Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation

Study Overview
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Brief Summary
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It will consist of a randomized clinical trial with a control group. The sample will be distributed as homogeneously as possible into two groups, which will be randomly divided into a control group, to which the usual general treatment will be applied, and an experimental group, which will be treated with the NESA XSignal device. During the procedure, the subjects will continue to receive the usual care routine.

Detailed Description
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The main objective will be to evaluate the efficacy of the NESA XSignal device in relation to the improvement of pain, functionality and quality of life in patients who have undergone total knee replacement surgery.

Official Title
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Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation. PRONES Trial

Conditions
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Knee Prosthesis

Intervention / Treatment
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* Device: Non-invasive Neuromodulation
* Device: Placebo Non-invasive Neuromodulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years of age Total knee replacement surgery at the Hospital San Juan de Dios de Tenerife. Be able to freely consent to take part in the study. Exclusion Criteria: No contraindications for treatment with NXSignal: pacemakers, internal bleeding, poor skin condition with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or electricity phobia. Patients with total knee prosthesis of more than 3 months of evolution. Patients with total knee prosthesis with complications.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-invasive Neuromodulation<br>Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level. | Device: Non-invasive Neuromodulation<br>* The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 10 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7. Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 millivolt and intensity 0.5 μA.<br>|
| Placebo Comparator: Placebo Non-invasive Neuromodulation<br>Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7. | Device: Placebo Non-invasive Neuromodulation<br>* The same protocol described for the experimental group will be applied, but microcurrents device which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain assessed by VAS | The instrument will be used to measure the change of pain before and after the intervention will be the Visual Analogue Scale (VAS). Participants will be asked to mark the level of their pain on a 100 mm, no hatched VAS scale marked at one end as no pain and at the other as worst pain imaginable. | Baseline and up to four weeks | 
| Change in WOMAC questionnaire | The WOMAC ( Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire measures quality of life, in terms of Symptomatology and Physical Disability, in people with osteoarthrosis of the hip or knee. It contains 24 items grouped into 3 scales: pain (0-20), stiffness (0-8), functional capacity (0-68). The scales are used separately, they are not added together. Each item is answered with a 5-level verbal-type scale that is coded: None = 0; Little = 1; Quite a lot = 2; A lot = 3; Very much = 4. | Baseline and up to four weeks | 
| Change in the quality of life test | The EuroQol questionnaire will be used: a generic instrument for measuring health-related quality of life that can be used both in relatively healthy individuals (general population) and in groups of patients with different pathologies. The individual him/herself assesses his/her state of health, first in levels of severity by dimensions. The descriptive system contains five health dimensions (mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression) and each has three levels of severity (no problems, some problems or moderate problems, and severe problems). severity levels are coded 1 if the response option is no (I have) problems; 2 if the response option is some or moderate problems; and 3 if the response option is many problems. | Baseline and up to four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Replacement, physical therapy modality, Electric Stimulation, Transcutaneous