Evaluation of the Effect of Lumbar Belt on Spinal Mobility in Subjects With and Without Low Back Pain

Summary

Low back pain (LBP) is a common condition worldwide as the lifetime prevalence is up to 80%. It is defined as pain in the lumbosacral region in which the etiological causes are most often mechanical, and it is therefore defined as "non-specific LBP".

Lumbar belts are used in the treatment and secondary prevention of LBP. They are supposed to reduce the intensity of pain by improving the functional capacities of daily activities and thus preventing the risk of chronicity related to immobility (HAS).

Despite some proof of their efficiency in the literature, it is still not clear how the pressure applied by the belt and the immobilization constraints on the trunk improve the patient mobility.

Considering that LBP causes movement limitation, and that the lumbar belt contributes to initially decrease the pain intensity, as well as to improve the mobility and the functional capacities of the patient, we propose to evaluate the clinical and biomechanical effects of the lumbar belt during different trunk movements in subjects with and without LBP.

This is a clinical investigation on a CE marked medical device, used in accordance with its intended purpose, in the context of a post-marketing clinical follow-up with additional non-invasive procedures (IC SCAC: case 4.1 of the medical device regulation 2017/745).This is a prospective, monocentric, comparative and open clinical investigation.

The objective is to evaluate the clinical and functional effects related to spinal movements in 2 conditions, with and without the wearing of a lumbar belt. The study will be carried out with two groups of subjects: one group of subjects presenting an episode of LBP (NS\>4) (subjects considered to have subacute or chronic nonspecific LBP according to the classification of LBP) and another group of control subjects with no spinal symptoms and no pain that could limit movement (healthy subjects).

Each group will undergo 2 visits on 2 separate days with a 30-day delay for the LBP subjects and a 7-day delay for the healthy subjects

* a first visit (V1) for inclusion, familiarization with a clinical and functional test, and an external measurement of spinal mobility during movements;
* a second visit (V2) for a clinical and functional evaluation, external measurements of spinal mobility and biomechanical measurements.

A third visit (V3) will be offered to healthy subjects for the measurement of spinal segment kinematics with the LombaSkin belt and Percko postural T-shirt.

Conditions

• Low Back Pain

Interventions

DEVICE

Lumbar belt

All subjects (LBP group and healthy group) wear the belt during the two visits to perform differents tests. The invistigator will ask the LBP patients to wear the lumbar belt between the two visits (for 4 weeks, for 4 to 8 hours per day)

DEVICE

Lombaskin lumbar belt and the Lyne Up percko postural T-shirt.

Lombaskin lumbar belt and the Lyne Up percko postural T-shirt could be worn during the third addtional visit proposed to the healthy subject.

Sponsors & Collaborators

• Thuasne

  lead INDUSTRY

Principal Investigators

• Paul CALMELS, MD PhD · CHU SAINT-ETIENNE

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-30

Primary Completion

2024-03-29

Completion

2024-03-29

Countries

• France

Study Locations