Pilot Study of Vagal Stimulation in Chronic Low Back Pain
CompletedNot applicableNCT05639270
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Pilot Study Before/After of Vagal Stimulation in Chronic Low Back Pain
- Conditions
- Interventions
- Device: use of an auricular electrode
- Sponsor
- University Hospital, Montpellier
- Start date
- 2023-02-15
- Primary completion
- 2024-03-14
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05639270