Assessment of the Safety and Performance of a Lumbar Belt

January 13, 2023 updated by: Decathlon SE

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Boulogne-sur-Mer, France, 62200
        • Recruiting
        • Centre Hospitalier de Boulogne-sur-mer
        • Contact:
        • Principal Investigator:
          • Yoann MORVAN
      • Faches-Thumesnil, France, 59155

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Orthosis group 1
Use of LumbarBelt Soft 300 device during sport practice (for 12 weeks)
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.
Control group 1
Control group of the LumbarBelt Soft 300 group - no medical device used during sport practice (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.
Orthosis group 2
Use of LumbarBelt Mid 500 device during sport practice (for 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.
Control group 2
Control group of the LumbarBelt Mid 500 group - no medical device used during sport practice (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functionnal score
Time Frame: Change from Baseline functionnal score at 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confidence level (confidence questionnaire related to physical activity)
Time Frame: Change from Baseline confidence level at 12 weeks
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
Low back pain
Time Frame: Change from Baseline low back pain at 12 weeks
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
Safety (adverse events)
Time Frame: 12 weeks of follow-up
Comparison of adverse events rates between the groups (orthosis vs control), for each device model
12 weeks of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Decathlon SE

Collaborators

EFOR, France

Investigators

  • Principal Investigator: Yoann MORVAN, Boulogne sur Mer Hospital Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 20, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lumbarSOFT300-MID500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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