Low Back PainMKI-TDMNCT06928740
Efficacy on Anxiety of the Digital Music Application Versus Equimolar Mixture of Oxygen and Nitrous Oxide in Patients Receiving CT-guided Lumbar Infiltration
A study testing Music Care® device and EMONO in people with Low Back Pain and Anxiety, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Since the Covid-19 crisis, patients appear more stressed, with increasing fear of exams and the hospital environment, in particular for CT scan teams, which require injections. Currently, an equimolar mixture of oxygen and nitrous oxide (EMONO) is used to calm patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Anxiety
- What is being tested?
- Music Care® device and EMONO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2025to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patients with low back pain for whom scan-guided infiltration is indicated, whether at the foraminal level, posterior joints, pudendal, epidural, sacroiliac, or via the sacrococcygeal hiatus.
- Patient with an anxiety score ≥ 35/100 based on the STAI-ETAT questionnaire
Who cannot join
- The subject is participating in another drug or category I interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Indication for epidural injection
- Patient who is deaf or hard of hearing
- Contraindications to EMONO
- Facial or head trauma making it impossible to wear a nasofacial mask or headphones
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nimes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Florelle TERRA
About this study
Official title: Evaluation de l'efficacité Sur l'anxiété de l'Application numérique Musicale, Music Care® Versus MEOPA, Kalinox® Chez Des Patients bénéficiant d'Une Infiltration Lombaire scanoguidée. Etude Monocentrique contrôlée randomisée de Non infériorité en Ouvert.
Since the Covid-19 crisis, patients appear more stressed, with increasing fear of exams and the hospital environment, in particular for CT scan teams, which require injections. Currently, an equimolar mixture of oxygen and nitrous oxide (EMONO) is used to calm patients. However, the patient's prone position complicates its use, with patients sometimes in painful position and the discomfort of gas inhalation (nausea, dizziness, etc.), as well as reduced lung capacity. Greater patient anxiety increases the risk of complications, or even failure, (unexpected movement, stiffness, refusal to complete the procedure, etc.). In this study, music therapy using Music Care® tablets, was tested to replace EMONO. The study authors hypothesize that the use of the Music Care® device will have a comparable efficacy to that of EMONO (non-inferiority) in reducing patient anxiety during CT-guided lumbar infiltration. Furthermore, the study authors hypothesize that this simple, non-invasive method, with no contraindications for the patient, will be better tolerated and appreciated by both the patient and the paramedical team in charge of the treatment.
- Conditions
- Low Back Pain, Anxiety
- Being tested
- Music Care® device, EMONO
- Keywords
- Music therapy, Computerized tomography scan, ENOMO, Radiographer
- Medical subject headings
- Low Back Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Care® deviceOther
Installation of the Music Care® device, selection of the sequence based on the patient's musical taste, listening to at least 20-minute sequence in the preparation room. Once placed on the scanner table, the patient listens to the same sequence as in the preparation room.
EMONOOther
Equimolar mixture of oxygen and nitrous oxide given as usual care
| Study group | Role | What they receive |
|---|---|---|
| Music Care | Experimental | Not described Receives: Other: Music Care® device |
| Control | Active comparator | Not described Receives: Other: EMONO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety between groups
0-100 visual analog scale (VSA)
Measured: Baseline
Anxiety between groups
0-100 visual analog scale (VSA)
Measured: Day 0: upon locating helix and a skin location
Anxiety between groups
0-100 visual analog scale (VSA)
Measured: Day 0: before injection of corticosteroids
Secondary outcomes (11)
Patient satisfaction between groups
0-100 visual analog scale (VSA)
Measured: Day 0: Before discharge from imagery department
Patient comfort between groups
0-100 visual analog scale (VSA)
Measured: Day 0: After injection of corticosteroids
Patient-reported pain between groups
0-100 visual analog scale (VSA)
Measured: Day 0: Before injection of corticosteroids
Patient-reported pain between groups
0-100 visual analog scale (VSA)
Measured: Day 0: After injection of corticosteroids
Anxiety between groups according to type of injection (foraminal, pudendal or posterior articular)
0-100 visual analog scale (VSA)
Measured: Day 0: Before injection of corticosteroids
Anxiety between groups according to type of injection (foraminal, pudendal or posterior, articular, epidural, sacroiliac joints, and sacrococcygeal hiatus)
0-100 visual analog scale (VSA)
Measured: Day 0: After injection of corticosteroids
Satisfaction of radiographer between groups
0-100 visual analog scale (VSA)
Measured: Day 0
Rate of adverse events between groups
According to Common Terminology Criteria for Adverse Events version 5.0 (grade 1-5)
Measured: Day 0: During procedure
Rate of adverse events between groups
According to Common Terminology Criteria for Adverse Events version 5.0 (grade 1-5)
Measured: Day 0: immediately after procedure
Rate of complications between groups
According to Clavien-Dindo (grade I-V)
Measured: Day 0: During procedure
Rate of complications between groups
According to Clavien-Dindo (grade I-V)
Measured: Day 0: immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start21 Oct 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2029 (estimated)
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florelle TERRA, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928740
- Sponsor's protocol ID
- NIMAO/2024-2/FT01
- Acronym
- MKI-TDM
- Status last verified
- Feb 2026
- First submitted
- 8 Apr 2025
- Last updated
- 20 Feb 2026
- 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 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation de l'efficacité Sur l'anxiété de l'Application numérique Musicale, Music Care® Versus MEOPA, Kalinox® Chez Des Patients bénéficiant d'Une Infiltration Lombaire scanoguidée. Etude Monocentrique contrôlée randomisée de Non infériorité en Ouvert.
