Using the NXSignal Device to treat ACL injuries
Efficacy of the NXSignal Device for the Treatment of Anterior Cruciate Ligament Injuries. Randomized Controlled Clinical Trial
This study is testing if the NXSignal device can help people recover better from ACL injuries after surgery compared to a placebo or standard rehab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of Las Palmas de Gran Canaria Academic / other |
| Locations | 1 site (Las Palmas de Gran Canaria, Las Palmas) |
| Trial ID | NCT05207943 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of the NXSignal device in treating anterior cruciate ligament (ACL) injuries. It involves a randomized, triple-blind design where patients who have undergone ACL surgery will be divided into groups receiving either the NXSignal treatment, a placebo treatment, or standard rehabilitation. The study aims to compare outcomes among these groups to determine the effectiveness of the NXSignal device in improving recovery and preventing further joint issues. The trial will ensure that neither the patients nor the recovery specialists know which treatment is being administered to maintain objectivity.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals over 16 years old who have undergone ACL surgery and are mentally competent to participate.
Not a fit: Patients with previous knee surgeries or those with contraindications for the NXSignal device will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive alternative to surgery for ACL injuries, potentially reducing recovery time and healthcare costs.
How similar studies have performed: While the use of electrotherapy techniques in rehabilitation is common, the specific application of the NXSignal device for ACL injuries is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Las Palmas de Gran Canaria, Las Palmas
- University of Las Palmas de Gran Canaria — Las Palmas de Gran Canaria, Las Palmas, Spain (Recruiting)
Study contacts
- Principal investigator: Aníbal Báez Suárez, PhD — University of Las Palmas de Gran Canaria
- Study coordinator: Aníbal Báez Suárez, PhD
- Email: anibal.baez@ulpgc.es
- Phone: 652077692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.