NCT05207943

Efficacy of the NXSignal Device for the Treatment of Anterior Cruciate Ligament Injuries

Efficacy of the NXSignal Device for the Treatment of Anterior Cruciate Ligament Injuries. Randomized Controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Las Palmas de Gran Canaria · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

Injury to the anterior cruciate ligament (ACL) is very common among sports professionals and the general population \[. Unlike other joint injuries, it is reversible, but it can damage adjacent tissues, particularly the meniscus, and catalyze knee osteoarthritis. ACL injury produces instability, joint mechanical alteration, which can lead to degenerative joint diseases. The goal of treating the injury will be to prevent symptomatic instability, restore normal knee kinematics, and prevent degenerative joint disease . Its usual treatment is surgical and therefore contributes to a significant cost for the health system, both for the surgeries themselves, and for the rehabilitation and subsequent recovery processes. Within recovery therapies, in some cases, and given their popularity within the world of physiotherapy, electrotherapy techniques are proposed, primarily transcutaneous electrical nerve stimulation-type techniques with action on the muscular system and analgesia. An early intervention with neuromuscular electrostimulation electrotherapy (NMES) combined with repeated exercises is effective for the recovery of strength and restoration of the biomechanical symmetry of the limb. There is a diversity of opinions and disparate results regarding the use of this type of technique , in any case, it has been shown that electrical stimulation favors cell migration and joint tissue regeneration.

Detailed description

The design of this study is a randomised, triple blind clinical trial with placebo control. The general configuration of the study consists of capturing a group of patients treated with the same ACL surgical technique, operated on by the same surgeon, and including an additional treatment with the NESA XSIGNAL® device in a group of them. For this, a double-blind capture system will be available (neither users nor specialists responsible for recovery will know which patients enter the complementary treatment) and two NESA XSIGNAL® devices operating double-blind (due to the imperceptivity of the stimulation performed, there will be a placebo machine and another that applies the treatment). At the end of the study, the results obtained between the different groups of patients will be able to be compared; those additionally treated with a device, those treated with a placebo device and those in the standard rehabilitation procedure without a device.

Conditions

• Anterior Cruciate Ligament Injuries

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: 2021-05-25
• Primary completion: 2025-09-25
• Completion: 2025-12-25
• First posted: 2022-01-26
• Last updated: 2025-08-28

Locations

1 site across 1 country: Spain