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

NCT ID: NCT04592094

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-16
• Study Completion Date: 2022-12-15

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.

Conditions

Low Back Pain, Recurrent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Blueback® Physio

Intervention Type: DEVICE

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Blueback® Physio

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Slb Pharma

OTHER

Sponsor Role: collaborator

Blueback

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin MARGO, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Médical et Pédagogique de Beaulieu

Locations

Clinique FSEF Rennes BEAULIEU

Rennes, , France

Countries

France

Other Identifiers

2020-A00651-38

Identifier Type: -

Identifier Source: org_study_id