NCT06134999

Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Las Palmas de Gran Canaria · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Knee Prosthesis

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2023-11-11
• Primary completion: 2025-05-13
• Completion: 2025-07-31
• First posted: 2023-11-18
• Last updated: 2025-08-22

Locations

1 site across 1 country: Spain