Prospective Evaluation of the Performance and Safety of the PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment of Locomotor Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Vivaltis
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Mean change in Lower Extremity Functional Scale (LEFS) score on the impact of locomotor disorders of the knee
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
结局指标
主要结局
Mean change in Lower Extremity Functional Scale (LEFS) score on the impact of locomotor disorders of the knee
时间窗: 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.
Mean change in the Oswestry Disability Index (ODI) score for the impact of locomotor disorders of the spine.
时间窗: At Day 0 and Week 11 (at the end visit within the week after the 12th seance)
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.
次要结局
- 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 of microcirculation of the concerned spine area(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))
- Changes of the microcirculation of the concerned knee area(At Day 0 and Week 11 (at the end visit within the week after the 12th seance))
- Changes of the improvement of the motor control through the measurement of myoelectrical 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 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 in awakening and muscle strengthening through measurement of myoelectric activity(At Day 0 and Week 11 (at the end visit within the week after the 12th seance))
- Change in patient's quality of life(At Day 0 and Week 11 (at the end visit within the week after the 12th seance))
- Pecentage of patients with an improvement in locomotor disorders(At Day 0 and Week 11 (at the end visit within the week after the 12th seance))
- Incidence of adverse events(At Day 0 and Week 11 (at the end visit within the week after the 12th seance))
- Evaluation of responses to the patient satisfaction questionnaire on the use of the PHENIX LIBERTY device after therapeutic management(At Day 0 and Week 11 (at the end visit within the week after the 12th seance))
- 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))