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

Study Overview
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Brief Summary
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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.

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Lumbar belt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for subjects Low Back Pain: Male or female, Aged between 18 and 70 years, With a waist circumference between 75 cm and 110 cm, With a 18.5 < BMI < 30 kg/m2, Suffering from a current episode of non-specific low back pain (symptomatic subjects), At least one average low back pain at rest or during exercise in the last 72 hours collected at inclusion (≥ 4/10 on an EN scale), Followed by a primary care physician or specialist for this clinical condition, Having received or scheduled to receive an EOS type radiological workup in less than 6 months Affiliated or entitled to a social security system, Having signed the written consent. Inclusion Criteria for healthy subjects: Male or female, Aged 18 to 70 years, With a waist circumference between 75 cm and 110 cm, With a 18.5 < BMI < 30 kg/m2, Never having suffered from LBP or any other type of lumbar disorder, Affiliated or entitled to a social security system, Having signed the written consent. Exclusion Criteria: Subjects suffering from LBP of inflammatory, tumoral or infectious cause. Pregnant women. Subjects with cognitive or mental disorders or confirmed depression; Subjects who received an infiltration less than one month prior to the inclusion visit or planned during the study; Subjects with a known allergy to any of the materials; Subjects complaining of chronic, unstabilized or symptomatic cardiac or respiratory problems; Subjects with current participation in an interventional investigational drug or device therapy study that impacts the endpoints. Subjects under legal protection or unable to express their consent; Subject presenting a lumbar radicular syndrome (hiatal hernia, spinal stenosis...).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Lumbar belt Lombastab® (Thuasne, Levallois Perret, France)<br>Low back pain patients wear Lumbar belt Lombastab® during 4 weeks according to the instructions given by the investigator of the study. | Device: Lumbar belt<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal Mobility assessed by the fingertip to floor distance test (FTF) | The effect of wearing a lumbar belt on spinal mobility during anterior flexion of the trunk (sagittal plane) in subjects with LBP using the fingertip to floor (FTF) distance test. | Immediately with and without wearing the lumbar belt (Day 0) | 
| Spinal Mobility assessed by the fingertip to floor distance test (FTF) | The effect of wearing a lumbar belt (for 4 weeks) on spinal mobility during anterior flexion of the trunk (sagittal plane) in subjects with LBP using the fingertip to floor (FTF) distance test. | After 4 weeks with and without wearing the lumbar belt (Day 30) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal Mobility assessed by the fingertip to floor distance test (FTF) | Spinal mobility (using the FTF test in forward flexion, the FTF test in lateral flexion and the sternum to wall test in extension): a.1) In subjects with LBP at Day 0 and Day 30 a.2) In healthy subjects (at Day 0) a.3) Between healthy subjects and LBP subjects (at Day 0) | During the Day 0 (for both groups) and Day 30 (for LBP patients) with and without wearing the belt | 
| Pain level assessed by Numerical Scale (NS) | Pain in LBP subjects (Day 0 vs Day 30) using Numerical Scale (NS) from 0 to 10 (0: no pain and 10: worst pain) | During the Day 0 and Day 30 immediately before and after wearing the belt, and after each movement with and without the belt (for LBP patients) | 
| Functional capacities assessed by Oswestry Disability Index (ODI) | Functional capacities of LBP subjects (Day 0 and Day 30) using Oswestry Disability Index (ODI) | During the beginning of Day 0 and Day 30 (for LBP patients) | 
| Kinematics of the spinal segments assessed by Inertial Measurement Units sensors | Kinematics of the spinal segments using 3 IMUs (Inertial Measurement Units) sensors: d.1) In LBP subjects (Day 0 vs Day 30) d.2) In healthy subjects (at Day 0) d.3) Between healthy subjects and LBP subjects (at Day 0) | During Day 0 (for both groups) and Day 30 (for LBP patients) with and without wearing the belt | 
| Trunk posture measured by 8-camera image stereo correlation system | Trunk posture using 8-camera image stereo-correlation system (Alternative to motion capture) e.1) In subjects with LBP (Day 30) e.2) In healthy subjects (at Day 7) e.3) Between healthy subjects and subjects with LBP (Day 7 vs Day 30) | During Day 7 (for healthy subjects) and Day 30 (for LBP patients) | 
| The pressure applied by the belt on the trunk assessed by piezo-resistive sensors | The pressure applied by the belt on the trunk using piezo-resistive sensors f.1) In subjects with LBP (Day 30) f.2) In healthy subjects (at Day 7) f.3) Between healthy subjects and LBP subjects (Day 7 vs Day 30) | During Day 7 (for healthy subjects) and Day 30 (for LBP patients) | 
| Deformation of the lumbar belt assessed by 8-camera image stereo-correlation system | To evaluate, during spinal movements, the deformation of the lumbar belt considered as a mechanism of action using 8-camera image stereo-correlation system: g.1) In LBP subjects (Day 30) g.2) In healthy subjects (Day 7) g.3) Between healthy subjects and LBP subjects (Day 7 vs Day 30) | During Day 7 (for healthy subjects) and Day 30 (for LBP patients) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Back Pain, Lumbar belt, Movement, Kinematics