Low Back PainNGUYENNCT04007302
Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago
A study testing measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy), completion of questionnaires and completion of questionnaires for pain in people with Low Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The hypothesis of this work is that distraction is an effective way to modify the feeling and experience of chronic lumbar pain by modifying the functioning of the prefrontal cortex. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy), completion of questionnaires and completion of questionnaires for pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2018to 3 Nov 2018
- 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
- The patient must have given free and informed consent and signed the consent
- The patient must be a member or beneficiary of a health insurance plan
- The patient is available for a 3-day follow-up
- The patient is between 18 and 75 years old
- Disabling lumbar pain beyond three months
Who cannot join
- Subject participates in another intervention study
- Subject is in an exclusion period determined by a previous study
- The subject is under the protection of justice, guardianship or curatorship
- Subject refuses to sign consent
- It is impossible to provide informed information about the subject
- The subject is unable to complete the study questionnaires
Show all 22Show fewer
- The patient is pregnant, parturient, or breastfeeding
- The subject has a contraindication (or incompatible drug combination) for a treatment required for this study
- Recent involuntary weight loss
- Inflammatory schedule pain (predominantly nocturnal, requiring early morning rusting, improved by physical activity)
- Associated fever,
- Saddle anaesthesia
- Vesico-sphincterial disorders
- Typical root symptoms
- Systemic corticosteroid therapy
- History of cancer
- History of spinal trauma
- History of intravenous drug use
- Systemic corticosteroid therapy
- Surgical intervention of the spine or lower limbs
- Painful pathology of the lower limbs (coxarthrosis, gonarthrosis, vascular claudication or neurogenic when walking).
- ● Taking prescribed analgesic treatment after the inclusion procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modification de l'activité du Cortex préfrontal Induite Par Distraction en réalité Virtuelle Chez le Sujet Lombalgique Chronique.
The hypothesis of this work is that distraction is an effective way to modify the feeling and experience of chronic lumbar pain by modifying the functioning of the prefrontal cortex.
The main objective of this study is to show that during chronic low back pain generated during physical exercise, virtual reality distraction leads to the modification of the activity of the prefrontal cortex.
Read more
The secondary objectives are:
- Show a significant decrease in the average pain assessed with EVA during physical exercise with virtual reality distraction.
- Show an increase in the distance travelled with virtual reality distraction.
- Observe a decrease in perceived effort with virtual reality distraction.
- Quantify the adherence (presence) of subjects to the virtual environment
Read the detailed description
A pre-test phase at D0 will be carried out with the objective of individually determining the exercise conditions (speed and slope) of walking that will generate lumbar pain. Patients who have not experienced lumbar pain during this phase will be excluded from the study. The patients included are then randomized according to the order of physical exercise situations.
For the tests, patients will be equipped with a miniaturized wireless (Octamon, Artinis) and multi-channel (8 optodes) NIRS device placed on the patient's frontal lobe according to EEG 10-20 positioning (fig. 2). They will then be placed on an inclined treadmill according to the angle that caused the pain during the pre-test.
During the test, subjects will walk to the voluntary stop and the different reasons for the stop (feeling of fatigue, pain, etc.) will be recorded by visual analogue scales and questionnaires. The duration of the exercise will be measured by a digital stopwatch connected to the treadmill. During physical exercise, the bilateral activity of the prefrontal cortex will be recorded continuously at a sampling frequency of 10 Hz.
For each test, subjects will be confronted with 2 situations, on D1 and D2. In a situation, walking will be done without distraction. In the other situation, the patient will be placed in front of a screen with virtual reality simulation while performing the walking exercise.
- Conditions
- Low Back Pain
- Being tested
- measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy), completion of questionnaires, completion of questionnaires for pain
- 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.
measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy)Other
measurement of the cerebral oxygenation response by the use of the Near Infrared Spectroscopy (NIRS) method
completion of questionnairesOther
igroup presence questionnaire (IPQ), Dallas Pain Questionnaire (DRAD), Fear-Avoidance Beliefs (FABQ) and Quebec Back Lumbago Scale
completion of questionnaires for painOther
analogical visual and numerical scale and Borg scale
| Study group | Role | What they receive |
|---|---|---|
| walking with distraction | Experimental | the patient walks in front of a screen with virtual reality simulation Receives: Other: measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy); Other: completion of questionnaires; Other: completion of questionnaires for pain |
| Walking without distraction | Active comparator | the patient walks on a treadmill without virtual reality simulation Receives: Other: measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy); Other: completion of questionnaires; Other: completion of questionnaires for pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of prefrontal cortex activity
Brain oxygenation responses will be measured by the use of the Near Infrared Spectroscopy (NIRS) method (µmolar*cm)
Measured: Day 1
measurement of prefrontal cortex activity
Brain oxygenation responses will be measured by the use of the Near Infrared Spectroscopy (NIRS) method (µmolar*cm)
Measured: Day 2
Secondary outcomes (11)
assessment of average pain
analogical visual and numerical scale (0, no pain - 10 max pain)
Measured: Inclusion
assessment of average pain
analogical visual and numerical scale (0, no pain - 10 max pain)
Measured: Day 1
assessment of average pain
analogical visual and numerical scale (0, no pain - 10 max pain)
Measured: Day 2
measurement of the distance travelled
meters
Measured: Inclusion
measurement of the distance travelled
meters
Measured: Day 1
measurement of the distance travelleddistraction.
meters
Measured: Day 2
Observe a decrease in perceived effort with virtual reality distraction.
