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Completed

NCT Number: NCT06134999

Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation

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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Key information

Conditions

Knee Prosthesis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

José Carlos del Castillo Rodríguez

Santa Cruz de Tenerife, Santa Cruz De Tenerife, 38009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-invasive Neuromodulation

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

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.

Primary outcomes

  1. Change in Pain assessed by VAS

    Time frame: Baseline and up to four weeks

    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".

  2. Change in WOMAC questionnaire

    Time frame: Baseline and up to four weeks

    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.

  3. Change in the quality of life test

    Time frame: Baseline and up to four weeks

    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".

Sponsors and collaborators

Lead sponsor

University of Las Palmas de Gran Canaria

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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