Low Back PainNCT05552248
Assessment of the Safety and Performance of a Lumbar Belt
An observational study of Low Back Pain, run by Decathlon SE at 2 sites in France.
Trial summary
Decathlon has developed the Lumbar belt Soft 300 and Mid 500 products which are medical devices designed to reduce pain and improve function during sport practice for athletes with a common subacute or chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- LumbarBelt SOFT 300 and LumbarBelt MID 500
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Sep 2022to Dec 2023
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject with medically-confirmed common subacute or chronic low back pain whose current condition of his/her back allows the subject to pursue a usual physical activity.
Who may be able to join
- Subject is aged ≥18 years old
- Subject has a medically-confirmed common subacute or chronic low back pain
- Subject performs regular physical activity
- The current condition of his/her back allows the subject to pursue a usual physical activity
- Subject has been informed and is willing to sign an informed consent form
- Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (12 weeks)
- Subject is affiliated to the French social security regime
Who cannot join
- Subject has undergone a surgical treatment for his/her back
- Subject presents associated neurologic signs (equina syndrome, radiculopathy, sciatica…)
- Subject presents signs of specific low back pain (i.e. low back pain is a symptom of an underlying condition): presence of red flags
- Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
- Subject has worn a support (lumbar or sacroiliac hip belt) during sports sessions in the last month
- Subject has any medical condition that could impact the study at investigator's discretion
- Subject has a known hypersensitivity or allergy to the components of the devices (elastodiene, elastane, polyamide, polyethersulfone [PES])
- Adult subject to a legal protection measure
Trial locations and contacts
2 sites in 1 country.
Sophie TALLON contact
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier de Boulogne-sur-Mer
Boulogne-sur-Mer, 62200
Yoann MORVAN, y.morvan@ch-boulogne.fr
Yoann MORVAN
- Recruiting
Centre de rééducation et de balnéothérapie Kinés Faches
Faches-Thumesnil, 59155
Loïc RAUSENBERGER, loic.rausenberger@groupefacheskines.com
Loïc RAUSENBERGER
About this study
Decathlon has developed the Lumbar belt Soft 300 and Mid 500 products which are medical devices designed to reduce pain and improve function during sport practice for athletes with a common subacute or chronic low back pain.
The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Lumbar belt range of products to demonstrate safety and performance of these devices in a real-world setting.
Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Decathlon lumbar belt Soft 300/ Mid 500 devices and support peer-reviewed publications on products performance and safety.
- Conditions
- Low Back Pain
- Being tested
- LumbarBelt SOFT 300, Control group LumbarBelt SOFT 300, LumbarBelt MID 500, Control group LumbarBelt MID 500
- 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.
LumbarBelt SOFT 300Device
15 patients will be included in this group and will used the medical device LumbarBelt SOFT 300 during sport practice (at least 2 sport sessions per week), for 12 weeks.
Control group LumbarBelt SOFT 300Other
15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device LumbarBelt SOFT 300), for at least 2 sport sessions per week during 12 weeks.
LumbarBelt MID 500Device
15 patients will be included in this group and will used the medical device LumbarBelt MID 500 during sport practice (at least 2 sport sessions per week), for 12 weeks.
Control group LumbarBelt MID 500Other
15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device LumbarBelt MID 500), for at least 2 sport sessions per week during 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Orthosis group 1 | Use of LumbarBelt Soft 300 device during sport practice (for 12 weeks) Receives: Device: LumbarBelt SOFT 300 | |
| Control group 1 | Control group of the LumbarBelt Soft 300 group - no medical device used during sport practice (for 12 weeks) Receives: Other: Control group LumbarBelt SOFT 300 | |
| Orthosis group 2 | Use of LumbarBelt Mid 500 device during sport practice (for 12 weeks) Receives: Device: LumbarBelt MID 500 | |
| Control group 2 | Control group of the LumbarBelt Mid 500 group - no medical device used during sport practice (for 12 weeks) Receives: Other: Control group LumbarBelt MID 500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functionnal score
Comparison of the Oswestry Disability Index (10-item questionnaire with a global score from 0=best outcome to 100=worst outcome) between the baseline and last follow-up visit in each group (orthosis vs control), for each device model
Measured: Change from Baseline functionnal score at 12 weeks
Secondary outcomes (3)
Confidence level (confidence questionnaire related to physical activity)
Gap in the confidence level related to physical activity (scale from 0=worst outcome to 100=best outcome), between the baseline and last follow-up visit in each group (orthosis vs control), for each device model
Measured: Change from Baseline confidence level at 12 weeks
Low back pain
Comparison of low back pain, assessed through a Numerical Rating Scale (NRS) ranging from 0=best outcome to 10=worst outcome, between the groups (orthosis vs control), for each device model
Measured: Change from Baseline low back pain at 12 weeks
Safety (adverse events)
Comparison of adverse events rates between the groups (orthosis vs control), for each device model
Measured: 12 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start23 Sep 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Decathlon SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EFOR, France
- Responsible party
- Sponsor
- Investigators
- Yoann MORVAN, Principal investigator, Boulogne sur Mer Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552248
- Sponsor's protocol ID
- lumbarSOFT300-MID500
- Status last verified
- Jan 2023
- First submitted
- 13 Sep 2022
- Last updated
- 17 Jan 2023
- 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 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Performance of a Lumbar Belt
- ClinicalTrials.gov ID
- NCT05552248
- Acronym / sponsor ID
- lumbarSOFT300-MID500
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Decathlon SEIndustry (pharma, biotech, devices)
- Collaborators
- EFOR, France
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Sep 2022 (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.
