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NCT Number: NCT07355790

Evaluation of the Comfort Increase Provided by an Additional Foam Pad on a Lumbar Belt and Its Biophysical Impact

The spine is the central musculoskeletal system of the back. It carries and supports a major part of the body weight and ensures simultaneously the trunk's mobility, particularly the mobility of the lumbar spine and the head's mobility by moving the cervical spine. Back pain in the lumbar spine area is the most common kind of pain with a prevalence of 60 to 70 per cent in industrialized countries (Jellema2001).

Recruiting

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint Etienne

Saint-Etienne, 42100, France

Location status: Recruiting

Location contact

Hubert MAROTTE, PhD

CONTACT

[email protected]

About this study

Back orthosis permits temporary support and stress reduction (in terms of load) of the concerned structures and first of all intervertebral disks. The aim of this study is to evaluate the comfort variation with and without the additional back insert, with the hypothesis that a more comfortable lumbar belt would improve the care observance. This study also aims to verify the relevancy of objective indicators such as pressure measurement and disk hydration for the added benefice of the back insert.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteer, men or women, aged 18 to 50 years old without lumbar pathology.
  • Volunteer beneficiary of a social security scheme.
  • Volunteer informed about the study and having co-signed a consent form to participate to the study with the investigator

Exclusion criteria

  • Protected persons
  • Pregnant or breastfeeding women
  • Persons deprived of freedom, hospitalised without consent, hospitalised with other ends then research.
  • Adults under legal protection (protection of vulnerable adults) or not able to express consent.
  • Persons showing gait difficulties (test on treadmill) or with neurological/joint pathologies promoting falls (Parkinson, hemiplegia, …)
  • Patient seen by a doctor for lumbar pain in the 2 months prior to the inclusion.
  • Patient suffering from scoliosis
  • Refusal of consent
  • Contraindication to MRI
  • Patient carrying an internal electronic device (pacemaker, neurostimulator, insulin pump…)
  • Patient with known allergies to one of the product components (e.g. latex)
  • During the first MRI, volunteers showing prior signs of lower back pain or discopathy will be excluded.

Treatment and study plan

MRI

Device

MRI in the evening without lumbar belt

MRI evening 2

Device

MRI in the evening after wearing the lumbar belt for one day

MRI evening 1

Device

MRI in the evening after wearing the lumbar belt with additional back insert for one day

Primary outcomes

  1. Comfort

    Time frame: Day1

    Comfort is measuring with a scale : 0 = uncomfortable, 10 = extremely comfortable

Study contacts

Contact information is provided by the study sponsor or research team.

Florence RANCON, CDP

CONTACT

[email protected]

(0)477829458 ext. 33

Hubert MAROTTE, MD PhD

CONTACT

[email protected]

(0)477127639 ext. 33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Lohmann & Rauscher

Registry information

Official study title

Evaluation of the Comfort Increase Provided by an Additional Foam Pad on a Lumbar Belt "Cellacare Lumbal Classic - Lohmann & Rauscher" and Its Biophysical Impact

Acronym: CONFORT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 21, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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