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

NCT05926739 | Completed

• 1 other identifier: 2023-A02460-45
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Musculoskeletal Disorder

Keywords

Electrical stimulation; Biofeedback; Knee; Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Mean change in Lower Extremity Functional Scale (LEFS) score on the impact of locomotor disorders of the knee

  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.

  At Day 0 and Week 11 (at the end visit within the week after the 12th seance)

• Mean change 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 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 Outcomes (13)

• Change in patients' visual analog scale (VAS) pain scores for knee pain and/or spine pain at rest and on palpation

  At Day 0 and Week 11 (at the end visit within the week after the 12th seance)

• Trends in consumption of painkillers and anti-inflammatories

  At Day 0 and Week 11 (at the end visit within the week after the 12th seance)

• Changes in the rate of improvement of hypertonia of the concerned area (knee or spine) through measurement of myoelectric activity

  At Day 0 and Week 11 (at the end visit within the week after the 12th seance)

• Changes in the rate of improvement of hypertonia of the concerned area (knee or spine) through Oxford Grading Scale

  At Day 0 and Week 11 (at the end visit within the week after the 12th seance)

• Changes in the rate of improvement in awakening and muscle strengthening through Oxford grading scale

  At Day 0 and Week 11 (at the end visit within the week after the 12th seance)

Study Arms (1)

Standard of care plus additional questionaire

OTHER

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.

Device: Electrical stimulation and biofeedback with Phenix Liberty medical device

Interventions

Electrical stimulation and biofeedback with Phenix Liberty medical device 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

Standard of care plus additional questionaire

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 with an implanted pacemaker or spinal cord pacemaker;
• Patients who have renounced their liberty by administrative or judicial sentence, or under guardianship or limited judicial protection;
• Patient unable to read or write French;

Sponsors & Collaborators

• Vivaltis: lead
• CEISO: collaborator
• Human Physio: collaborator

Study Sites (1)

Human Physio

Nîmes, 30000, France

Location

MeSH Terms

Conditions

Musculoskeletal Diseases; Low Back Pain

Interventions

Electric Stimulation; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Mathias Willame

  Human Physio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: August 19, 2024
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Locations

FR (1)