Effectiveness and Safety of Implantable Neurostimulation Systems for Chronic Pain: A Spanish Multicenter Study (STIM-RENASED)

Sociedad Espanola del Dolor

Status: Enrolling

Conditions: Chronic Pain

Study type: Observational

Funder types: Other

Identifiers

NCT05770700

PI 238/22

Details and patient eligibility

About

Chronic pain is a prevalent condition that negatively affects patients' quality of life. Implantable neurostimulation therapies have been proposed as a treatment option for chronic 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 implantable stimulation systems for chronic pain treatment in Spain.

Full description

All Spanish hospitals that implant neurostimulation systems for pain treatment 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 six 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.