639270, 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 12 Jun 2026.