Pilot Study Before/After of Vagal Stimulation in Chronic Low Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 4
- Primary Endpoint
- change from baseline pain at 1 month
Study Overview
Brief 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 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: use of an auricular electrode (Device)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- evaluation of device adherence at 1 month(between baseline and 1 month)
- change from baseline anxiety and depression at 3 month(between baseline and 3 month)
- change from baseline catastrophism at 1 month(between baseline and 1 month)
- evolution of use of painkillers at 3 month(between baseline and 3 month)
- change from baseline functional disability at 1 month(between baseline and 1 month)
- change from baseline quality of life at 1 month(between baseline and 1 month)
- change from baseline quality of life at 3 month(between baseline and 3 month)
- change from baseline functional disability at 3 month(between baseline and 3 month)
- change from baseline catastrophism at 3 month(between baseline and 3 month)
- evaluation of device adherence at 3 month(between baseline and 3 month)
- evaluation of device tolerance at 1 month(between baseline and 1 month)
- evaluation of device tolerance at 3 month(between baseline and 3 month)
- evaluation of device satisfaction at 3 month(between baseline and 3 month)
- change from baseline anxiety and depression at 1 month(between baseline and 1 month)
- evolution of use of painkillers at 1 month(between baseline and 1 month)
- evaluation of device satisfaction at 1 month(between baseline and 1 month)
- change from baseline vagal tone at 1 month(between baseline and 1 month)
- change from baseline vagal tone at 3 month(between baseline and 3 month)