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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03929952
Acronym
NEMOLOC
Enrollment
15
Registered
2019-04-29
Start date
2022-01-19
Completion date
2024-10-25
Last updated
2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain, Low Back Pain

Brief summary

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.

Interventions

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.

OTHERfunctional magnetic resonance imaging (fMRI) scans

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

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Description of the cortical zone activated by neurofeedbackDay 20Measure taken by electroencephalography

Secondary

MeasureTime frameDescription
Back Beliefs Questionnaire (BBQ)Day 20Auto-Questionnaire with 14 items describing the patient beliefs about chronic low back pain. The higher the score, the more the beliefs are negative
Fear Avoidance Beliefs Questionnaire (FABQ)Day 20Auto-Questionnaire with 16 items describing apprehension and avoidance in relation to professional activities and physical activities.
Oswestry Disability Index (ODI)Day 20Scale used to assess the functional disability of low back pain patients.
Coping Strategies Questionnaire (CSQ)Day 20Auto-Questionnaire with 21 items evaluating coping strategies specific to pain and especially in low back pain
Scale of lumbar pain in QuebecDay 20Autoquestionnaire 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.
Tampa scaleDay 20Autoquestionnaire with 17 items used to estimate the level of kinesiophobia (fear and fear) related to pain that leads to avoidance of activities considered to cause or increase pain or to cause or aggravate an injury. The higher the score, the higher the level of kinesiophobia.
Hospital Anxiety and Depression Scale (HADS)Day 20Auto-Questionnaire with 14 items used in the detection of anxio-depressive disorders. The higher the score, the more the depression is severe.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026