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

NCT04592094 | Completed

• 1 other identifier: 2020-A00651-38
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain, Recurrent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Well-being for daily life based on a questionnaire

  5 weeks

• Well-being for daily life based on a muscular test

  5 weeks

• Pain feeling

  5 weeks

• Medical Device Safety

  5 weeks

Study Arms (2)

Blueback® Physio

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

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

Interventions

Blueback® Physio DEVICE

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

Blueback® Physio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Blueback: lead
• Slb Pharma: collaborator

Study Sites (1)

Clinique FSEF Rennes BEAULIEU

Rennes, 35700, France

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Benjamin MARGO, MD

  Centre Médical et Pédagogique de Beaulieu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 19, 2020
• Study Start: November 16, 2020
• Primary Completion: December 7, 2022
• Study Completion: December 15, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)