Evaluation of Performances and Safety of the Medical Device Blueback® Physio for Patients With Chronic Low Back Pain

Study Overview
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Brief Summary
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The main objective of this clinical investigation is to show the superiority of a rehabilitation based on the use of Blueback® Physio compared to a rehabilitation without the use of Blueback® Physio in terms of reducing the time needed for a patient to control the voluntary contraction of the transversus abdominal muscle and to return to autonomy.

Detailed Description
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The Blueback® Physio is a wireless device for indicating, for a given patient, the relative level of contraction of the transversus abdominal muscle. Blueback® Physio is a CE marked class I medical device. This medical device allows to measure and visualize in real time the activity of the transversus abdominal muscle, one of the deepest muscle of the abdominal wall. It is placed on the patient, during a rehabilitation session with a mhysiotherapist. The objective is to optimize the three key phases followed by the healthcare professional: teaching his patient to feel the contraction of the muscle, learning to control this contraction, then learning to master this contraction when the patient is in double task (movements rehabilitation targeting other muscles, cognitive tasks or other tasks of everyday life that strain the spine). In the ABC-TRACC study, the objective is to compare the time needed for patient to get a good motor control on his transversus abdominal muscle if he is using the Blueback® Physio during his sessons or not.

Official Title
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Evaluation of Performances and Safety of the Medical Device Blueback® Physio for Patients With Chronic Low Back Pain

Conditions
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Low Back Pain, Recurrent

Intervention / Treatment
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* Device: Blueback® Physio


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Included in the PRESDO program, Suffering from chronic low back pain (= low back pain installed for more than 2 months), Beneficiary of a social security, For which his consent has been obtained in writing with regard to his participation in the protocol. Exclusion Criteria: Bedridden or using a wheelchair, Having a contraindication to performing the muscular exercises provided for in the protocol, Having any other condition which, in the opinion of healthcare professionals, could affect its ability to complete the study or could present a significant risk, Simultaneously participating in another clinical research protocol or having recently participated in another research for which the exclusion period has not been completed.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blueback® Physio<br>Classic protocole with the use of Blueback® Physio during physiotherapy sessions, , and using the Blueback® Physio in the active mode (patient and physiotherapists see the biofeedback in real time)during the tests required by the protocol of the study. | Device: Blueback® Physio<br>* Blueback® Physio is monitoring the activation level of the transversus abdominis muscle in real time during the exercises<br>|
| No Intervention: Standard Care<br>Classic protocole without the use of Blueback® Physio during physiotherapy sessions, and using the Blueback® Physio in the blind mode during the tests required by the protocol of the study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time needed to master the motor control of the muscle (in number of rehabilitation sessions) | The patient is mastering the motor control of the muscle on defined exercises with a quotation calculated using the Blueback Physio. The primary outcome measure is a composite between two tests mesauring the ability for the patient to control his mucle activity, and a third test to measure his autonomy on this control (does the patient has enough awarness of his own ability to control the muscle). The three tests are underwent using the Blueback Physio in order th get the quotations used for the calculations. | 5 weeks including 5 rehabilitation sessions per week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well-being for daily life based on a questionnaire | This secondary outcome will be assessed by using the NHP questionnaire. Each section of the questionnaire is rated between 0 and 100. A higher rate shows a lower well-being for the patient. | 5 weeks | 
| Well-being for daily life based on a muscular test | This secondary outcome will be assessed by using a muscular test (ito-shirado and sorensen). The tests consist in calculating the time during which the patient can maintain the requested posture. THe outcome is evaluated by calculating the ratio between the two tests. The closer to one (value 1) the better. | 5 weeks | 
| Pain feeling | This secondary criteria will be assessed using the NHP questionnaire. Each section of the questionnaire is rated between 0 and 100. A higher rate shows a lower well-being for the patient. | 5 weeks | 
| Medical Device Safety | The MD safety will be assessed by analysing the Undesirable side-effects and the Defects reported during the investigation | 5 weeks |