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

Musculoskeletal Disorder Clinical Trial

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

Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05926739
Study type Interventional
Source Vivaltis
Contact George Billard
Phone 0467274889
Email georges.billard@vivaltis.com
Status Not yet recruiting
Phase N/A
Start date May 30, 2024
Completion date December 19, 2024
View Details
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