Evaluation of the Performance of Blueback Physio® Medical Device in the Management of Patients Suffering from Chronic Low Back Pain: Randomized Clinical Trial

Abstract

Background

Chronic low back pain (CLBP) is one of the leading causes of disability in the world population. In 2017, in central Europe and North America, prevalence of CLBP was 12.51% and 9.80% respectively. The rehabilitation of the abdominal muscles, and notably the deep transversus abdominis, plays an important role in the management of CLBP in physiotherapy.

Objectives

The main objective of this study is to prove that a biofeedback device of the transversus abdominis, named Blueback Physio${}^{\circledR }$, developed by the Blueback company, improves the management of patients suffering from this pain.

Design

The clinical trial is designed as a prospective, monocentric, comparative, open-label randomized and parallel group study.

Method

41 subjects were included in this study and divided into two groups, one control group, in which the subjects used the device without visual biofeedback, and one intervention group, where the subjects used the complete biofeedback. The study included patients cared in day or full hospitalization in FSEF Rennes-Beaulieu Clinic, France, as part of the PRESDO program (“programme de prévention secondaire des dorso-lombalgies”).

Results

We found that patients who use visual biofeedback of the transverse abdominis muscle are more likely to (i) quickly learn to voluntarily contract this muscle and (ii) have better control of this muscle compared to patients who do not use it. Finally, the PRESDO program improves overall patient well-being.