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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain

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.

• Study Type: Observational
• Enrollment (Estimated): 504

Contacts and Locations

• Study Contact: Name: Antonio Ojeda, MD; Phone Number: 0034911729144; Email: renased@sedolor.es

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona
    • Contact: Antonio Ojeda, MD; Email: ojeda@clinic.cat
    • Principal Investigator: Antonio Ojeda, MD
  • Barcelona, Spain
    • Not yet recruiting
    • Hospital Universitario Vall d'Hebron
    • Contact: Anna Server, MD
  • Barcelona, Spain
    • Not yet recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Miren Revuelta, MD, PhD
    • Principal Investigator: Miren Revuelta
  • Cádiz, Spain, 11009
    • Not yet recruiting
    • Hospital Universitario Puerta del Mar
    • Contact: Jose Manuel Trinidad Martín-Arroyo, MD
    • Principal Investigator: Jose Manuel Trinidad Martín-Arroyo, MD
  • Madrid, Spain, 28007
    • Not yet recruiting
    • Hospital General Universitario Gregorio Marañón
    • Contact: Angel Alonso, MD
    • Principal Investigator: Angel Alonso, MD
  • Madrid, Spain, 28222
    • Recruiting
    • Hospital Universitario Puerta de Hierro Majadahonda
    • Contact: Agustín Mendiola, MD, PhD
    • Principal Investigator: Agustin Mendiola, MD, PhD
  • Madrid, Spain, 28028
    • Not yet recruiting
    • Hospital Universitario de La Princesa
    • Contact: Concepción Pérez, MD, PhD
    • Principal Investigator: Concepción Pérez, Md, PhD
  • Málaga, Spain, 29010
    • Not yet recruiting
    • Hospital Regional Univeristario de Málaga
    • Contact: Mariano Fernández Baena, MD
    • Principal Investigator: Mariano Fernández Baena, MD
  • Ourense, Spain, 32005
    • Recruiting
    • Complexo Hospitalario Univeritario de Ourense
    • Contact: Luz Cánovas Martínez, MD
    • Principal Investigator: Luz Cánovas Martínez, MD
  • Palma De Mallorca, Spain, 07120
    • Not yet recruiting
    • Hospital Universitari Son Espases
    • Contact: Hermann Ribera Leclerc, MD
    • Principal Investigator: Hermann Ribera Leclerc, MD
  • Valencia, Spain, 46026
    • Not yet recruiting
    • Hospital Universitari i Politecnic La Fe
    • Contact: Maria Ángeles Canós Verdecho, MD
    • Principal Investigator: Maria Ángeles Canós Verdecho, MD
  • Vigo, Spain, 36204
    • Not yet recruiting
    • Complejo Hospitalario Universitario de Vigo
    • Contact: Alfonso Carrregal, MD
  • Madrid
    • Majadahonda, Madrid, Spain, 28221
      • Recruiting
      • Hospital FREMAP Majadahonda
      • Contact: Rogelio Rosado, MD
  • Murcia
    • Cartagena, Murcia, Spain, 30203
      • Not yet recruiting
      • Complejo Hospitalario Universitario de Cartagena
      • Contact: Maria Luz Padilla del Rey, MD
      • Principal Investigator: Maria Luz Padilla del Rey, MD
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Not yet recruiting
      • Hospital Universitario de Navarra
      • Contact: Laura Gómez Glia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic refractory pain who are candidates for treatment with a implantable neurostimulation system.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Twelve months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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.	Six and twelve months
Patient Global Impression of Improvement	Assessment of clinical global impression of improvement using the PGI-I scale at six and twelve months after implantation of the neurostimulation system. The PGI-I score ranges from 1 (Very much better) through to 7 (Very much worse). The lower the score, the better the improvement.	Six and twelve months
Patient Satisfaction	Percentage of implanted subjects satisfied with the treatment at six and twelve months after the implantation of the neurostimulation system. defined as indicating: "since the start of the therapy has the pain improved? yes/no", "Are you satisfied with the treatment?" yes/no or "would you agree to the treatment again?" yes/no	Six and twelve months
Number of Adverse Events as a Measure of Safety	Number and percentage of patients with adverse effects related to therapy at six and twelve months after implantation of the neurostimulation system.	Six and twelve months

Collaborators and Investigators

• Sponsor: Sociedad Espanola del Dolor

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 5, 2023
• First Submitted That Met QC Criteria: March 5, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Spinal cord stimulation; Peripheral nerve stimulation; Dorsal root ganglion stimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: PI 238/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No