Borg's scale (0-10)
Measured: Inclusion
measurement of perceived effort
Borg's scale (0-10)
Measured: Day 1
measurement of perceived effort
Borg's scale (0-10)
Measured: Day 2
measurement of perceived effort
IPQ questionary (-3 ; +3)
Measured: Day 1
Quantify patients' adherence (presence) to the virtual environment
IPQ questionary (-3 ; +3)
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start9 Sep 2018
- Primary completion3 Nov 2018
- Study completion3 Nov 2018
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
- Randomised
- Intervention model
- Crossover
- 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
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007302
- Sponsor's protocol ID
- LOCAL 2017/DMNG-01
- Other IDs
- 2017-A02958-45
- Acronym
- NGUYEN
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification de l'activité du Cortex préfrontal Induite Par Distraction en réalité Virtuelle Chez le Sujet Lombalgique Chronique.
- ClinicalTrials.gov ID
- NCT04007302
- Acronym / sponsor ID
- NGUYEN / LOCAL 2017/DMNG-01
- Conditions
- 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
- 9 Sep 2018 (actual)
- Primary completion
- 3 Nov 2018 (actual)
- Study completion
- 3 Nov 2018 (actual)
- First posted
- 5 Jul 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.
The hypothesis of this work is that distraction is an effective way to modify the feeling and experience of chronic lumbar pain by modifying the functioning of the prefrontal cortex.
The main objective of this study is to show that during chronic low back pain generated during physical exercise, virtual reality distraction leads to the modification of the activity of the prefrontal cortex.
The secondary objectives are:
- Show a significant decrease in the average pain assessed with EVA during physical exercise with virtual reality distraction.
- Show an increase in the distance travelled with virtual reality distraction.
- Observe a decrease in perceived effort with virtual reality distraction.
- Quantify the adherence (presence) of subjects to the virtual environment
Detailed description
A pre-test phase at D0 will be carried out with the objective of individually determining the exercise conditions (speed and slope) of walking that will generate lumbar pain. Patients who have not experienced lumbar pain during this phase will be excluded from the study. The patients included are then randomized according to the order of physical exercise situations.
For the tests, patients will be equipped with a miniaturized wireless (Octamon, Artinis) and multi-channel (8 optodes) NIRS device placed on the patient's frontal lobe according to EEG 10-20 positioning (fig. 2). They will then be placed on an inclined treadmill according to the angle that caused the pain during the pre-test.
During the test, subjects will walk to the voluntary stop and the different reasons for the stop (feeling of fatigue, pain, etc.) will be recorded by visual analogue scales and questionnaires. The duration of the exercise will be measured by a digital stopwatch connected to the treadmill. During physical exercise, the bilateral activity of the prefrontal cortex will be recorded continuously at a sampling frequency of 10 Hz.
For each test, subjects will be confronted with 2 situations, on D1 and D2. In a situation, walking will be done without distraction. In the other situation, the patient will be placed in front of a screen with virtual reality simulation while performing the walking exercise.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| walking with distraction | Experimental | Other: measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy), Other: completion of questionnaires, Other: completion of questionnaires for painthe patient walks in front of a screen with virtual reality simulation |
| Walking without distraction | Active comparator | Other: measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy), Other: completion of questionnaires, Other: completion of questionnaires for painthe patient walks on a treadmill without virtual reality simulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient must have given free and informed consent and signed the consent
- The patient must be a member or beneficiary of a health insurance plan
- The patient is available for a 3-day follow-up
- The patient is between 18 and 75 years old
- Disabling lumbar pain beyond three months
Key exclusion criteria (22 listed)
- Subject participates in another intervention study
- Subject is in an exclusion period determined by a previous study
- The subject is under the protection of justice, guardianship or curatorship
- Subject refuses to sign consent
- It is impossible to provide informed information about the subject
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 |
|---|---|---|
| measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy)measurement of the cerebral oxygenation response by the use of the Near Infrared Spectroscopy (NIRS) method | Other | Walking without distraction, walking with distraction |
| completion of questionnairesigroup presence questionnaire (IPQ), Dallas Pain Questionnaire (DRAD), Fear-Avoidance Beliefs (FABQ) and Quebec Back Lumbago Scale | Other | Walking without distraction, walking with distraction |
| completion of questionnaires for painanalogical visual and numerical scale and Borg scale | Other | Walking without distraction, walking with distraction |
Primary outcome
measurement of prefrontal cortex activity
Time frame: Day 1
Brain oxygenation responses will be measured by the use of the Near Infrared Spectroscopy (NIRS) method (µmolar*cm)
measurement of prefrontal cortex activity
Time frame: Day 2
Brain oxygenation responses will be measured by the use of the Near Infrared Spectroscopy (NIRS) method (µmolar*cm)
11 secondary outcomes
assessment of average pain
Time frame: Inclusion
assessment of average pain
Time frame: Day 1
assessment of average pain
Time frame: Day 2
measurement of the distance travelled
Time frame: Inclusion
measurement of the distance travelled
Time frame: Day 1
measurement of the distance travelleddistraction.
Time frame: Day 2
Observe a decrease in perceived effort with virtual reality distraction.
Time frame: Inclusion
measurement of perceived effort
Time frame: Day 1
measurement of perceived effort
Time frame: Day 2
measurement of perceived effort
Time frame: Day 1
Quantify patients' adherence (presence) to the virtual environment
Time frame: Day 2
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 8 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy), completion of questionnaires and completion of questionnaires for pain in people with 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 5 inclusion and 22 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 8 Jul 2019. 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?
measurement of prefrontal cortex activity (time frame: Day 1). The study lists 2 primary outcomes in all. 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 8 Jul 2019.