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

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05207943
• Other study ID #: NESALCA
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: December 25, 2025

Study information

• Verified date: June 2024
• Source: University of Las Palmas de Gran Canaria
• Contact: Aníbal Báez Suárez, PhD
• Phone: 652077692
• Email: anibal.baez[@]ulpgc.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 25, 2025
• Est. primary completion date: September 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Wounds and Injuries

Intervention

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.
• 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

Locations

Country	Name	City	State
Spain	University of Las Palmas de Gran Canaria	Las Palmas de Gran Canaria	Las Palmas

Sponsors (1)

Lead Sponsor	Collaborator
University of Las Palmas de Gran Canaria

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Kakavas G, Malliaropoulos N, Bikos G, Pruna R, Valle X, Tsaklis P, Maffulli N. Periodization in Anterior Cruciate Ligament Rehabilitation: A Novel Framework. Med Princ Pract. 2021;30(2):101-108. doi: 10.1159/000511228. Epub 2020 Dec 2. — View Citation

Sanders TL, Maradit Kremers H, Bryan AJ, Larson DR, Dahm DL, Levy BA, Stuart MJ, Krych AJ. Incidence of Anterior Cruciate Ligament Tears and Reconstruction: A 21-Year Population-Based Study. Am J Sports Med. 2016 Jun;44(6):1502-7. doi: 10.1177/03635465166 — View Citation

Stewart BA, Momaya AM, Silverstein MD, Lintner D. The Cost-Effectiveness of Anterior Cruciate Ligament Reconstruction in Competitive Athletes. Am J Sports Med. 2017 Jan;45(1):23-33. doi: 10.1177/0363546516664719. Epub 2016 Sep 30. — View Citation

van Melick N, van Cingel RE, Brooijmans F, Neeter C, van Tienen T, Hullegie W, Nijhuis-van der Sanden MW. Evidence-based clinical practice update: practice guidelines for anterior cruciate ligament rehabilitation based on a systematic review and multidisc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee circumference	Centimeter measurement supra and infrapatellar with a tape measure with the leg in extension and without muscle contraction.	Up to 4 month
Primary	Motor Control	It will be assessed through a dop jump, vertical jump test and Single leg squat.	Up to 4 month
Primary	Functional ability	We will use the International Knee Documentation Committee (IKDC) questionnaire.	Up to 4 month
Primary	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)	Up to 4 month
Secondary	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.	Up to 4 month
Secondary	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	Up to 4 month
Secondary	Quality of life related to health	The SF-12 scale will be applied	Up to 4 month
Secondary	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	Up to 4 month