Clinical trial NCT02787265: High-density in Spinal Cord Stimulation: Virtual Expert Registry
Official title: High-density in Spinal Cord Stimulation: Virtual Expert Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Failed Back Surgery Syndrome
Keywords: High density spinal cord stimulation
Virtual expert registry
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2016-06-01
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity with the Numeric Rating Scale (NRS)
timeFrame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
measure: Pain relief by pain medication
timeFrame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
measure: The abilities in daily living
timeFrame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
measure: The current health status
timeFrame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
measure: Subjective sleep quality
timeFrame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
measure: Patient's satisfaction
timeFrame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Secondary outcomes:
measure: Pain area coverage
timeFrame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
measure: Paresthesia threshold
timeFrame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
measure: HD stim parameters
timeFrame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
measure: Battery efficiency of the neurostimulator
timeFrame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
measure: AdaptiveStim use (in case of Restore Sensor)
timeFrame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
measure: MRI need
timeFrame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.