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Completed

NCT Number: NCT03929952

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

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.

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Key information

Conditions

Low Back Pain Back Pain Chronic Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nimes University Hospital

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

functional magnetic resonance imaging (fMRI) scans

Other

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

Primary outcomes

  1. Description of the cortical zone activated by neurofeedback

    Time frame: Day 20

    Measure taken by electroencephalography

Secondary outcomes

  1. Back Beliefs Questionnaire (BBQ)

    Time frame: 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

  2. Fear Avoidance Beliefs Questionnaire (FABQ)

    Time frame: Day 20

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

  3. Oswestry Disability Index (ODI)

    Time frame: Day 20

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

  4. Coping Strategies Questionnaire (CSQ)

    Time frame: Day 20

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

  5. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

  6. Scale of lumbar pain in Quebec

    Time frame: 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.

  7. Tampa scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: NEMOLOC

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2019
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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