NCT05600543: LombaMob

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

Completed NA Last updated 10 April 2025

What this trial tests

NA trial testing Lumbar belt in Low Back Pain in 28 participants. Completed in 29 March 2024.

Timeline

30 September 2022

Primary endpoint
29 March 2024

29 March 2024

Quick facts

Lead sponsor	Thuasne
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	30 September 2022
Primary completion	29 March 2024
Estimated completion	29 March 2024
Sites	1 location across France

Drugs / interventions tested

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

Conditions studied

• Low Back Pain — all drugs for Low Back Pain →

Sponsor

Thuasne

Who can join

Adults 18 to 70, any sex, with Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.