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

NCT ID: NCT05770700

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

RECRUITING

Total Enrollment

504 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic 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 FREMAP Majadahonda

Majadahonda, Madrid, Spain

Site Status RECRUITING

Complejo Hospitalario Universitario de Cartagena

Cartagena, Murcia, Spain

Site Status RECRUITING

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Site Status RECRUITING

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, , Spain

Site Status NOT_YET_RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario de La Princesa

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, , Spain

Site Status RECRUITING

Hospital Regional Univeristario de Málaga

Málaga, , Spain

Site Status RECRUITING

Complexo Hospitalario Univeritario de Ourense

Ourense, , Spain

Site Status RECRUITING

Hospital Universitari Son Espases

Palma de Mallorca, , Spain

Site Status RECRUITING

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, , Spain

Site Status NOT_YET_RECRUITING

Complejo Hospitalario Universitario de Vigo

Vigo, , Spain

Site Status NOT_YET_RECRUITING

Countries

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Spain

Central Contacts

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Antonio Ojeda, MD

Role: CONTACT

[email protected]
0034911729144

Facility Contacts

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Rogelio Rosado, MD

Role: primary

María Luz Padilla del Rey, MD

Role: primary

Laura Gómez Glia, MD

Role: primary

Antonio Ojeda, MD

Role: primary

[email protected]

Miren Revuelta, MD, PhD

Role: primary

Anna Server, MD

Role: primary

Jose Manuel Trinidad Martín-Arroyo, MD

Role: primary

Angel Alonso, MD

Role: primary

Concepción Pérez, MD, PhD

Role: primary

Agustin Mendiola, MD, PhD

Role: primary

Mariano Fernández Baena, MD

Role: primary

Luz Cánovas Martínez, MD

Role: primary

Hermann Ribera Leclerc, MD

Role: primary

Isaac Peña, MD

Role: primary

Maria Ángeles Canós Verdecho, MD

Role: primary

Alfonso Carrregal, MD

Role: primary

Other Identifiers

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PI 238/22

Identifier Type: -

Identifier Source: org_study_id

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