Assessment of the Safety and Performance of a Lumbar Belt

Low Back Pain Clinical Trial

Official title:

Assessment of the Safety and Performance of a Lumbar Belt

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552248
• Other study ID #: lumbarSOFT300-MID500
• Status: Recruiting
• Start date: September 23, 2022
• Est. completion date: December 2023

Study information

• Verified date: January 2023
• Source: Decathlon SE
• Contact: Jean HEE
• Phone: 07 64 35 00 45
• Email: jean.hee[@]btwin.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Low Back Pain

Intervention

Device:
• LumbarBelt SOFT 300
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.

Other:
• Control group LumbarBelt SOFT 300
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.

Device:
• LumbarBelt MID 500
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.

Other:
• Control group LumbarBelt MID 500
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.

Locations

Country	Name	City	State
France	Centre Hospitalier de Boulogne-sur-Mer	Boulogne-sur-Mer
France	Centre de rééducation et de balnéothérapie Kinés Faches	Faches-Thumesnil

Sponsors (2)

Lead Sponsor	Collaborator
Decathlon SE	EFOR, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline functionnal score at 12 weeks
Secondary	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	Change from Baseline confidence level at 12 weeks
Secondary	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	Change from Baseline low back pain at 12 weeks
Secondary	Safety (adverse events)	Comparison of adverse events rates between the groups (orthosis vs control), for each device model	12 weeks of follow-up