- ClinicalTrials.gov ID
- NCT06928740
- Acronym / sponsor ID
- MKI-TDM / NIMAO/2024-2/FT01
- Conditions
- Low Back Pain, Anxiety
- Keywords
- Music therapy, Computerized tomography scan, ENOMO, Radiographer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 15 Apr 2025 (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.
Since the Covid-19 crisis, patients appear more stressed, with increasing fear of exams and the hospital environment, in particular for CT scan teams, which require injections. Currently, an equimolar mixture of oxygen and nitrous oxide (EMONO) is used to calm patients. However, the patient's prone position complicates its use, with patients sometimes in painful position and the discomfort of gas inhalation (nausea, dizziness, etc.), as well as reduced lung capacity. Greater patient anxiety increases the risk of complications, or even failure, (unexpected movement, stiffness, refusal to complete the procedure, etc.). In this study, music therapy using Music Care® tablets, was tested to replace EMONO. The study authors hypothesize that the use of the Music Care® device will have a comparable efficacy to that of EMONO (non-inferiority) in reducing patient anxiety during CT-guided lumbar infiltration. Furthermore, the study authors hypothesize that this simple, non-invasive method, with no contraindications for the patient, will be better tolerated and appreciated by both the patient and the paramedical team in charge of the treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Care | Experimental | Other: Music Care® device |
| Control | Active comparator | Other: EMONO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patients with low back pain for whom scan-guided infiltration is indicated, whether at the foraminal level, posterior joints, pudendal, epidural, sacroiliac, or via the sacrococcygeal hiatus.
- Patient with an anxiety score ≥ 35/100 based on the STAI-ETAT questionnaire
Key exclusion criteria (8 listed)
- The subject is participating in another drug or category I interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Indication for epidural injection
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 |
|---|---|---|
| Music Care® deviceInstallation of the Music Care® device, selection of the sequence based on the patient's musical taste, listening to at least 20-minute sequence in the preparation room. Once placed on the scanner table, the patient listens to the same sequence as in the preparation room. | Other | Music Care |
| EMONOEquimolar mixture of oxygen and nitrous oxide given as usual care | Other | Control |
Primary outcome
Anxiety between groups
Time frame: Baseline
0-100 visual analog scale (VSA)
Anxiety between groups
Time frame: Day 0: upon locating helix and a skin location
0-100 visual analog scale (VSA)
Anxiety between groups
Time frame: Day 0: before injection of corticosteroids
0-100 visual analog scale (VSA)
11 secondary outcomes
Patient satisfaction between groups
Time frame: Day 0: Before discharge from imagery department
Patient comfort between groups
Time frame: Day 0: After injection of corticosteroids
Patient-reported pain between groups
Time frame: Day 0: Before injection of corticosteroids
Patient-reported pain between groups
Time frame: Day 0: After injection of corticosteroids
Anxiety between groups according to type of injection (foraminal, pudendal or posterior articular)
Time frame: Day 0: Before injection of corticosteroids
Anxiety between groups according to type of injection (foraminal, pudendal or posterior, articular, epidural, sacroiliac joints, and sacrococcygeal hiatus)
Time frame: Day 0: After injection of corticosteroids
Satisfaction of radiographer between groups
Time frame: Day 0
Rate of adverse events between groups
Time frame: Day 0: During procedure
Rate of adverse events between groups
Time frame: Day 0: immediately after procedure
Rate of complications between groups
Time frame: Day 0: During procedure
Rate of complications between groups
Time frame: Day 0: immediately after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
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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.
Florelle TERRA principal investigator
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 Music Care® device and EMONO in people with Low Back Pain and Anxiety, 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 20 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florelle TERRA (06.37.59.77.34, florelle.terra@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety between groups (time frame: Baseline). The study lists 3 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 20 Feb 2026.