Performance and Safety of the PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment of Musculoskeletal Disorders

NCT ID: NCT05926739

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-19
• Study Completion Date: 2024-12-18

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

Conditions

Musculoskeletal Disorder

Keywords

Electrical stimulation; Biofeedback; Knee; Low Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Electrical stimulation and biofeedback with Phenix Liberty medical device

Intervention Type: DEVICE

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 :

• 12 sessions between 6 and 8 weeks
• 1 end visit, within the week after the 12th session

Interventions

Electrical stimulation and biofeedback with Phenix Liberty medical device

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 :

• 12 sessions between 6 and 8 weeks
• 1 end visit, within the week after the 12th session

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CEISO

INDUSTRY

Sponsor Role: collaborator

Human Physio

UNKNOWN

Sponsor Role: collaborator

Vivaltis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathias Willame

Role: PRINCIPAL_INVESTIGATOR

Human Physio

Locations

Human Physio

Nîmes, , France

Countries

France

Other Identifiers

2023-A02460-45

Identifier Type: -

Identifier Source: org_study_id