- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05926739
Performance and Safety of the PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment of Musculoskeletal Disorders
Prospective Evaluation of the Performance and Safety of the PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment of Locomotor Disorders
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: George Billard
- Phone Number: 0467274889
- Email: georges.billard@vivaltis.com
Study Contact Backup
- Name: Camélia Bentaleb
- Email: camelia.bentaleb@ceiso.fr
Study Locations
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Nîmes, France, 30000
- Human Physio
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Study Population
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Standard of care plus additional questionaire
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 endof- life visit and validated questionnaires assessing functional deficiencies and impact on daily life.
|
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. The patient will undergo 12 therapeutic functional reeducation sessions, at regular intervals according to a schedule drawn up by the physiotherapist, during which the PHENIX LIBERTY device may be used. The patients will complete questionnaires at the end of the care. Overall, the functional rehabilitation sessions will include muscle testing, electrostimulation and biofeedback. The follow up will be conduct as follow :
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change in Lower Extremity Functional Scale (LEFS) score on the impact of locomotor disorders of the knee
Time Frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
|
The Lower Extremity Functional Scale (LEFS) is used by physiotherapists and occupational therapists in many clinical settings.
It is an English-language measurement tool that collects psychometric data and assesses the functional status of the lower limbs.
It consists of 20 questions on the level of difficulty experienced during everyday activities.
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At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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Mean change in the Oswestry Disability Index (ODI) score for the impact of locomotor disorders of the spine.
Time Frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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The ODI will be used to assess the disability caused by Lower Back Pain (LBP) The Oswestry Disability Index (ODI), a patient-completed questionnaire that gives a subjective percentage score of the level of function (disability) in activities of daily living in people undergoing rehabilitation after low back pain. The questionnaire examines the level of disability in 10 activities of daily living. Each item consists of 6 statements rated from 0 to 5. With 0 indicating the lowest level of disability and 5 the highest, the total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability. |
At Day 0 and Week 11 (at the end visit within the week after 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 at rest and on palpation
Time Frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
|
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 11 (at the end visit within the week after the 12th seance)
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Trends in consumption of painkillers and anti-inflammatories
Time Frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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Rate of consuption of painkillers and anti-inflammatories
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At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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Changes in the rate of improvement of hypertonia of the concerned area (knee or spine) through measurement of myoelectric activity
Time Frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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A surface Electromyography (EMG) will be used.
Muscle electrical activity provides a "map" of muscle recruitment according to exercise conditions (position, relative load, type of resistance, type of support, etc.).
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At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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Changes in the rate of improvement of hypertonia of the concerned area (knee or spine) through Oxford Grading Scale
Time Frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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The Oxford scale is commonly used to manually assess muscle strength, and can help diagnose problems in which weakness plays a role.
According to the Oxford scale, muscle strength is rated from 0 to 5 (0 being no muscle contraction > 5 being movement through a full range against full resistance).
Scoring is as follows: 0 → No visible or palpable contraction, 1 → Visible/palpable muscle contraction but no movement, 2 → Movement across full range with gravity eliminated (low strength), 3 → Movement across full range against gravity only (fair strength), 4 → Movement across full range against gravity with some resistance (good strength), 5 → Movement across full range against gravity with full resistance (normal strength).
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At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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Changes in the rate of improvement in awakening and muscle strengthening through Oxford grading scale
Time Frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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The Oxford scale is commonly used to manually assess muscle strength, and can help diagnose problems in which weakness plays a role.
According to the Oxford scale, muscle strength is rated from 0 to 5 (0 being no muscle contraction > 5 being movement through a full range against full resistance).
Scoring is as follows: 0 → No visible or palpable contraction, 1 → Visible/palpable muscle contraction but no movement, 2 → Movement across full range with gravity eliminated (low strength), 3 → Movement across full range against gravity only (fair strength), 4 → Movement across full range against gravity with some resistance (good strength), 5 → Movement across full range against gravity with full resistance (normal strength).
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At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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Changes in the rate of improvement in awakening and muscle strengthening through measurement of myoelectric activity
Time Frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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A surface Electromyography (EMG) will be used.
Muscle electrical activity provides a "map" of muscle recruitment according to exercise conditions (position, relative load, type of resistance, type of support, etc.).
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At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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Changes of microcirculation of the concerned spine area
Time Frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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Assessment on the basis of clinical palpation examination done by the practitioner
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At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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Changes of the microcirculation of the concerned knee area
Time Frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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The measurement of the muscular perimeter around the concerned knee will be assessed by a tape measure
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At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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Changes of the improvement of the motor control through the measurement of myoelectrical activity
Time Frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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A surface Electromyography (EMG) will be used.
Muscle electrical activity provides a "map" of muscle recruitment according to exercise conditions (position, relative load, type of resistance, type of support, etc.).
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At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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Change in patient's quality of life
Time Frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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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 11 (at the end visit within the week after the 12th seance)
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Pecentage of patients with an improvement in locomotor disorders
Time Frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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This outcome will be assessed according to the practitioner's opinion.
Does the practitioner think that an improvement has been observed --> Yes / No ?
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At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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Incidence of adverse events
Time Frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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Rate of the incidence of adverse events related to the medical device
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At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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Evaluation of responses to the patient satisfaction questionnaire on the use of the PHENIX LIBERTY device after therapeutic management
Time Frame: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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The satisfaction questionnaire is constructed on the basis of the Likert Scale.
The sponsor has written an questionnaire regarding the use of the Phenix Liberty for the patient.
The Likert scale (or attitude scale) is a semantic rating system, generally consisting of 5 or 7 items, used in surveys to measure and evaluate perceptions, attitudes and opinions.
The evaluation will be based on the following responses: Strongly agree (=5) ; Agree (=4) ; Rather agree (=3) ; Rather disagree (=2) ; Disagree (=1= ; Strongly disagree (=0).
The minimum score 0 means a worse outcome and the maximum score 5 means a better outcome.
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At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mathias Willame, Human Physio
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-A02460-45
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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