Assessment of the Safety and Performance of a Lumbar Belt
1 other identifier
observational
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2022
CompletedFirst Posted
Study publicly available on registry
September 23, 2022
CompletedStudy Start
First participant enrolled
September 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJanuary 17, 2023
January 1, 2023
1.2 years
September 13, 2022
January 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Confidence level (confidence questionnaire related to physical activity)
Change from Baseline confidence level at 12 weeks
Low back pain
Change from Baseline low back pain at 12 weeks
Safety (adverse events)
12 weeks of follow-up
Study Arms (4)
Orthosis group 1
Use of LumbarBelt Soft 300 device during sport practice (for 12 weeks)
Control group 1
Control group of the LumbarBelt Soft 300 group - no medical device used during sport practice (for 12 weeks)
Orthosis group 2
Use of LumbarBelt Mid 500 device during sport practice (for 12 weeks)
Control group 2
Control group of the LumbarBelt Mid 500 group - no medical device used during sport practice (for 12 weeks)
Interventions
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.
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.
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.
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Decathlon SElead
- EFOR, Francecollaborator
Study Sites (2)
Centre Hospitalier de Boulogne-sur-Mer
Boulogne-sur-Mer, 62200, France
Centre de rééducation et de balnéothérapie Kinés Faches
Faches-Thumesnil, 59155, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yoann MORVAN
Boulogne sur Mer Hospital Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2022
First Posted
September 23, 2022
Study Start
September 23, 2022
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
January 17, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share