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Assessment of the Safety and Performance of a Lumbar Belt

NCT05552248 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2023-01-17

No results posted yet for this study

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.

Conditions

  • Low Back Pain

Interventions

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.

Sponsors & Collaborators

  • EFOR, France

    collaborator INDUSTRY

  • Decathlon SE

    lead INDUSTRY

Principal Investigators

  • Yoann MORVAN · Boulogne sur Mer Hospital Center

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-23
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05552248 on ClinicalTrials.gov