Evaluation of the Efficacy of PHENIX LIBERTY, Electrical Stimulation and Biofeedback Medical Device, in the Treatment of Musculosqueletic Disorder

Study Overview
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Brief Summary
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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 improve urinary incontinence.

Detailed Description
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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 observational, non-comparative, single-center, open-label study of a CE-marked medical device. Intervention : This study is part of a routine observational study. As a result, management will not be modified. The intervention will be conduct as follow: 12 sessions of electrical stimulation and biofeedback performed between 6 and 8 weeks ; Sessions performed at regular intervals according to a schedule drawn up by the physiotherapist. The patients follow-up are up to 8 weeks after the first intervention.

Official Title
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Prospective Evaluation of the Efficacy of PHENIX LIBERTY, Electrical Stimulation and Biofeedback Medical Device, in the Treatment of Musculosqueletic Disorder

Conditions
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Musculoskeletal Disorder

Intervention / Treatment
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* Device: Electrical stimulation and biofeedback group


Participation Criteria
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Eligibility Criteria
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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 expecting to be able to complete the twelfth treatment session no later than 8 weeks after V0 ; Patient did not express non-opposition to participating in the study; 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 peripheral nervous system disorders or cognitive and/or behavioral problems which, in the practitioner's judgment, are likely to interact with evaluation by self-questionnaire or biofeedback; Patients with hypersensitivity to electrostimulation; Patients who, in the 3 months prior to inclusion, have had corticosteroid injections (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 who are under guardianship or limited judicial protection; Patient participating in another interventional clinical trial or testing/having tested an investigational drug within 30 days prior to inclusion in the study; Patient unable to read or write French; Patient refusing to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of care<br>Electrical stimulation and biofeedback by the medical device PHENIX LIBERTY | Device: Electrical stimulation and biofeedback group<br>* 12 sessions of electrical stimulation and biofeedback performed between 6 and 8 weeks at regular intervals according to a schedule drawn up by the physiotherapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the International Knee Documentation Committee score (IKDC) for the impact of locomotor disorders of the knee | The IKDC score will be used. It is a subjective knee evaluation questionnaire, developed by the IKDC (International Knee Documentation Committee), to assess symptoms and function during daily activities. It is divided into three sections (symptoms, sports activities, function) and gives a score between 0 (worst) and 100 (best). | At Day 0 and Week 8 (end of the 12th seance) | 
| Changes in the Oswestry Disability Index (ODI) score for the impact of locomotor disorders of the spine. | The ODI will be used to assess the disability caused by Lower Back Pain (LBP) The ODI is a self-administered questionnaire that requires 5 minutes to complete and 1 minute to score. Scores are associated with degree of disability ranging from minimal to bedbound. | At Day 0 and Week 8 (end of the 12th seance) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patients' visual analog scale (VAS) pain scores for knee pain and/or spine pain | The pain caused by the TMS of the knee and/or the spine will be assessed by the Visual Analogue Scale (VAS). The VAS is made up of a 10-centimeter line anchored by two ends of the pain. 10 is the first end being the maximum pain imaginable and 0 is the other end being no pain | At Day 0 and Week 8 (end of the 12th seance) | 
| Changes of the joint amplitude score to assess the hypertonia of the area | A goniometer will be used. A goniometer is a device that measures an angle. | At Day 0 and Week 8 (end of the 12th seance) | 
| Changes in the rate of improvement in awakening and muscle strengthening | The Oxford Gradient will be used. It permit the assessment of muscle strength by the practitioner, using palpation | At Day 0 and Week 8 (end of the 12th seance) | 
| Evolution of microcirculation of the area | Assessment on the basis of clinical palpation examination done by the practitioner | At Day 0 and Week 8 (end of the 12th seance) | 
| Change in patient's quality of life | The SF-36 will be used to assess the quality of life score. The SF-36, as described in the name, is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state. | At Day 0 and Week 8 (end of the 12th seance) | 
| Pecentage of patients with an improvement in locomotor disorders | This outcome will be assessed according to the practitioner's opinion | At Day 0 and Week 8 (end of the 12th seance) | 
| Incidence of adverse events | Rate of the incidence of adverse events related to the medical device | From Day 0 to Week 8 (end of the 12th seance) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical stimulation, Biofeedback, Knee, Low Back Pain