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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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