Effectiveness and Safety of Implantable Intrathecal Systems for Refractory Pain in Spain (INTRATHECAL-RENASED)

Refractory Pain Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05970081
• Other study ID #: 5215
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: September 2023
• 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

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 504
• Est. completion date: August 1, 2025
• Est. primary completion date: August 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

• Pain, Intractable
• Refractory Pain

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Madrid
Spain	Hospital Regional Univeristario de Málaga	Málaga	Andalucia
Spain	Complejo Hospitalario Universitario de Cartagena	Murcia
Spain	Complexo Hospitalario Univeritario de Ourense	Ourense
Spain	Hospital Universitari Son Espases	Palma De Mallorca	Balearic Island
Spain	Hospital Universitario de Navarra	Pamplona	Navarra
Spain	Hospital Universitari i Politècnic La Fe	Valencia

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 percent pain relief in the area of their predominant pain at one year	Percentage of patients who experience a reduction of at least 50 percent in the intensity of their predominant pain compared to the initial value, assessed twelve months after the implantation of the intrathecal drug delivery 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 percent pain relief in the area of their predominant pain at three months	Percentage of patients who experience a reduction of at least 50 percent in the intensity of their predominant pain compared to the initial value, assessed three months after the implantation of the implantable intrathecal 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)	Three months
Secondary	Percentage of patients with at least 50 percent pain relief in the area of their non-predominant pain at one year	Percentage of patients who experience a reduction of at least 50 percent in the intensity of their non-predominant pain compared to the initial value, assessed twelve months after the implantation of the intrathecal drug delivery 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	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 three 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.	Three and twelve months
Secondary	Patient Global Impression of Improvement (PGI-I)	Assessment of clinical global impression of improvement using the PGI-I scale at three and twelve months after implantation of the intrathecal drug delivery 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.	Three and twelve months
Secondary	Patient Satisfaction	Percentage of implanted subjects satisfied with the treatment at three and twelve months after the implantation of the intrathecal drug delivery 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	Three 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 three and twelve months after implantation of the intrathecal drug delivery system.	Three and twelve months