Decathlon has developed the Lumbar belt Soft 300 and Mid 500 products which are medical devices designed to reduce pain and improve function during sport practice for athletes with a common subacute or chronic low back pain.
The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Lumbar belt range of products to demonstrate safety and performance of these devices in a real-world setting.
Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Decathlon lumbar belt Soft 300/ Mid 500 devices and support peer-reviewed publications on products performance and safety.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Orthosis group 1 | – | Device: LumbarBelt SOFT 300Use of LumbarBelt Soft 300 device during sport practice (for 12 weeks) |
| Control group 1 | – | Other: Control group LumbarBelt SOFT 300Control group of the LumbarBelt Soft 300 group - no medical device used during sport practice (for 12 weeks) |
| Orthosis group 2 | – | Device: LumbarBelt MID 500Use of LumbarBelt Mid 500 device during sport practice (for 12 weeks) |
| Control group 2 | – | Other: Control group LumbarBelt MID 500Control group of the LumbarBelt Mid 500 group - no medical device used during sport practice (for 12 weeks) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject with medically-confirmed common subacute or chronic low back pain whose current condition of his/her back allows the subject to pursue a usual physical activity.
Key inclusion criteria (7 listed)
- Subject is aged ≥18 years old
- Subject has a medically-confirmed common subacute or chronic low back pain
- Subject performs regular physical activity
- The current condition of his/her back allows the subject to pursue a usual physical activity
- Subject has been informed and is willing to sign an informed consent form
Key exclusion criteria (8 listed)
- Subject has undergone a surgical treatment for his/her back
- Subject presents associated neurologic signs (equina syndrome, radiculopathy, sciatica…)
- Subject presents signs of specific low back pain (i.e. low back pain is a symptom of an underlying condition): presence of red flags
- Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
- Subject has worn a support (lumbar or sacroiliac hip belt) during sports sessions in the last month
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 |
|---|---|---|
| LumbarBelt SOFT 30015 patients will be included in this group and will used the medical device LumbarBelt SOFT 300 during sport practice (at least 2 sport sessions per week), for 12 weeks. | Device | Orthosis group 1 |
| Control group LumbarBelt SOFT 30015 patients will be included in this control group and will performed their sport sessions as usual (without the medical device LumbarBelt SOFT 300), for at least 2 sport sessions per week during 12 weeks. | Other | Control group 1 |
| LumbarBelt MID 50015 patients will be included in this group and will used the medical device LumbarBelt MID 500 during sport practice (at least 2 sport sessions per week), for 12 weeks. | Device | Orthosis group 2 |
| Control group LumbarBelt MID 50015 patients will be included in this control group and will performed their sport sessions as usual (without the medical device LumbarBelt MID 500), for at least 2 sport sessions per week during 12 weeks. | Other | Control group 2 |
Primary outcome
Functionnal score
Time frame: Change from Baseline functionnal score at 12 weeks
Comparison of the Oswestry Disability Index (10-item questionnaire with a global score from 0=best outcome to 100=worst outcome) between the baseline and last follow-up visit in each group (orthosis vs control), for each device model
3 secondary outcomes
Confidence level (confidence questionnaire related to physical activity)
Time frame: Change from Baseline confidence level at 12 weeks
Low back pain
Time frame: Change from Baseline low back pain at 12 weeks
Safety (adverse events)
Time frame: 12 weeks of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- 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.
Sophie TALLON contact
Yoann MORVAN principal investigator
Boulogne sur Mer Hospital Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Decathlon SE at 2 sites 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 7 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: status not confirmed, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean HEE (07 64 35 00 45 ext. +33, jean.hee@btwin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functionnal score (time frame: Change from Baseline functionnal score at 12 weeks). 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 17 Jan 2023.