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