Efficacy of the NXSignal Device for the Treatment of Anterior Cruciate Ligament Injuries
NCT ID: NCT05207943
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2021-05-25
2025-12-25
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
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.
Study Groups
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Non-invasive Neuromodulation
Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level and and in the popliteal fossa.
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
Placebo microcurrents Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level and in the popliteal fossa.
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
Control
Participant will maintain the conventional rehabilitation treatment
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* Not having signed the informed consent.
* Urgent surgical interventions.
16 Years
ALL
No
Sponsors
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University of Las Palmas de Gran Canaria
OTHER
Responsible Party
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Aníbal Báez Suárez
Principal Investigator
Principal Investigators
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Aníbal Báez Suárez, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Las Palmas de Gran Canaria
Locations
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University of Las Palmas de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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NESALCA
Identifier Type: -
Identifier Source: org_study_id
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