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

Low Back Pain Clinical Trial

— NEMOLOC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03929952
• Other study ID #: NIMAO/2018-01/AD-01
• Secondary ID: 2021-A00437-34
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2022
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Arnaud Dupeyron
• Phone: +33(0)4.66.68.34.59
• Email: arnaud.dupeyron[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• Neurofeedback treatment
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
The patient in alpha synchrony related state and in rating state will undergo an fMRI

Locations

Country	Name	City	State
France	Nimes University Hospital	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the cortical zone activated by neurofeedback	Measure taken by electroencephalography	Day 20
Secondary	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	Day 20
Secondary	Fear Avoidance Beliefs Questionnaire (FABQ)	Auto-Questionnaire with 16 items describing apprehension and avoidance in relation to professional activities and physical activities.	Day 20
Secondary	Oswestry Disability Index (ODI)	Scale used to assess the functional disability of low back pain patients.	Day 20
Secondary	Coping Strategies Questionnaire (CSQ)	Auto-Questionnaire with 21 items evaluating coping strategies specific to pain and especially in low back pain	Day 20
Secondary	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.	Day 20
Secondary	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.	Day 20
Secondary	Tampa scale	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.	Day 20