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

Primary Purpose

Low Back Pain, Chronic Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neurofeedback treatment
functional magnetic resonance imaging (fMRI) scans
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Back Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nimes University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chronic low back pain

Arm Description

Outcomes

Primary Outcome Measures

Description of the cortical zone activated by neurofeedback
Measure taken by electroencephalography

Secondary Outcome Measures

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
Fear Avoidance Beliefs Questionnaire (FABQ)
Auto-Questionnaire with 16 items describing apprehension and avoidance in relation to professional activities and physical activities.
Oswestry Disability Index (ODI)
Scale used to assess the functional disability of low back pain patients.
Coping Strategies Questionnaire (CSQ)
Auto-Questionnaire with 21 items evaluating coping strategies specific to pain and especially in low back pain
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.
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.
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.

Full Information

First Posted
April 24, 2019
Last Updated
November 24, 2022
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT03929952
Brief Title
Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients
Acronym
NEMOLOC
Official Title
Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Chronic Low Back Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chronic low back pain
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Neurofeedback treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
functional magnetic resonance imaging (fMRI) scans
Intervention Description
The patient in alpha synchrony related state and in rating state will undergo an fMRI
Primary Outcome Measure Information:
Title
Description of the cortical zone activated by neurofeedback
Description
Measure taken by electroencephalography
Time Frame
Day 20
Secondary Outcome Measure Information:
Title
Back Beliefs Questionnaire (BBQ)
Description
Auto-Questionnaire with 14 items describing the patient beliefs about chronic low back pain. The higher the score, the more the beliefs are negative
Time Frame
Day 20
Title
Fear Avoidance Beliefs Questionnaire (FABQ)
Description
Auto-Questionnaire with 16 items describing apprehension and avoidance in relation to professional activities and physical activities.
Time Frame
Day 20
Title
Oswestry Disability Index (ODI)
Description
Scale used to assess the functional disability of low back pain patients.
Time Frame
Day 20
Title
Coping Strategies Questionnaire (CSQ)
Description
Auto-Questionnaire with 21 items evaluating coping strategies specific to pain and especially in low back pain
Time Frame
Day 20
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Auto-Questionnaire with 14 items used in the detection of anxio-depressive disorders. The higher the score, the more the depression is severe.
Time Frame
Day 20
Title
Scale of lumbar pain in Quebec
Description
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.
Time Frame
Day 20
Title
Tampa scale
Description
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.
Time Frame
Day 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud Dupeyron
Phone
+33(0)4.66.68.34.59
Email
arnaud.dupeyron@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Dupeyron, MD
Organizational Affiliation
Nîmes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nimes University Hospital
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari
Phone
+33 (0)4.66.68.42.36
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Arnaud Dupeyron, MD-PhD
First Name & Middle Initial & Last Name & Degree
Fabricio Pereira, PhD
First Name & Middle Initial & Last Name & Degree
Isabel Tavares, MD

12. IPD Sharing Statement

Learn more about this trial

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

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