Low Back Pain, RecurrentABC-TRACCNCT04592094
Evaluation of Performances and Safety of the Medical Device Blueback® Physio for Patients With Chronic Low Back Pain
A study testing Blueback® Physio in people with Low Back Pain, Recurrent, run by Blueback at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Recurrent
- What is being tested?
- Blueback® Physio
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 16 Nov 2020to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Blueback® Physio
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueback® PhysioDevice
Blueback® Physio is monitoring the activation level of the transversus abdominis muscle in real time during the exercises
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks including 5 rehabilitation sessions per week
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 5 weeks
Medical Device Safety
The MD safety will be assessed by analysing the Undesirable side-effects and the Defects reported during the investigation
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start16 Nov 2020
- Primary completion7 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blueback
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Responsible party
- Sponsor
- Investigators
- Benjamin MARGO, MD, Principal investigator, Centre Médical et Pédagogique de Beaulieu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592094
- Sponsor's protocol ID
- 2020-A00651-38
- Acronym
- ABC-TRACC
- Status last verified
- Apr 2023
- First submitted
- 2 Oct 2020
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performances and Safety of the Medical Device Blueback® Physio for Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04592094
- Acronym / sponsor ID
- ABC-TRACC / 2020-A00651-38
- Conditions
- Low Back Pain, Recurrent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- BluebackIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blueback® Physio | Experimental | Device: Blueback® PhysioClassic 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blueback® PhysioBlueback® Physio is monitoring the activation level of the transversus abdominis muscle in real time during the exercises | Device | Blueback® Physio |
Primary outcome
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.
4 secondary outcomes
Well-being for daily life based on a questionnaire
Time frame: 5 weeks
Well-being for daily life based on a muscular test
Time frame: 5 weeks
Pain feeling
Time frame: 5 weeks
Medical Device Safety
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin MARGO, MD principal investigator
Centre Médical et Pédagogique de Beaulieu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueback® Physio in people with Low Back Pain, Recurrent, run by Blueback at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.