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

NCT03929952 | Completed

• 2 other identifiers: NIMAO/2018-01/AD-012021-A00437-34
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Description of the cortical zone activated by neurofeedback

  Measure taken by electroencephalography

  Day 20

Secondary Outcomes (7)

• Back Beliefs Questionnaire (BBQ)

  Day 20

• Fear Avoidance Beliefs Questionnaire (FABQ)

  Day 20

• Oswestry Disability Index (ODI)

  Day 20

• Coping Strategies Questionnaire (CSQ)

  Day 20

• Hospital Anxiety and Depression Scale (HADS)

  Day 20

Study Arms (1)

Chronic low back pain

EXPERIMENTAL

Other: Neurofeedback treatment; Other: functional magnetic resonance imaging (fMRI) scans

Interventions

Neurofeedback treatment OTHER

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.

Chronic low back pain

functional magnetic resonance imaging (fMRI) scans OTHER

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

Chronic low back pain

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (\<).

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Nimes University Hospital

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnaud Dupeyron, MD

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: January 19, 2022
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

FR (1)