Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients (NEMOLOC)
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|ClinicalTrials.gov Identifier: NCT03929952|
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : August 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain Chronic Low Back Pain||Other: Neurofeedback treatment Other: functional magnetic resonance imaging (fMRI) scans||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
|Experimental: Chronic low back pain||
Other: Neurofeedback treatment
20 sessions of neurofeedback of 5 minutes each consisting of :
Other: functional magnetic resonance imaging (fMRI) scans
The patient in alpha synchrony related state and in rating state will undergo an fMRI
- Description of the cortical zone activated by neurofeedback [ Time Frame: Day 20 ]Measure taken by electroencephalography
- 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
- 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.
- Oswestry Disability Index (ODI) [ Time Frame: Day 20 ]Scale used to assess the functional disability of low back pain patients.
- 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
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929952
|Contact: Arnaud Dupeyron||+33(0)firstname.lastname@example.org|
|Nimes University Hospital||Not yet recruiting|
|Nîmes, France, 30029|
|Contact: Anissa Megzari +33 (0)18.104.22.168.36 email@example.com|
|Principal Investigator: Arnaud Dupeyron, MD-PhD|
|Sub-Investigator: Fabricio Pereira, PhD|
|Sub-Investigator: Isabel Tavares, MD|
|Principal Investigator:||Arnaud Dupeyron, MD||Nîmes University Hospital|