Evaluation of Performances and Safety of the Medical Device Blueback® Physio for Patients With Chronic Low Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Time needed to master the motor control of the muscle (in number of rehabilitation sessions)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Time needed to master the motor control of the muscle (in number of rehabilitation sessions)
Time Frame: 5 weeks including 5 rehabilitation sessions per week
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.
Secondary Outcomes
- Well-being for daily life based on a questionnaire(5 weeks)
- Well-being for daily life based on a muscular test(5 weeks)
- Pain feeling(5 weeks)
- Medical Device Safety(5 weeks)