High-density in Spinal Cord Stimulation: Virtual Expert Registry (Discover)

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.

Study Overview

• Status: Completed
• Conditions: Failed Back Surgery Syndrome
• Intervention / Treatment: Device: spinal cord stimulation

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 Type: Observational
• Enrollment (Actual): 272

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium
    • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic back and leg pain (due to Failed Back Surgery Syndrome) who either received SCS or have not sufficient pain reduction with traditional parameters or patients with chronic back and leg pain who are candidate for SCS will receive HD SCS.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
spinal cord stimulation; Failed back surgery syndrome patients will receive high density spinal cord stimulation	Device: spinal cord stimulation; Other Names: high density spinal cord stimulation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Collaborators: Medtronic

Publications and helpful links

General Publications

• Song Z, Meyerson BA, Linderoth B. High-Frequency (1 kHz) Spinal Cord Stimulation-Is Pulse Shape Crucial for the Efficacy? A Pilot Study. Neuromodulation. 2015 Dec;18(8):714-20. doi: 10.1111/ner.12344. Epub 2015 Sep 6.
• Sweet J, Badjatiya A, Tan D, Miller J. Paresthesia-Free High-Density Spinal Cord Stimulation for Postlaminectomy Syndrome in a Prescreened Population: A Prospective Case Series. Neuromodulation. 2016 Apr;19(3):260-7. doi: 10.1111/ner.12357. Epub 2015 Oct 20.
• Goudman L, Rigoard P, Billot M, De Smedt A, Roulaud M, Consortium D, Moens M; Discover Consortium. Spinal Cord Stimulation-Naive Patients vs Patients With Failed Previous Experiences With Standard Spinal Cord Stimulation: Two Distinct Entities or One Population? Neuromodulation. 2023 Jan;26(1):157-163. doi: 10.1016/j.neurom.2022.04.037. Epub 2022 May 10.
• Goudman L, De Smedt A, Eldabe S, Rigoard P, Linderoth B, De Jaeger M, Moens M; Discover Consortium. High-dose spinal cord stimulation for patients with failed back surgery syndrome: a multicenter effectiveness and prediction study. Pain. 2021 Feb 1;162(2):582-590. doi: 10.1097/j.pain.0000000000002035.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): December 8, 2020
• Study Completion (Actual): December 8, 2020

Study Registration Dates

• First Submitted: May 26, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimate): June 1, 2016

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: High density spinal cord stimulation; Virtual expert registry
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Back Pain; Failed Back Surgery Syndrome
• Other Study ID Numbers: Discover1