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

Sociedad Espanola del Dolor

Status: Enrolling

Conditions: Refractory Pain

Study type: Observational

Funder types: Other

Identifiers

NCT05970081

5215

Details and patient eligibility

About

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.

Full 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.

Enrollment: 504 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.