Anterior Cruciate Ligament InjuriesNCT05207943
Efficacy of the NXSignal Device for the Treatment of Anterior Cruciate Ligament Injuries
A study testing Non-invasive Neuromodulation in people with Anterior Cruciate Ligament Injuries, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Non-invasive Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 25 May 2021to 25 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Las Palmas de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35016
Anibal Báez, Professor, +34652077692, anibal.baez@ulpgc.es
Aníbal Báez Suárez, Professor
About this study
Official title: Efficacy of the NXSignal Device for the Treatment of Anterior Cruciate Ligament Injuries. Randomized Controlled Clinical Trial
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 .
Read more
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Non-invasive Neuromodulation, Placebo Non-invasive Neuromodulation
- Keywords
- physical therapy modality, Electric Stimulation Therapy, Anterior Cruciate Ligament
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive NeuromodulationDevice
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 NeuromodulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebo Non-invasive Neuromodulation |
| Control | No intervention | Participant will maintain the conventional rehabilitation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee circumference
Centimeter measurement supra and infrapatellar with a tape measure with the leg in extension and without muscle contraction.
Measured: Up to 4 month
Motor Control
It will be assessed through a dop jump, vertical jump test and Single leg squat.
Measured: Up to 4 month
Functional ability
We will use the International Knee Documentation Committee (IKDC) questionnaire.
Measured: 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)
Measured: Up to 4 month
Secondary outcomes (4)
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.
Measured: Up to 4 month
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
Measured: Up to 4 month
Quality of life related to health
The SF-12 scale will be applied
Measured: Up to 4 month
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
Measured: Up to 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start25 May 2021
- Primary completion25 Sep 2025 (estimated)
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Las Palmas de Gran Canaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aníbal Báez Suárez, University of Las Palmas de Gran Canaria
- Investigators
- Aníbal Báez Suárez, PhD, Principal investigator, University of Las Palmas de Gran Canaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207943
- Sponsor's protocol ID
- NESALCA
- Status last verified
- Aug 2025
- First submitted
- 28 Dec 2021
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26920430Stewart 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.
PubMed 27590175Kakavas 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.
PubMed 33264774van 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.
PubMed 27539507
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the NXSignal Device for the Treatment of Anterior Cruciate Ligament Injuries. Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05207943
- Acronym / sponsor ID
- NESALCA
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- physical therapy modality, Electric Stimulation Therapy, Anterior Cruciate Ligament
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Las Palmas de Gran CanariaUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 25 Sep 2025 (estimated)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-invasive Neuromodulation | Experimental | Device: Non-invasive NeuromodulationIntervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level and and in the popliteal fossa. |
| Placebo Non-invasive Neuromodulation | Sham comparator | Device: Placebo Non-invasive NeuromodulationPlacebo microcurrents Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level and in the popliteal fossa. |
| Control | No intervention | –Participant will maintain the conventional rehabilitation treatment |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive NeuromodulationThe 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. | Device | Non-invasive Neuromodulation |
| Placebo Non-invasive NeuromodulationThe 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 | Device | Placebo Non-invasive Neuromodulation |
Primary outcome
Knee circumference
Time frame: Up to 4 month
Centimeter measurement supra and infrapatellar with a tape measure with the leg in extension and without muscle contraction.
Motor Control
Time frame: Up to 4 month
It will be assessed through a dop jump, vertical jump test and Single leg squat.
Functional ability
Time frame: Up to 4 month
We will use the International Knee Documentation Committee (IKDC) questionnaire.
Level of Pain
Time frame: Up to 4 month
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)
4 secondary outcomes
Range of motion
Time frame: Up to 4 month
Brain activity
Time frame: Up to 4 month
Quality of life related to health
Time frame: Up to 4 month
Psychological perception test:
Time frame: Up to 4 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Results publication: PubMed 26920430Sanders 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.
- Results publication: PubMed 27590175Stewart 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.
- Results publication: PubMed 33264774Kakavas 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.
- Results publication: PubMed 27539507van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aníbal Báez Suárez, PhD principal investigator
University of Las Palmas de Gran Canaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive Neuromodulation in people with Anterior Cruciate Ligament Injuries, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aníbal Báez Suárez, PhD (652077692, anibal.baez@ulpgc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee circumference (time frame: Up to 4 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05207943, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.