Medtronic Virgin-Back Study
Research type
Research Study
Full title
A prospective open label pilot study to investigate the response to changes in frequency parameters and measure the variable electrode array response with Medtronic Restore Sensor technology in patients with intractable neuropathic pain who have not had spinal surgery.
IRAS ID
209520
Contact name
Vivek Mehta
Contact email
Sponsor organisation
Barts Health NHS Trust
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
Traditionally, spinal cord stimulation (SCS) has been used for patients with chronic neuropathic pain following back\nsurgery (a condition known as Failed Back Surgery Syndrome (FBSS)). Although the National Institute for Health and\nCare Excellence (NICE) also recommends SCS for chronic neuropathic pain without previous back surgery, clinical\noutcome data is much needed in this patient group. Conventionally, patients receiving SCS are provided with tonic\nstimulation settings (where they feel tingling and paraesthesia); however newer methods include high-density\nstimulation (HD) that provides higher energy allowing the voltage to be reduced to subthreshold parameters, hence\nminimizing the tingling and paraesthesia. HD stimulation is widely offered to patients with SCS as part of routine\nclinical practice, although no known studies have yet investigated HD settings in patients with neuropathic pain without\nprevious spinal surgery. Therefore, the purpose of this study is to determine the effectiveness of HD settings in\npatients without previous spinal surgery undergoing SCS. 20 patients without previous spinal surgery who are\ndeemed suitable for SCS as part of NICE guidelines 159 pathway will be recruited for the study.\nAll patients have a trial of SCS where they will be offered HD settings. If successful (>50% improvement in pain\nscores) they will be offered permanent implant. Those patients whose pain does not improve with HD settings will be\nfurther offered conventional tonic stimulation for one more week. Those patients who do not respond to both tonic and\nHD settings will be excluded and will not have permanent implant. This will also allow us to investigate the patient’s\npreference between the HD neurostimulator settings and conventional tonic settings. We will also investigate the\nresponse to these stimulator settings on health related quality of life.\n
REC name
London - Hampstead Research Ethics Committee
REC reference
17/LO/0044
Date of REC Opinion
25 Jan 2017
REC opinion
Favourable Opinion