Assessment of the Safety and Performance of a Lumbar Belt

Decathlon

Status: Enrolling

Conditions: Low Back Pain

Treatments: Device: LumbarBelt SOFT 300; Other: Control group LumbarBelt MID 500; Other: Control group LumbarBelt SOFT 300; Device: LumbarBelt MID 500

Study type: Observational

Funder types: Industry

Identifiers

NCT05552248

lumbarSOFT300-MID500

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 4 patient groups

Orthosis group 1

Description:

Use of LumbarBelt Soft 300 device during sport practice (for 12 weeks)

Treatment:

Device: LumbarBelt SOFT 300

Control group 1

Description:

Control group of the LumbarBelt Soft 300 group - no medical device used during sport practice (for 12 weeks)

Treatment:

Other: Control group LumbarBelt SOFT 300

Orthosis group 2

Description:

Use of LumbarBelt Mid 500 device during sport practice (for 12 weeks)

Treatment:

Device: LumbarBelt MID 500

Control group 2

Description:

Control group of the LumbarBelt Mid 500 group - no medical device used during sport practice (for 12 weeks)

Treatment:

Other: Control group LumbarBelt MID 500