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

Low Back Pain Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

• NCT number: NCT05600543
• Study type: Interventional
• Source: Thuasne
• Contact: Paul CALMELS, MD PhD
• Phone: (0)477120383
• Email: paul.calmels@chu-st-etienne.fr
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2022
• Completion date: August 31, 2023