NCT04592094

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Blueback · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain, Recurrent

Interventions

Type	Name	Description
DEVICE	Blueback® Physio	Blueback® Physio is monitoring the activation level of the transversus abdominis muscle in real time during the exercises

Timeline

• Start date: 2020-11-16
• Primary completion: 2022-12-07
• Completion: 2022-12-15
• First posted: 2020-10-19
• Last updated: 2023-04-12

Locations

1 site across 1 country: France