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Completed

NCT Number: NCT04592094

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

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.

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Key information

Conditions

Low Back Pain, Recurrent Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique FSEF Rennes BEAULIEU

Rennes, 35700, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blueback® Physio

Device

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

Primary outcomes

  1. Time needed to master the motor control of the muscle (in number of rehabilitation sessions)

    Time frame: 5 weeks including 5 rehabilitation sessions per week

    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.

Secondary outcomes

  1. Well-being for daily life based on a questionnaire

    Time frame: 5 weeks

    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.

  2. Well-being for daily life based on a muscular test

    Time frame: 5 weeks

    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.

  3. Pain feeling

    Time frame: 5 weeks

    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.

  4. Medical Device Safety

    Time frame: 5 weeks

    The MD safety will be assessed by analysing the Undesirable side-effects and the Defects reported during the investigation

Sponsors and collaborators

Lead sponsor

Blueback

Industry

Collaborators

  • Slb Pharma

Registry information

Acronym: ABC-TRACC

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2020
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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