High-density in Spinal Cord Stimulation: Virtual Expert Registry

Completed

• Conditions: Failed Back Surgery Syndrome
• Interventions: Device: spinal cord stimulation

• Registration Number: NCT02787265
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

This is a prospective, multi-center, observational follow-up study observing the effectiveness of high density spinal cord stimulation in patients with failed back surgery syndrome patients with back and leg pain.

Detailed Description

DISCOVER will measure the effectiveness of high-density spinal cord stimulation for treatment of chronic back and leg pain. Identification of clinical effective parameters concerning location of active electrodes, frequency, pulse duration, amplitude and battery consumption are, besides safety, the major outcome parameters of this study.

Study Timeline

• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-05-26
• Study Start: 2016-06
• Study First Posted: 2016-06-01
• Primary Completion: 2020-12-08
• Study Completion: 2020-12-08
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

• Failed Back Surgery Syndrome patients (FBSS) with insufficient pain reduction with conventional SCS or FBSS patients suitable for SCS
• Age > 18 years
• Chronic pain as a result of FBSS that exists for at least 6 months with a pain intensity 5 or higher measured on numeric rating scale (NRS)
• Patient has been informed of the study procedures and has given written informed consent
• Patient willing to comply with study protocol including attending the study visits

Exclusion Criteria

• Expected inability of patients to receive or properly operate the spinal cord stimulation system
• History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
• Active malignancy
• Addiction to any of the following drugs, alcohol (5E/day) and/or medication
• Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
• Immune deficiency (HIV positive, immunosuppressiva, etc.)
• Life expectancy < 1 year
• Local infection or other skin disorder at site of incision
• Pregnancy
• Other implanted active medical device

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
spinal cord stimulation	spinal cord stimulation	Failed back surgery syndrome patients will receive high density spinal cord stimulation

Primary Outcome Measures

Name	Time	Method
Pain relief by pain medication	The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.	Questionnaire regarding the amount of pain relief by pain medication
The current health status	The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.	The health status will be observed with the Euroqol (EQ-5D-5L) questionnaire.
Pain intensity with the Numeric Rating Scale (NRS)	The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
The abilities in daily living	The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.	The functional abilities will be assessed with the Oswestry Low Back Pain Questionnaire.
Patient's satisfaction	The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.	Patient's satisfaction with the stimulation will be assessed with a 5 item Likert scale
Subjective sleep quality	The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.	Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).

Secondary Outcome Measures

Name	Time	Method
Battery efficiency of the neurostimulator	The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.	The battery usage will be measured by frequencies to recharge the battery.
Pain area coverage	The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.	The patient has to draw the areas of pain coverage on a body shape figure
HD stim parameters	The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.	Questionnaire towards the clinician regarding the ideal high density parameters for this patient
AdaptiveStim use (in case of Restore Sensor)	The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.	Acquire information on activity from the internal diary; amount of times that patients need to fit the ideal parameters themselves
Paresthesia threshold	The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.	Patient indicates the threshold at which he experiences paresthesia
MRI need	The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.	Questionnaire regarding the need for MR scans for other medical conditions

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Brussel, Belgium