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

Sociedad Espanola del Dolor504 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

504

Conditions

Chronic Pain

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

Hospital FREMAP Majadahonda

Majadahonda, Madrid, Spain

RECRUITING

Complejo Hospitalario Universitario de Cartagena

Outcomes

Primary Outcomes

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

Percentage of patients who experience a reduction of at least 50% in the intensity of their predominant pain compared to the initial value, assessed twelve months after the implantation of the neurostimulation 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)

Time frame: Twelve months

Secondary Outcomes

Percentage of patients with at least 50 % pain relief in the area of their predominant pain at six months.

Percentage of patients who experience a reduction of at least 50% in the intensity of their predominant pain compared to the initial value, assessed six months after the implantation of the neurostimulation 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)

Time frame: Six months

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

Percentage of patients who experience a reduction of at least 50% in the intensity of their non-predominant pain compared to the initial value, assessed six and twelve months after the implantation of the neurostimulation 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)

Time frame: Six and twelve months

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

The impact of the treatment on the patient's health-related quality of life will be evaluated using the EQ-5D-5L questionnaire at six and twelve months after implantation. The EQ-5D-5L assesses quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is scored on a scale of 1 (no problems) to 5 (extreme problems), generating a 5-digit code that corresponds to the patient's health status.

Central Contacts

Antonio Ojeda, MD

CONTACT

0034911729144 renased@sedolor.es

Data from ClinicalTrials.gov

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