NCT05770700

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
504

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

March 5, 2023

Last Update Submit

May 21, 2024

Conditions

Chronic Pain

Keywords

Spinal cord stimulationDorsal root ganglion stimulationPeripheral nerve stimulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Percentage of patients with at least 50 % pain relief in the area of their predominant pain at six months.

    Six months

  • Percentage of patients with at least 50 % pain relief in the area of their non-predominant pain at one year.

    Six and twelve months

  • Compared change from baseline on health-related quality of life scores (EQ Index)

    Six and twelve months

  • Patient Global Impression of Improvement

    Six and twelve months

  • Patient Satisfaction

    Six and twelve months

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Chronic refractory pain patients candidates for treatment with an implantable neurostimulation system.
  • Accept to participate in the study and sign informed consent.

You may not qualify if:

  • Patients in whom it would be difficult to complete follow-up.
  • Insufficient understanding of the Spanish language.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Hospital FREMAP Majadahonda

Majadahonda, Madrid, 28221, Spain

RECRUITING

Complejo Hospitalario Universitario de Cartagena

Cartagena, Murcia, 30203, Spain

RECRUITING

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

NOT YET RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, Spain

NOT YET RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain

NOT YET RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

NOT YET RECRUITING

Hospital Universitario de La Princesa

Madrid, 28028, Spain

NOT YET RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, 28222, Spain

RECRUITING

Hospital Regional Univeristario de Málaga

Málaga, 29010, Spain

RECRUITING

Complexo Hospitalario Univeritario de Ourense

Ourense, 32005, Spain

RECRUITING

Hospital Universitari Son Espases

Palma de Mallorca, 07120, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

NOT YET RECRUITING

Complejo Hospitalario Universitario de Vigo

Vigo, 36204, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Antonio Ojeda, MD

CONTACT

0034911729144renased@sedolor.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2023

First Posted

March 15, 2023

Study Start

April 1, 2023

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

May 22, 2024

Record last verified: 2024-05

Locations

ES(16)