Clinical trial NCT05970081: Effectiveness and Safety of Implantable Intrathecal Systems for Refractory Pain in Spain (INTRATHECAL-RENASED)
Official title: Effectiveness and Safety of Implantable Intrathecal Systems for the Treatment of Chronic Refractory Pain in Spain: Prospective Multicenter Study From the Spanish Pain Society Registry (INTRATHECAL-RENASED)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Refractory Pain
Keywords: Intrathecal Drug Delivery
Implantable Infusion Pump
Refractory Pain
Lead sponsor: Sociedad Espanola del Dolor
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with refractory pain who are candidates for treatment with an implantable intrathecal infusion system.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at one year
timeFrame: Twelve months
Secondary outcomes:
measure: Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at three months
timeFrame: Three months
measure: Percentage of patients with at least 50 percent pain relief in the area of their non-predominant pain at one year
timeFrame: Twelve months
measure: Compared change from baseline on health-related quality of life scores (EQ Index)
timeFrame: Three and twelve months
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: Three and twelve months
measure: Patient Satisfaction
timeFrame: Three and twelve months
measure: Number of Adverse Events as a Measure of Safety
timeFrame: Three and twelve months
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Regional Univeristario de Málaga
state: Andalucia
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Espases
state: Balearic Island
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Murcia
country: Spain
facility: Complejo Hospitalario Universitario de Cartagena
city: Ourense
country: Spain
facility: Complexo Hospitalario Univeritario de Ourense
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
Study officials:
References: