Evaluation of Performances and Safety of the Medical Device Blueback® Physio for Patients With Chronic Low Back Pain (ABC-TRACC)

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain, Recurrent
• Intervention / Treatment: Device: Blueback® Physio

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline PAUTARD, PhD; Phone Number: 0033648031635; Email: cpautard@blueback.fr
• Study Contact Backup: Name: Clément JOUANNEAU, MS; Phone Number: 0033772326371; Email: cjouanneau@blueback.fr

Study Locations

• France
  • Rennes, France, 35700
    • Clinique FSEF Rennes BEAULIEU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blueback® Physio; Classic protocole with the use of Blueback® Physio during physiotherapy sessions, , and using the Blueback® Physio in the active mode (patient and physiotherapists see the biofeedback in real time)during the tests required by the protocol of the study.	Device: Blueback® Physio; Blueback® Physio is monitoring the activation level of the transversus abdominis muscle in real time during the exercises
No Intervention: Standard Care; Classic protocole without the use of Blueback® Physio during physiotherapy sessions, and using the Blueback® Physio in the blind mode during the tests required by the protocol of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time needed to master the motor control of the muscle (in number of rehabilitation sessions)	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.	5 weeks including 5 rehabilitation sessions per week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Well-being for daily life based on a questionnaire	This secondary outcome will be assessed by using the NHP questionnaire. Each section of the questionnaire is rated between 0 and 100. A higher rate shows a lower well-being for the patient.	5 weeks
Well-being for daily life based on a muscular test	This secondary outcome will be assessed by using a muscular test (ito-shirado and sorensen). The tests consist in calculating the time during which the patient can maintain the requested posture. THe outcome is evaluated by calculating the ratio between the two tests. The closer to one (value 1) the better.	5 weeks
Pain feeling	This secondary criteria will be assessed using the NHP questionnaire. Each section of the questionnaire is rated between 0 and 100. A higher rate shows a lower well-being for the patient.	5 weeks
Medical Device Safety	The MD safety will be assessed by analysing the Undesirable side-effects and the Defects reported during the investigation	5 weeks

Collaborators and Investigators

• Sponsor: Blueback
• Collaborators: Slb Pharma

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Actual): December 7, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2020-A00651-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No