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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity of Las Palmas de Gran Canaria

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: Non-invasive NeuromodulationExperimental treatment 1 intervention
Group B: Placebo Non-invasive NeuromodulationSham comparator 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Knee circumference

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

Time frame
Up to 4 month
2

Motor Control

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

Time frame
Up to 4 month
3

Functional ability

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

Time frame
Up to 4 month
4

Level of Pain

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)

Time frame
Up to 4 month

Secondary outcomes

1

Range of motion

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.

Time frame
Up to 4 month
2

Brain activity

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

Time frame
Up to 4 month
3

Quality of life related to health

The SF-12 scale will be applied

Time frame
Up to 4 month
4

Psychological perception test:

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

Time frame
Up to 4 month

Other outcomes

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