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

NCT05970081 | Unknown

• 1 other identifier: 5215
• Study Type: observational
• Target: 504
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Refractory Pain

Keywords

Intrathecal Drug Delivery; Implantable Infusion Pump; Refractory Pain

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at one year

  Percentage of patients who experience a reduction of at least 50 percent in the intensity of their predominant pain compared to the initial value, assessed twelve months after the implantation of the intrathecal drug delivery system. Pain intensity will be measured using an 11-point Numeric Pain Rating Scale (NPRS), with a range from 0 (no pain) to 10 (maximum pain possible)

  Twelve months

Secondary Outcomes (6)

• Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at three months

  Three months

• Percentage of patients with at least 50 percent pain relief in the area of their non-predominant pain at one year

  Twelve months

• Compared change from baseline on health-related quality of life scores (EQ Index)

  Three and twelve months

• Patient Global Impression of Improvement (PGI-I)

  Three and twelve months

• Patient Satisfaction

  Three and twelve months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with refractory pain who are candidates for treatment with an implantable intrathecal infusion system.

You may qualify if:

• Chronic refractory pain patients candidates for treatment with an implantable neurostimulation system.
• Accept to participate in the study and sign informed consent.

You may not qualify if:

• Patients in whom it would be difficult to complete follow-up.
• Insufficient understanding of the Spanish language.
• Pregnancy.

Sponsors & Collaborators

• Sociedad Espanola del Dolor: lead

Study Sites (9)

Hospital Regional Univeristario de Málaga

Málaga, Andalusia, 29010, Spain

RECRUITING

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Island, 07120, Spain

NOT YET RECRUITING

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

NOT YET RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital Universitario de La Princesa

Madrid, 28028, Spain

NOT YET RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, 28222, Spain

NOT YET RECRUITING

Complejo Hospitalario Universitario de Cartagena

Murcia, 30203, Spain

RECRUITING

Complexo Hospitalario Univeritario de Ourense

Ourense, 32005, Spain

NOT YET RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

RECRUITING

MeSH Terms

Conditions

Pain, Intractable

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Antonio Ojeda, MD

CONTACT

0034911729144; renased@sedolor.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 22, 2024

Record last verified: 2023-09

Locations

ES (9)