Clinical trial NCT05552248: Assessment of the Safety and Performance of a Lumbar Belt
Official title: Assessment of the Safety and Performance of a Lumbar Belt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Lead sponsor: Decathlon SE
Sponsor class: INDUSTRY
Collaborators: name: EFOR, France
First posted: 2022-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Functionnal score
timeFrame: Change from Baseline functionnal score at 12 weeks
Secondary outcomes:
measure: Confidence level (confidence questionnaire related to physical activity)
timeFrame: Change from Baseline confidence level at 12 weeks
measure: Low back pain
timeFrame: Change from Baseline low back pain at 12 weeks
measure: Safety (adverse events)
timeFrame: 12 weeks of follow-up
Other outcomes:
Locations:
city: Boulogne-sur-Mer
country: France
facility: Centre Hospitalier de Boulogne-sur-Mer
city: Faches-Thumesnil
country: France
facility: Centre de rééducation et de balnéothérapie Kinés Faches
Study officials:
affiliation: Boulogne sur Mer Hospital Center
name: Yoann MORVAN
role: PRINCIPAL_INVESTIGATOR
References: