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

Not Applicable

Completed

• Conditions: Chronic Low Back Pain; Low Back Pain
• Interventions: Other: Neurofeedback treatment; Other: functional magnetic resonance imaging (fMRI) scans

• Registration Number: NCT03929952
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-29
• Study Start: 2022-01-19
• Primary Completion: 2024-10-25
• Study Completion: 2024-10-25
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chronic low back pain	Neurofeedback treatment	-
Chronic low back pain	functional magnetic resonance imaging (fMRI) scans	-

Primary Outcome Measures

Name	Time	Method
Description of the cortical zone activated by neurofeedback	Day 20	Measure taken by electroencephalography

Secondary Outcome Measures

Name	Time	Method
Fear Avoidance Beliefs Questionnaire (FABQ)	Day 20	Auto-Questionnaire with 16 items describing apprehension and avoidance in relation to professional activities and physical activities.
Back Beliefs Questionnaire (BBQ)	Day 20	Auto-Questionnaire with 14 items describing the patient beliefs about chronic low back pain. The higher the score, the more the beliefs are negative
Oswestry Disability Index (ODI)	Day 20	Scale used to assess the functional disability of low back pain patients.
Hospital Anxiety and Depression Scale (HADS)	Day 20	Auto-Questionnaire with 14 items used in the detection of anxio-depressive disorders. The higher the score, the more the depression is severe.
Coping Strategies Questionnaire (CSQ)	Day 20	Auto-Questionnaire with 21 items evaluating coping strategies specific to pain and especially in low back pain
Scale of lumbar pain in Quebec	Day 20	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.
Tampa scale	Day 20	Autoquestionnaire 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.

Trial Locations

Locations (1)

Nimes University Hospital; 🇫🇷 Nîmes, France