Pilot Study of Vagal Stimulation in Chronic Low Back Pain (VALOM)
Low Back Pain
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Vagus nerve stimulation, low back pain
Eligibility Criteria
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
Sites / Locations
- CHU MontpellierRecruiting
- CHU Nîmes - Le Grau du RoiRecruiting
Arms of the Study
Arm 1
Experimental
low back pain
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.