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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Vivaltis · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2024-08-19
• Primary completion: 2024-12-18
• Completion: 2024-12-18
• First posted: 2023-07-03
• Last updated: 2024-12-24

Locations

1 site across 1 country: France