Low Back PainNEMOLOCNCT03929952
Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients
A study testing Neurofeedback treatment and functional magnetic resonance imaging (fMRI) scans in people with Low Back Pain and Chronic Low Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain, Chronic Low Back Pain
- What is being tested?
- Neurofeedback treatment and functional magnetic resonance imaging (fMRI) scans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2022to 25 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (<).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Low Back Pain, Chronic Low Back Pain
- Being tested
- Neurofeedback treatment, functional magnetic resonance imaging (fMRI) scans
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback treatmentOther
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) scansOther
The patient in alpha synchrony related state and in rating state will undergo an fMRI
| Study group | Role | What they receive |
|---|---|---|
| Chronic low back pain | Experimental | Not described Receives: Other: Neurofeedback treatment; Other: functional magnetic resonance imaging (fMRI) scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the cortical zone activated by neurofeedback
Measure taken by electroencephalography
Measured: Day 20
Secondary outcomes (7)
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
Measured: Day 20
Fear Avoidance Beliefs Questionnaire (FABQ)
Auto-Questionnaire with 16 items describing apprehension and avoidance in relation to professional activities and physical activities.
Measured: Day 20
Oswestry Disability Index (ODI)
Scale used to assess the functional disability of low back pain patients.
Measured: Day 20
Coping Strategies Questionnaire (CSQ)
Auto-Questionnaire with 21 items evaluating coping strategies specific to pain and especially in low back pain
Measured: Day 20
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.
Measured: Day 20
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.
Measured: Day 20
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.
Measured: Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start19 Jan 2022
- Primary completion25 Oct 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Dupeyron, MD, Principal investigator, Nîmes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929952
- Sponsor's protocol ID
- NIMAO/2018-01/AD-01
- Other IDs
- 2021-A00437-34
- Acronym
- NEMOLOC
- Status last verified
- Jan 2025
- First submitted
- 24 Apr 2019
- Last updated
- 7 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT03929952
- Acronym / sponsor ID
- NEMOLOC / NIMAO/2018-01/AD-01
- Conditions
- Low Back Pain, Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic low back pain | Experimental | Other: Neurofeedback treatment, Other: functional magnetic resonance imaging (fMRI) scans |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofeedback treatment20 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. | Other | Chronic low back pain |
| functional magnetic resonance imaging (fMRI) scansThe patient in alpha synchrony related state and in rating state will undergo an fMRI | Other | Chronic low back pain |
Primary outcome
Description of the cortical zone activated by neurofeedback
Time frame: Day 20
Measure taken by electroencephalography
7 secondary outcomes
Back Beliefs Questionnaire (BBQ)
Time frame: Day 20
Fear Avoidance Beliefs Questionnaire (FABQ)
Time frame: Day 20
Oswestry Disability Index (ODI)
Time frame: Day 20
Coping Strategies Questionnaire (CSQ)
Time frame: Day 20
Hospital Anxiety and Depression Scale (HADS)
Time frame: Day 20
Scale of lumbar pain in Quebec
Time frame: Day 20
Tampa scale
Time frame: Day 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud Dupeyron, MD principal investigator
Nîmes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback treatment and functional magnetic resonance imaging (fMRI) scans in people with Low Back Pain and Chronic Low Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the cortical zone activated by neurofeedback (time frame: Day 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.