Clinical trial NCT05207943: Efficacy of the NXSignal Device for the Treatment of Anterior Cruciate Ligament Injuries
Official title: Efficacy of the NXSignal Device for the Treatment of Anterior Cruciate Ligament Injuries. Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Keywords: physical therapy modality
Electric Stimulation Therapy
Anterior Cruciate Ligament
Lead sponsor: University of Las Palmas de Gran Canaria
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knee circumference
timeFrame: Up to 4 month
measure: Motor Control
timeFrame: Up to 4 month
measure: Functional ability
timeFrame: Up to 4 month
measure: Level of Pain
timeFrame: Up to 4 month
Secondary outcomes:
measure: Range of motion
timeFrame: Up to 4 month
measure: Brain activity
timeFrame: Up to 4 month
measure: Quality of life related to health
timeFrame: Up to 4 month
measure: Psychological perception test:
timeFrame: Up to 4 month
Other outcomes:
Locations:
city: Las Palmas de Gran Canaria
country: Spain
facility: University of Las Palmas de Gran Canaria
state: Las Palmas
Study officials:
affiliation: University of Las Palmas de Gran Canaria
name: Aníbal Báez Suárez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 10.1177/0363546516629944. Epub 2016 Feb 26.
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.
citation: 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.
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 multidisciplinary consensus. Br J Sports Med. 2016 Dec;50(24):1506-1515. doi: 10.1136/bjsports-2015-095898. Epub 2016 Aug 18.