Clinical trial NCT05926739: Performance and Safety of the PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment of Musculoskeletal Disorders
Official title: Prospective Evaluation of the Performance and Safety of the PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment of Locomotor Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Disorder
Keywords: Electrical stimulation
Biofeedback
Knee
Low Back Pain
Lead sponsor: Vivaltis
Sponsor class: INDUSTRY
Collaborators: name: CEISO
name: Human Physio
First posted: 2023-07-03
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the evolution of locomotor abilities in patients treated with functional electrostimulation and biofeedback (PHENIX LIBERTY VIVALTIS device) for musculoskeletal disorders of the knee and spine.

Does the use of the medical device in the treatment of musculoskeletal disorders lead to an improvement ?

Participants will use the medical device, which provides electrical stimulation, biofeedback and pressure biofeedback to re-educate the muscles of the knee and spine area and

Detailed description: Rational :

Today, musculoskeletal disorders (MSDs) are considered to be one of the world's leading pathologies. They are also the most widespread occupational pathology in Europe. MSDs include a variety of conditions affecting bones, joints, muscles and connective tissues. To treat these disorders, the guidelines recommend non-drug therapies as first-line treatments for chronic low-back pain and osteoarthritis pain, such as electrostimulation and biofeedback therapy.

In this context, the promoter wishes to carry out this study in order to reinforce the data currently available on the medical device PHENIX LIBERTY.

Design:

Prospective, interventional with non invasive and non burdensome procedure, non-comparative, multicenter, open-label study of a CE-marked medical device

Intervention :

As part of this clinical investigation, the medical device under investigation is used in accordance with its usual use, and the patient's therapeutic procedure includes additional, non-invasive procedures. These additional procedures relate to the addition of an end-of-life visit and validated questionnaires assessing functional deficiencies and impact on daily life.

The care will be conduct as follow:

* 1 inclusion visit (V0) (from 1 say to 15 days prior the the first functionnal therapeutic re-education session)
* 12 sessions of functional therapeutic re-education, during which the PHENIX LIBERTY device may be used. Sessions performed at regular intervals according to a schedule drawn up by the physiotherapist (between 6 and 8 weeks);
* 1 end visit (V13), 1 week after the 12th session to complet questionnaires

In total, the patient will be followed 11 weeks maximum

Eligibility criteria: Inclusion Criteria:

* Adult patients (between 18 and 65 years of age);
* Patient presenting at least one of the following symptoms related to a locomotor disorder of the knee and/or spine: pain, hypertonia, amyotrophy, mobility restriction, muscle weakness, reduction or loss of motor control, reduction in motor pattern, trophic anomaly;
* Patient able to make himself available to attend sessions regularly and is confident of being able to complete all sessions; ;
* Patient who has signed the study participation consent form;y;
* Patient physically and mentally willing and able, according to the investigator's judgment at the time of recruitment, to perform the procedures under study;
* Patient with social security coverage.

Exclusion Criteria:

* Patients with Stroke, Alzheimer's, multiple sclerosis, peripheral nervous system disorders, spinal cord injury or with cognitive and/or behavioural disorders likely, in the practitioner's judgement in the practitioner's judgement, interact with the self-assessment or biofeedback;
* Patients with hypersensitivity to electrostimulation;
* Patients who, in the 1 month prior to inclusion, have had injections of corticosteroids (e.g. hyaluronate) in the knee/spine concerned;
* Patients with an implanted pacemaker or spinal cord pacemaker;
* Pregnant at the time of the inclusion visit, or wishing to become pregnant during the treatment period;
* Patients who have renounced their liberty by administrative or judicial sentence, or under guardianship or limited judicial protection;
* Patient participating in another interventional clinical trial for the same pathology or testing/having tested an investigational drug in the 30 days prior to inclusion in the study;
* Patient unable to read or write French;

Primary outcomes:
measure: Mean change in Lower Extremity Functional Scale (LEFS) score on the impact of locomotor disorders of the knee
timeFrame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
measure: Mean change in the Oswestry Disability Index (ODI) score for the impact of locomotor disorders of the spine.
timeFrame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Secondary outcomes:
measure: Change in patients' visual analog scale (VAS) pain scores for knee pain and/or spine pain at rest and on palpation
timeFrame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
measure: Trends in consumption of painkillers and anti-inflammatories
timeFrame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
measure: Changes in the rate of improvement of hypertonia of the concerned area (knee or spine) through measurement of myoelectric activity
timeFrame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
measure: Changes in the rate of improvement of hypertonia of the concerned area (knee or spine) through Oxford Grading Scale
timeFrame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
measure: Changes in the rate of improvement in awakening and muscle strengthening through Oxford grading scale
timeFrame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
measure: Changes in the rate of improvement in awakening and muscle strengthening through measurement of myoelectric activity
timeFrame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
measure: Changes of microcirculation of the concerned spine area
timeFrame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
measure: Changes of the microcirculation of the concerned knee area
timeFrame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
measure: Changes of the improvement of the motor control through the measurement of myoelectrical activity
timeFrame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
measure: Change in patient's quality of life
timeFrame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
measure: Pecentage of patients with an improvement in locomotor disorders
timeFrame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
measure: Incidence of adverse events
timeFrame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
measure: Evaluation of responses to the patient satisfaction questionnaire on the use of the PHENIX LIBERTY device after therapeutic management
timeFrame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Human Physio
Study officials:
affiliation: Human Physio
name: Mathias Willame
role: PRINCIPAL_INVESTIGATOR
References: