Clinical trial NCT05770700: Effectiveness and Safety of Implantable Neurostimulation Systems for Chronic Pain: A Spanish Multicenter Study (STIM-RENASED)
Official title: Effectiveness and Safety of Implantable Neurostimulation Systems for the Treatment of Chronic Refractory Pain in Spain: Prospective Multicenter Study From the Spanish Pain Society Registry (STIM-RENASED)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Keywords: Spinal cord stimulation
Dorsal root ganglion stimulation
Peripheral nerve stimulation
Lead sponsor: Sociedad Espanola del Dolor
Sponsor class: OTHER
First posted: 2023-03-15
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 chronic refractory pain who are candidates for treatment with a implantable neurostimulation system.

Brief summary: 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.

Detailed 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.

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 % 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 % pain relief in the area of their predominant pain at six months.
timeFrame: Six months
measure: Percentage of patients with at least 50 % pain relief in the area of their non-predominant pain at one year.
timeFrame: Six and twelve months
measure: Compared change from baseline on health-related quality of life scores (EQ Index)
timeFrame: Six and twelve months
measure: Patient Global Impression of Improvement
timeFrame: Six and twelve months
measure: Patient Satisfaction
timeFrame: Six and twelve months
measure: Number of Adverse Events as a Measure of Safety
timeFrame: Six and twelve months
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Hospital FREMAP Majadahonda
state: Madrid
city: Cartagena
country: Spain
facility: Complejo Hospitalario Universitario de Cartagena
state: Murcia
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Cádiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Málaga
country: Spain
facility: Hospital Regional Univeristario de Málaga
city: Ourense
country: Spain
facility: Complexo Hospitalario Univeritario de Ourense
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Espases
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
Study officials:
References: