Effectiveness and safety of implantable systems for treating refractory pain in Spain
Effectiveness and Safety of Implantable Intrathecal Systems for the Treatment of Chronic Refractory Pain in Spain: Prospective Multicenter Study From the Spanish Pain Society Registry (INTRATHECAL-RENASED)
This study is testing how well and safely implantable systems can help people in Spain who have severe pain that doesn't go away with other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 504 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sociedad Espanola del Dolor Academic / other |
| Locations | 9 sites (Málaga, Andalucia and 8 other locations) |
| Trial ID | NCT05970081 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world data on the effectiveness and safety of intrathecal implantable systems for patients suffering from refractory pain in Spain. Participating hospitals will recruit patients prior to the implantation procedure, collecting demographic and clinical data. Follow-up assessments will occur at three and twelve months post-procedure to evaluate outcomes. The study seeks to fill the gap in existing literature regarding the use of these systems in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with chronic refractory pain who are candidates for treatment with an implantable neurostimulation system.
Not a fit: Patients who may not benefit from this study include those who cannot complete follow-up or do not understand the Spanish language.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of intrathecal systems, potentially improving treatment options for patients with refractory pain.
How similar studies have performed: While there is limited real-world data on this specific approach in Spain, similar studies in other regions have shown promising results with intrathecal drug delivery systems.
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
Málaga, Andalucia and 8 other locations
- Hospital Regional Univeristario de Málaga — Málaga, Andalucia, Spain (Recruiting)
- Hospital Universitari Son Espases — Palma De Mallorca, Balearic Island, Spain (Not_yet_recruiting)
- Hospital Universitario de Navarra — Pamplona, Navarra, Spain (Not_yet_recruiting)
- Hospital Clinic de Barcelona — Barcelona, Spain (Recruiting)
- Hospital Universitario de La Princesa — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario Puerta de Hierro Majadahonda — Madrid, Spain (Not_yet_recruiting)
- Complejo Hospitalario Universitario de Cartagena — Murcia, Spain (Recruiting)
- Complexo Hospitalario Univeritario de Ourense — Ourense, Spain (Not_yet_recruiting)
- Hospital Universitari i Politècnic La Fe — Valencia, Spain (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.