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

Recruiting

• Conditions: Refractory Pain

• Registration Number: NCT05970081
• Lead Sponsor: Sociedad Espanola del Dolor

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-07-24
• Study Start: 2023-08-01
• Study First Posted: 2023-08-01
• Status Verified: 2023-09
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 504

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at one year	Twelve 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 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)

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at three months	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)
Compared change from baseline on health-related quality of life scores (EQ Index)	Three and twelve months	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.
Patient Satisfaction	Three and twelve months	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
Percentage of patients with at least 50 percent pain relief in the area of their non-predominant pain at one year	Twelve months	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)
Patient Global Impression of Improvement (PGI-I)	Three and twelve months	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.
Number of Adverse Events as a Measure of Safety	Three and twelve months	Number and percentage of patients with adverse effects related to therapy at three and twelve months after implantation of the intrathecal drug delivery system.

Trial Locations

Locations (9)

Hospital Universitario Puerta de Hierro Majadahonda; 🇪🇸 Madrid, Spain

Hospital Regional Univeristario de Málaga; 🇪🇸 Málaga, Andalucia, Spain

Hospital Universitario de La Princesa; 🇪🇸 Madrid, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitari Son Espases; 🇪🇸 Palma De Mallorca, Balearic Island, Spain

Hospital Universitario de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Complejo Hospitalario Universitario de Cartagena; 🇪🇸 Murcia, Spain

Complexo Hospitalario Univeritario de Ourense; 🇪🇸 Ourense, Spain

Hospital Universitari i Politècnic La Fe; 🇪🇸 Valencia, Spain