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

University of Las Palmas de Gran Canaria

Status: Enrolling

Conditions: Anterior Cruciate Ligament Injuries

Treatments: Device: Placebo Non-invasive Neuromodulation; Device: Non-invasive Neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05207943

NESALCA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 3 patient groups

Non-invasive Neuromodulation

Experimental group

Description:

Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level and and in the popliteal fossa.

Treatment:

Device: Non-invasive Neuromodulation

Placebo Non-invasive Neuromodulation

Sham Comparator group

Description:

Placebo microcurrents Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level and in the popliteal fossa.

Treatment:

Device: Placebo Non-invasive Neuromodulation

Control

No Intervention group

Description:

Participant will maintain the conventional rehabilitation treatment