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

NCT ID: NCT05970081

Last Updated: 2024-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

504 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-08-01

Brief Summary

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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

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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

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Refractory Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sociedad Espanola del Dolor

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Regional Univeristario de Málaga

Málaga, Andalusia, Spain

Site Status RECRUITING

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Island, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Site Status NOT_YET_RECRUITING

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario de La Princesa

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Complejo Hospitalario Universitario de Cartagena

Murcia, , Spain

Site Status RECRUITING

Complexo Hospitalario Univeritario de Ourense

Ourense, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Antonio Ojeda, MD

Role: CONTACT

0034911729144

Facility Contacts

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Mariano Fernández Baena, MD

Role: primary

Hermann Ribera Leclerc, MD

Role: primary

Laura Gómez Glia, MD

Role: primary

Antonio Ojeda, MD

Role: primary

Concepción Pérez, MD, PhD

Role: primary

Agustín Mendiola, MD, PhD

Role: primary

Maria Luz Padilla del Rey, MD

Role: primary

Luz Cánovas Martínez, MD

Role: primary

Maria Ángeles Canós Verdecho, MD

Role: primary

Other Identifiers

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5215

Identifier Type: -

Identifier Source: org_study_id

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