Low Back PainCONFORTNCT07355790
Evaluation of the Comfort Increase Provided by an Additional Foam Pad on a Lumbar Belt and Its Biophysical Impact
A study testing MRI, MRI evening 2 and MRI evening 1 in people with Low Back Pain and Healthy Volunteer, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The spine is the central musculoskeletal system of the back. It carries and supports a major part of the body weight and ensures simultaneously the trunk's mobility, particularly the mobility of the lumbar spine and the head's mobility by moving the cervical spine. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Healthy Volunteer
- What is being tested?
- MRI, MRI evening 2 and MRI evening 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2025to 5 Oct 2026
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer, men or women, aged 18 to 50 years old without lumbar pathology.
- Volunteer beneficiary of a social security scheme.
- Volunteer informed about the study and having co-signed a consent form to participate to the study with the investigator
Who cannot join
- Protected persons
- Pregnant or breastfeeding women
- Persons deprived of freedom, hospitalised without consent, hospitalised with other ends then research.
- Adults under legal protection (protection of vulnerable adults) or not able to express consent.
- Persons showing gait difficulties (test on treadmill) or with neurological/joint pathologies promoting falls (Parkinson, hemiplegia, …)
- Patient seen by a doctor for lumbar pain in the 2 months prior to the inclusion.
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- Patient suffering from scoliosis
- Refusal of consent
- Contraindication to MRI
- Patient carrying an internal electronic device (pacemaker, neurostimulator, insulin pump…)
- Patient with known allergies to one of the product components (e.g. latex)
- During the first MRI, volunteers showing prior signs of lower back pain or discopathy will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Comfort Increase Provided by an Additional Foam Pad on a Lumbar Belt "Cellacare Lumbal Classic - Lohmann & Rauscher" and Its Biophysical Impact
The spine is the central musculoskeletal system of the back. It carries and supports a major part of the body weight and ensures simultaneously the trunk's mobility, particularly the mobility of the lumbar spine and the head's mobility by moving the cervical spine. Back pain in the lumbar spine area is the most common kind of pain with a prevalence of 60 to 70 per cent in industrialized countries (Jellema2001).
Read the detailed description
Back orthosis permits temporary support and stress reduction (in terms of load) of the concerned structures and first of all intervertebral disks. The aim of this study is to evaluate the comfort variation with and without the additional back insert, with the hypothesis that a more comfortable lumbar belt would improve the care observance. This study also aims to verify the relevancy of objective indicators such as pressure measurement and disk hydration for the added benefice of the back insert.
- Conditions
- Low Back Pain, Healthy Volunteer
- Being tested
- MRI, MRI evening 2, MRI evening 1
- Keywords
- Lumbar belt, back insert, confort
- 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.
MRIDevice
MRI in the evening without lumbar belt
MRI evening 2Device
MRI in the evening after wearing the lumbar belt for one day
MRI evening 1Device
MRI in the evening after wearing the lumbar belt with additional back insert for one day
| Study group | Role | What they receive |
|---|---|---|
| Experimental group with additional back insert of a lumbar belt | Experimental | Additional back insert of a lumbar belt Receives: Device: MRI evening 1 |
| Control group with lumbar belt | Active comparator | a lumbar belt Receives: Device: MRI evening 2 |
| Control group without lumbar belt | Sham comparator | without lumbar belt Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
Comfort is measuring with a scale : 0 = uncomfortable, 10 = extremely comfortable
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start9 Dec 2025
- Primary completion9 Sep 2026
- Study completion5 Oct 2026
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 Saint EtienneThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Lohmann & Rauscher
- Responsible party
- Sponsor
- Investigators
- Hubert MAROTTE, MD PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355790
- Sponsor's protocol ID
- 25CH171
- Other IDs
- ANSM
- Acronym
- CONFORT
- Status last verified
- Oct 2026
- First submitted
- 27 Nov 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Comfort Increase Provided by an Additional Foam Pad on a Lumbar Belt "Cellacare Lumbal Classic - Lohmann & Rauscher" and Its Biophysical Impact
- ClinicalTrials.gov ID
- NCT07355790
- Acronym / sponsor ID
- CONFORT / 25CH171
- Conditions
- Low Back Pain, Healthy Volunteer
- Keywords
- Lumbar belt, back insert, confort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Lohmann & Rauscher
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 5 Oct 2026 (actual)
- First posted
- 21 Jan 2026 (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 spine is the central musculoskeletal system of the back. It carries and supports a major part of the body weight and ensures simultaneously the trunk's mobility, particularly the mobility of the lumbar spine and the head's mobility by moving the cervical spine. Back pain in the lumbar spine area is the most common kind of pain with a prevalence of 60 to 70 per cent in industrialized countries (Jellema2001).
Detailed description
Back orthosis permits temporary support and stress reduction (in terms of load) of the concerned structures and first of all intervertebral disks. The aim of this study is to evaluate the comfort variation with and without the additional back insert, with the hypothesis that a more comfortable lumbar belt would improve the care observance. This study also aims to verify the relevancy of objective indicators such as pressure measurement and disk hydration for the added benefice of the back insert.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group with additional back insert of a lumbar belt | Experimental | Device: MRI evening 1Additional back insert of a lumbar belt |
| Control group with lumbar belt | Active comparator | Device: MRI evening 2a lumbar belt |
| Control group without lumbar belt | Sham comparator | Device: MRIwithout lumbar belt |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteer, men or women, aged 18 to 50 years old without lumbar pathology.
- Volunteer beneficiary of a social security scheme.
- Volunteer informed about the study and having co-signed a consent form to participate to the study with the investigator
Key exclusion criteria (12 listed)
- Protected persons
- Pregnant or breastfeeding women
- Persons deprived of freedom, hospitalised without consent, hospitalised with other ends then research.
- Adults under legal protection (protection of vulnerable adults) or not able to express consent.
- Persons showing gait difficulties (test on treadmill) or with neurological/joint pathologies promoting falls (Parkinson, hemiplegia, …)
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 |
|---|---|---|
| MRIMRI in the evening without lumbar belt | Device | Control group without lumbar belt |
| MRI evening 2MRI in the evening after wearing the lumbar belt for one day | Device | Control group with lumbar belt |
| MRI evening 1MRI in the evening after wearing the lumbar belt with additional back insert for one day | Device | Experimental group with additional back insert of a lumbar belt |
Primary outcome
Comfort
Time frame: Day1
Comfort is measuring with a scale : 0 = uncomfortable, 10 = extremely comfortable
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 16 Oct 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. This study is not recruiting at the moment.
Hubert MAROTTE, MD PhD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI, MRI evening 2 and MRI evening 1 in people with Low Back Pain and Healthy Volunteer, run by Centre Hospitalier Universitaire de Saint Etienne 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 3 inclusion and 12 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 16 Oct 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. Some participants in this study may receive a placebo. 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?
Comfort (time frame: Day1). 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 16 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.