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NCT Number: NCT05207943

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

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.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Las Palmas de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location status: Recruiting

Location contact

Anibal Báez, Professor

CONTACT

[email protected]

+34652077692

Aníbal Báez Suárez, Professor

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Over 16 years old
  • In normal conditions and mentally competent to participate in the study.
  • Not having previous knee surgeries.
  • In condition to complete the study questionnaires.

Exclusion criteria

  • Present some of the contraindications for a treatment with NESA XSIGNAL®: pacemakers, internal bleeding, do not apply electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and / or electricity phobia.
  • Not having signed the informed consent.
  • Urgent surgical interventions.

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. Knee circumference

    Time frame: Up to 4 month

    Centimeter measurement supra and infrapatellar with a tape measure with the leg in extension and without muscle contraction.

  2. Motor Control

    Time frame: Up to 4 month

    It will be assessed through a dop jump, vertical jump test and Single leg squat.

  3. Functional ability

    Time frame: Up to 4 month

    We will use the International Knee Documentation Committee (IKDC) questionnaire.

  4. Level of Pain

    Time frame: Up to 4 month

    The Visual Analogue Scale (VAS) will be used to measure the perception of pain, which consists of a longitudinal line with 11 values ranging from 0 (none The Visual Analogue Scale (VAS) will be used to measure the perception of pain, which consists of a longitudinal line with 11 values ranging from 0 (no pain sensation) to 10 (maximum pain imaginable)

Secondary outcomes

  1. Range of motion

    Time frame: Up to 4 month

    To measure this variable, we will use a goniometer, which will align its fixed arm with the proximal segment of the limb, and the mobile arm with the distal segment, making its axis coincide with the axis of knee movement . 3 measurements will be carried out actively and another 3 passively, choosing the highest value obtained for each one. Flexion and extension movements will be analyzed.

  2. Brain activity

    Time frame: Up to 4 month

    Brain activity will be measured through an Electroencephalogram (EEG). Corresponds to a technique for studying the electrical activity of the brain through electrodes located on the scalp The parameters to be measured are the waves beta (13-30 Hz), which are produced when a subject is awake doing cognitive work and perceiving environmental stimulus

  3. Quality of life related to health

    Time frame: Up to 4 month

    The SF-12 scale will be applied

  4. Psychological perception test:

    Time frame: Up to 4 month

    TSK-11SV questionnaire (version adapted to Spanish). It is an 11-item questionnaire about fear of movement or injury. Patients have to indicate their degree of agreement with each of the statements presented, using a Likert-type scale from 1 (totally disagree) to 4 (totally agree). This questionnaire is designed to also assess the avoidance dimensions of activity and harm, but in this work we will only use the total score. High scores indicate greater fear of movement

Study contacts

Contact information is provided by the study sponsor or research team.

Aníbal Báez Suárez, PhD

CONTACT

[email protected]

652077692

Sponsors and collaborators

Lead sponsor

University of Las Palmas de Gran Canaria

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2022
Registry last updated
Aug 28, 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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