Evaluating neurostimulation systems for chronic pain in Spain
Effectiveness and Safety of Implantable Neurostimulation Systems for the Treatment of Chronic Refractory Pain in Spain: Prospective Multicenter Study From the Spanish Pain Society Registry (STIM-RENASED)
This study is testing how well implantable neurostimulation systems work and if they are safe for people with chronic pain in Spain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 504 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sociedad Espanola del Dolor Academic / other |
| Locations | 16 sites (Majadahonda, Madrid and 15 other locations) |
| Trial ID | NCT05770700 on ClinicalTrials.gov |
What this trial studies
This study aims to gather real-world data on the effectiveness and safety of implantable neurostimulation systems for treating chronic pain in Spain. It will involve multiple hospitals across the country, where patients will be recruited prior to their procedures. Participants will provide demographic information and will be followed up at six and twelve months post-implantation to assess outcomes. The study seeks to fill the gap in knowledge regarding these therapies in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates include patients suffering from chronic refractory pain who are considering implantable neurostimulation systems.
Not a fit: Patients who may not benefit include those unable to complete follow-up or who do not understand the Spanish language.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of neurostimulation therapies for chronic pain, potentially improving treatment options for patients.
How similar studies have performed: While there is limited real-world data specific to Spain, similar studies in other regions have shown promising results for neurostimulation therapies in chronic pain management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chronic refractory pain patients candidates for treatment with an implantable neurostimulation system. * Accept to participate in the study and sign informed consent. Exclusion Criteria: * Patients in whom it would be difficult to complete follow-up. * Insufficient understanding of the Spanish language. * Pregnancy.
Where this trial is running
Majadahonda, Madrid and 15 other locations
- Hospital FREMAP Majadahonda — Majadahonda, Madrid, Spain (Recruiting)
- Complejo Hospitalario Universitario de Cartagena — Cartagena, Murcia, Spain (Recruiting)
- Hospital Universitario de Navarra — Pamplona, Navarre, Spain (Recruiting)
- Hospital Clinic de Barcelona — Barcelona, Spain (Recruiting)
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Not_yet_recruiting)
- Hospital Universitario Vall d'Hebron — Barcelona, Spain (Not_yet_recruiting)
- Hospital Universitario Puerta del Mar — Cadiz, Spain (Not_yet_recruiting)
- Hospital General Universitario Gregorio Marañón — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario de La Princesa — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario Puerta de Hierro Majadahonda — Madrid, Spain (Recruiting)
- Hospital Regional Univeristario de Málaga — Málaga, Spain (Recruiting)
- Complexo Hospitalario Univeritario de Ourense — Ourense, Spain (Recruiting)
- Hospital Universitari Son Espases — Palma de Mallorca, Spain (Recruiting)
- Hospital Universitario Virgen del Rocío — Seville, Spain (Recruiting)
- Hospital Universitari i Politècnic La Fe — Valencia, Spain (Not_yet_recruiting)
- Complejo Hospitalario Universitario de Vigo — Vigo, Spain (Not_yet_recruiting)
Study contacts
- Study coordinator: Antonio Ojeda, MD
- Email: renased@sedolor.es
- Phone: 0034911729144
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.