Status:

COMPLETED

Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO)

Lead Sponsor:

University of Aarhus

Collaborating Sponsors:

Aarhus University Hospital

CHU de Quebec-Universite Laval

Conditions:

Neuralgia

Spinal Cord Stimulation

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Spinal cord stimulation is a minimally invasive surgical treatment for severe, chronic, neuropathic pain that is refractory to conventional treatment. The treatment consists of an electrode implanted...

Detailed Description

In the post-hoc analysis the carryover and reverse carryover effect will be analyzed and correlated to a number of parameters including, but not limited to: Indication, treatment duration, symptom dur...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • patient age minimum 18 years
  • signed informed consent
  • implanted with full SCS system for neuropathic pain
  • SCS treatment duration minimum 6 months before inclusion
  • maximum pain score 7 or less on a 0-10 NRS at the area of pain treated with SCS during the last 48 hours before study-related deactivation of the device
  • Exclusion Criteria
  • any surgical SCS lead revision for the last 6 months before inclusion
  • any changes in the programming patterns of the device (except patient-controlled changes in amplitude) for a minimum of 30 days before the study-related deactivation of the device
  • any other ongoing neuromodulatory treatment (PNS, TENS, etc.)
  • any other neuromodulatory treatment with lasting effect (RFA, sympathectomy, infiltration anesthesia, nerve blockade) within the last 60 days
  • any changes in analgetic medication within the last 30 days (pn. dosings are allowed)

Exclusion

    Key Trial Info

    Start Date :

    January 31 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 30 2021

    Estimated Enrollment :

    200 Patients enrolled

    Trial Details

    Trial ID

    NCT03386058

    Start Date

    January 31 2018

    End Date

    March 30 2021

    Last Update

    May 13 2021

    Active Locations (10)

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    Page 1 of 3 (10 locations)

    1

    AZ Delta Roeselare/Menen/Torhout

    Roeselare, Belgium, 8800

    2

    CHU de Québec - Université Laval

    Québec, Quebec, Canada, G1J 1Z6

    3

    Aalborg University Hospital

    Aalborg, Denmark, 9000

    4

    Aarhus University Hospital

    Aarhus, Denmark, 8000