Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-11

Study Completion Date

2025-07-31

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.

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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.

Conditions

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Knee Prosthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Non-invasive Neuromodulation

Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.

Group Type EXPERIMENTAL

Non-invasive Neuromodulation

Intervention Type DEVICE

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.

Placebo Non-invasive Neuromodulation

Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7.

Group Type PLACEBO_COMPARATOR

Placebo Non-invasive Neuromodulation

Intervention Type DEVICE

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.

Interventions

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Non-invasive Neuromodulation

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.

Intervention Type DEVICE

Placebo Non-invasive Neuromodulation

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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No