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Pilot Study of Vagal Stimulation in Chronic Low Back Pain (VALOM)

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
use of an auricular electrode
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Vagus nerve stimulation, low back pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

low back pain

Arm Description

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.

Outcomes

Primary Outcome Measures

change from baseline pain at 1 month
evaluated by a Visual Analog Scale (VAS, 0 the worst result and 100 the best result)

Secondary Outcome Measures

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
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
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)
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)
change from baseline anxiety and depression at 1 month
evaluated by HAD (Hospital Anxiety and Depression scale) score
change from baseline anxiety and depression at 3 month
evaluated by HAD (Hospital Anxiety and Depression scale) score
change from baseline catastrophism at 1 month
evaluated by PCS (Pain Catastrophizing Scale) score
change from baseline catastrophism at 3 month
evaluated by PCS (Pain Catastrophizing Scale) score
evolution of use of painkillers at 1 month
evolution of use of painkillers at 3 month
evaluation of device adherence at 1 month
number of stimulations performed
evaluation of device adherence at 3 month
number of stimulations performed
evaluation of device tolerance at 1 month
number of adverse events
evaluation of device tolerance at 3 month
number of adverse events
evaluation of device satisfaction at 1 month
Lickert scale from 1 to 5.
evaluation of device satisfaction at 3 month
Lickert scale from 1 to 5.
change from baseline vagal tone at 1 month
evaluated by Heart Rate variability
change from baseline vagal tone at 3 month
evaluated by Heart Rate variability

Full Information

First Posted
November 28, 2022
Last Updated
September 11, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT05639270
Brief Title
Pilot Study of Vagal Stimulation in Chronic Low Back Pain
Acronym
VALOM
Official Title
Pilot Study Before/After of Vagal Stimulation in Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Vagus nerve stimulation, low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low back pain
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
use of an auricular electrode
Intervention Description
Use of the auricular electrode throughout the duration of the study (30minutes/day) combined with assessment of pain, tolerance, vagal tone.
Primary Outcome Measure Information:
Title
change from baseline pain at 1 month
Description
evaluated by a Visual Analog Scale (VAS, 0 the worst result and 100 the best result)
Time Frame
between baseline and 1 month
Secondary Outcome Measure Information:
Title
change from baseline functional disability at 1 month
Description
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
Time Frame
between baseline and 1 month
Title
change from baseline functional disability at 3 month
Description
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
Time Frame
between baseline and 3 month
Title
change from baseline quality of life at 1 month
Description
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)
Time Frame
between baseline and 1 month
Title
change from baseline quality of life at 3 month
Description
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)
Time Frame
between baseline and 3 month
Title
change from baseline anxiety and depression at 1 month
Description
evaluated by HAD (Hospital Anxiety and Depression scale) score
Time Frame
between baseline and 1 month
Title
change from baseline anxiety and depression at 3 month
Description
evaluated by HAD (Hospital Anxiety and Depression scale) score
Time Frame
between baseline and 3 month
Title
change from baseline catastrophism at 1 month
Description
evaluated by PCS (Pain Catastrophizing Scale) score
Time Frame
between baseline and 1 month
Title
change from baseline catastrophism at 3 month
Description
evaluated by PCS (Pain Catastrophizing Scale) score
Time Frame
between baseline and 3 month
Title
evolution of use of painkillers at 1 month
Time Frame
between baseline and 1 month
Title
evolution of use of painkillers at 3 month
Time Frame
between baseline and 3 month
Title
evaluation of device adherence at 1 month
Description
number of stimulations performed
Time Frame
between baseline and 1 month
Title
evaluation of device adherence at 3 month
Description
number of stimulations performed
Time Frame
between baseline and 3 month
Title
evaluation of device tolerance at 1 month
Description
number of adverse events
Time Frame
between baseline and 1 month
Title
evaluation of device tolerance at 3 month
Description
number of adverse events
Time Frame
between baseline and 3 month
Title
evaluation of device satisfaction at 1 month
Description
Lickert scale from 1 to 5.
Time Frame
between baseline and 1 month
Title
evaluation of device satisfaction at 3 month
Description
Lickert scale from 1 to 5.
Time Frame
between baseline and 3 month
Title
change from baseline vagal tone at 1 month
Description
evaluated by Heart Rate variability
Time Frame
between baseline and 1 month
Title
change from baseline vagal tone at 3 month
Description
evaluated by Heart Rate variability
Time Frame
between baseline and 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabel TAVARES, MD
Phone
0467338717
Ext
+33
Email
i-tavaresfigueiredo@chu-montpellier.fr
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel TAVARES, MD
Phone
0467338717
Ext
+33
Email
i-tavaresfigueiredo@chu-montpellier.fr
Facility Name
CHU Nîmes - Le Grau du Roi
City
Nîmes
ZIP/Postal Code
30240
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ARNAUD DUPEYRON, PHD
Email
'arnaud.dupeyron@umontpellier.fr'

12. IPD Sharing Statement

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Pilot Study of Vagal Stimulation in Chronic Low Back Pain

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