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

Low Back Pain, Recurrent Clinical Trial

— ABC-TRACC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04592094
• Other study ID #: 2020-A00651-38
• Status: Completed
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: December 15, 2022

Study information

• Verified date: April 2023
• Source: Blueback
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 15, 2022
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Recurrent

Intervention

Device:
• Blueback® Physio
Blueback® Physio is monitoring the activation level of the transversus abdominis muscle in real time during the exercises

Locations

Country	Name	City	State
France	Clinique FSEF Rennes BEAULIEU	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
Blueback	Slb Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Medical Device Safety	The MD safety will be assessed by analysing the Undesirable side-effects and the Defects reported during the investigation	5 weeks