NCT05970081

Effectiveness and Safety of Implantable Intrathecal Systems for Refractory Pain in Spain (INTRATHECAL-RENASED)

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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 504 (estimated)
• Sponsor: Sociedad Espanola del Dolor · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Refractory pain is a prevalent condition that negatively affects patients' quality of life. Intrathecal implantable systems have been proposed as a treatment option for refractory pain. However, real-world data on the effectiveness and safety of these therapies in Spain are scarce. This study aims to obtain real-world data on the effectiveness and safety of intrathecal implantable systems for refractory pain treatment in Spain.

Detailed description

All Spanish hospitals that implant intrathecal systems for refractory pain will be invited to participate in the study. Patients will be recruited before the procedure, and before providing data to the registry, the study will be explained to them, and they will sign an informed consent form. Demographic data related to the pathology and procedure will be collected. Follow-up will be conducted at three and twelve months after the procedure.

Conditions

• Refractory Pain

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2023-08-01
• Last updated: 2024-05-22

Locations

9 sites across 1 country: Spain