Clinical trial NCT04592094: Evaluation of Performances and Safety of the Medical Device Blueback® Physio for Patients With Chronic Low Back Pain
Official title: Evaluation of Performances and Safety of the Medical Device Blueback® Physio for Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain, Recurrent
Lead sponsor: Blueback
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
First posted: 2020-10-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time needed to master the motor control of the muscle (in number of rehabilitation sessions)
timeFrame: 5 weeks including 5 rehabilitation sessions per week
Secondary outcomes:
measure: Well-being for daily life based on a questionnaire
timeFrame: 5 weeks
measure: Well-being for daily life based on a muscular test
timeFrame: 5 weeks
measure: Pain feeling
timeFrame: 5 weeks
measure: Medical Device Safety
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Rennes
country: France
facility: Clinique FSEF Rennes BEAULIEU
Study officials:
affiliation: Centre Médical et Pédagogique de Beaulieu
name: Benjamin MARGO, MD
role: PRINCIPAL_INVESTIGATOR
References: