Noninvasive neuromodulation for patients with knee prostheses
Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation. PRONES Trial
This study is testing whether a new device can help people with knee replacements feel less pain and improve their daily activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Las Palmas de Gran Canaria Academic / other |
| Locations | 1 site (Santa Cruz De Tenerife) |
| Trial ID | NCT06134999 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the NESA XSignal device in improving pain, functionality, and quality of life in patients who have undergone total knee replacement surgery. Participants will be randomly assigned to either a control group receiving standard treatment or an experimental group receiving treatment with the NESA XSignal device, while both groups continue their usual care. The study aims to provide insights into the potential benefits of non-invasive neuromodulation as a therapeutic modality for knee prosthesis patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have recently undergone total knee replacement surgery.
Not a fit: Patients with total knee prostheses older than 3 months or those with complications related to their prosthesis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance pain management and recovery outcomes for patients with knee prostheses.
How similar studies have performed: While the use of neuromodulation techniques is gaining interest, this specific application in knee prosthesis patients is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years of age * Total knee replacement surgery at the Hospital San Juan de Dios de Tenerife. * Be able to freely consent to take part in the study. Exclusion Criteria: * No contraindications for treatment with NXSignal: pacemakers, internal bleeding, poor skin condition with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or electricity phobia. * Patients with total knee prosthesis of more than 3 months of evolution. * Patients with total knee prosthesis with complications.
Where this trial is running
Santa Cruz De Tenerife
- José Carlos del Castillo Rodríguez — Santa Cruz De Tenerife, Spain (Recruiting)
Study contacts
- Principal investigator: José Carlos del Castillo Rodríguez, PhD — Hospital San Juan de Dios Tenerife
- Study coordinator: José Carlos del Castillo Rodríguez, PhD
- Email: josecarlos.delcastillo@sjd.es
- Phone: +34 922 23 55 12
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.