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

Chronic Pain Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05770700
• Other study ID #: PI 238/22
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: May 2024
• Source: Sociedad Espanola del Dolor
• Contact: Antonio Ojeda, MD
• Phone: 0034911729144
• Email: renased[@]sedolor.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 504
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital Universitario Puerta del Mar	Cádiz
Spain	Complejo Hospitalario Universitario de Cartagena	Cartagena	Murcia
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Madrid
Spain	Hospital FREMAP Majadahonda	Majadahonda	Madrid
Spain	Hospital Regional Univeristario de Málaga	Málaga
Spain	Complexo Hospitalario Univeritario de Ourense	Ourense
Spain	Hospital Universitari Son Espases	Palma De Mallorca
Spain	Hospital Universitario de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Universitari i Politècnic La Fe	Valencia
Spain	Complejo Hospitalario Universitario de Vigo	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Espanola del Dolor

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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