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

NCT05207943 | Recruiting

• 1 other identifier: NESALCA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anterior Cruciate Ligament Injuries

Keywords

physical therapy modality; Electric Stimulation Therapy; Anterior Cruciate Ligament

Outcome Measures

Primary Outcomes (4)

• Knee circumference

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

  Up to 4 month

• Motor Control

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

  Up to 4 month

• Functional ability

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

  Up to 4 month

• 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 Outcomes (4)

• Range of motion

  Up to 4 month

• Brain activity

  Up to 4 month

• Quality of life related to health

  Up to 4 month

• Psychological perception test:

  Up to 4 month

Study Arms (3)

Non-invasive Neuromodulation

EXPERIMENTAL

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

Device: Non-invasive Neuromodulation

Placebo Non-invasive Neuromodulation

SHAM COMPARATOR

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

Device: Placebo Non-invasive Neuromodulation

Control

NO INTERVENTION

Participant will maintain the conventional rehabilitation treatment

Interventions

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.

Non-invasive Neuromodulation

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

Placebo Non-invasive Neuromodulation

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Las Palmas de Gran Canaria: lead

Study Sites (1)

University of Las Palmas de Gran Canaria

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

RECRUITING

Related Publications (4)

• 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: 10.1177/0363546516629944. Epub 2016 Feb 26.

  PMID: 26920430 RESULT

• 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.

  PMID: 27590175 RESULT

• 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.

  PMID: 33264774 RESULT

• 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 multidisciplinary consensus. Br J Sports Med. 2016 Dec;50(24):1506-1515. doi: 10.1136/bjsports-2015-095898. Epub 2016 Aug 18.

  PMID: 27539507 RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Aníbal Báez Suárez, PhD

  University of Las Palmas de Gran Canaria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aníbal Báez Suárez, PhD

CONTACT

652077692; anibal.baez@ulpgc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The intervention to which the subjects have been assigned, the specialist and the researcher who collects the information and performs the follow-ups will be blinded, using the simulated NESA XSIGNAL® device. Data analysis will also be performed in a blinded fashion. Patients will be assigned to NESA XSIGNAL® device 1 or 2. These devices will be labeled "1" and "2" and only the manufacturer will know which is the real or the simulated one. In the same way, to avoid subjective comparisons of the participants, in the same room, device 1 and 2 at the same time will not be used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 26, 2022
• Study Start: May 25, 2021
• Primary Completion: September 25, 2025
• Study Completion: December 25, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)