Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients

Centre Hospitalier Universitaire de Nīmes15 enrolled

Overview

This study aims to evaluate neurofeedback-induced changes in brain function and the correlations between these changes and clinical scores by functional magnetic resonance imaging and electroencephalography in patients with low back pain.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Low Back Pain Chronic Low Back Pain

Interventions

Neurofeedback treatmentOTHER

20 sessions of neurofeedback of 5 minutes each consisting of : * The patient is equipped with an electroencephalography headset. The feedback visual has the form of a candle flame and is modulated by alpha synchrony. * The height of the flame is proportional to the intensity of the patient's pain. The patient has to concentrate on the height of this flame by thought to modulate it and, at the same time, to decrease the intensity of his own pain.

functional magnetic resonance imaging (fMRI) scansOTHER

The patient in alpha synchrony related state and in rating state will undergo an fMRI

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with a wifi connexion at home * Patient with the ability to modulate the height of the candle by thinking in the alpha synchrony test. * Patient with chronic low back pain for more than six months with a visual analogue pain scale greater than 5 impacting activities of daily living, hobbies and work * Patient having given free and informed consent and signed consent. * Affected patient or beneficiary of a health insurance plan. * Patient who is at least 18 years old (≥) and younger than 75 years old (\<). Exclusion Criteria: * Pregnant or breastfeeding patient * Patient with a contraindication to performing a fMRI scan: ferromagnetic implant in the body, piercing, claustrophobia, unable to remain in the scanner stationary for 40 minutes * Patient already included in another study * Patient in a exclusion period determined by a previous study * The subject is under the protection of justice, guardianship or curatorship. * The subject refuses to sign the consent. * It is not possible to give the subject informed information.

Locations (1)

Nimes University Hospital

Nîmes, France

Outcomes

Primary Outcomes

Description of the cortical zone activated by neurofeedback

Measure taken by electroencephalography

Time frame: Day 20

Secondary Outcomes

Back Beliefs Questionnaire (BBQ)

Auto-Questionnaire with 14 items describing the patient beliefs about chronic low back pain. The higher the score, the more the beliefs are negative

Time frame: Day 20

Fear Avoidance Beliefs Questionnaire (FABQ)

Auto-Questionnaire with 16 items describing apprehension and avoidance in relation to professional activities and physical activities.

Time frame: Day 20

Oswestry Disability Index (ODI)

Scale used to assess the functional disability of low back pain patients.

Time frame: Day 20

Coping Strategies Questionnaire (CSQ)

Auto-Questionnaire with 21 items evaluating coping strategies specific to pain and especially in low back pain

Time frame: Day 20

Hospital Anxiety and Depression Scale (HADS)

Auto-Questionnaire with 14 items used in the detection of anxio-depressive disorders. The higher the score, the more the depression is severe.

Time frame: Day 20

Scale of lumbar pain in Quebec

Autoquestionnaire with 20 items used to measure the functional repercussions of low back pain on simple actions of everyday life. The higher the score, the more low back pains have a significant functional impact.

Time frame: Day 20

Data from ClinicalTrials.gov

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