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

September 23, 2023 updated by: Sociedad Espanola del Dolor

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)

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

504

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clínic de Barcelona
        • Contact:
          • Antonio Ojeda, MD
      • Madrid, Spain, 28028
        • Not yet recruiting
        • Hospital Universitario de la Princesa
        • Contact:
          • Concepción Pérez, MD, PhD
        • Principal Investigator:
          • Concepción Pérez, Md, PhD
      • Madrid, Spain, 28222
        • Not yet recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
        • Contact:
          • Agustín Mendiola, MD, PhD
        • Principal Investigator:
          • Agustin Mendiola, MD, PhD
      • Murcia, Spain, 30203
        • Recruiting
        • Complejo Hospitalario Universitario de Cartagena
        • Contact:
          • Maria Luz Padilla del Rey, MD
        • Principal Investigator:
          • Maria Luz Padilla del Rey, MD
      • Ourense, Spain, 32005
        • Not yet recruiting
        • Complexo Hospitalario Univeritario de Ourense
        • Contact:
          • Luz Cánovas Martínez, MD
        • Principal Investigator:
          • Luz Cánovas Martínez, MD
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari I Politecnic La Fe
        • Contact:
          • Maria Ángeles Canós Verdecho, MD
        • Principal Investigator:
          • Maria Ángeles Canós Verdecho, MD
    • Andalucia
      • Málaga, Andalucia, Spain, 29010
        • Not yet recruiting
        • Hospital Regional Univeristario de Málaga
        • Contact:
          • Mariano Fernández Baena, MD
        • Principal Investigator:
          • Mariano Fernández Baena, MD
    • Balearic Island
      • Palma De Mallorca, Balearic Island, Spain, 07120
        • Not yet recruiting
        • Hospital Universitari Son Espases
        • Contact:
          • Hermann Ribera Leclerc, MD
        • Principal Investigator:
          • Hermann Ribera Leclerc
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Not yet recruiting
        • Hospital Universitario de Navarra
        • Contact:
          • Laura Gómez Glia, MD
        • Principal Investigator:
          • Laura Gómez Glia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with refractory pain who are candidates for treatment with an implantable intrathecal infusion 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at one year
Time Frame: 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)
Twelve months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compared change from baseline on health-related quality of life scores (EQ Index)
Time Frame: 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.
Three and twelve months
Patient Global Impression of Improvement (PGI-I)
Time Frame: 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.
Three and twelve months
Patient Satisfaction
Time Frame: 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
Three and twelve months
Number of Adverse Events as a Measure of Safety
Time Frame: 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.
Three and twelve months
Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at three months
Time Frame: 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
Percentage of patients with at least 50 percent pain relief in the area of their non-predominant pain at one year
Time Frame: 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)
Twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sociedad Espanola del Dolor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 23, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5215

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Refractory Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe