Mechanisms and Outcome-Prognostication for Paresthesia-based and -Free Spinal Cord Stimulation (MOPPStim)
Neuropathic Pain, Chronic Pain
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring Spinal Cord Stimulation, Burst Stimulation, High Frequency Stimulation, High Density Stimulation, fMRI, MEG, QST
Eligibility Criteria
Inclusion Criteria:
- Adults, 18 - 80 years of age, with refractory neuropathic pain (as per clinical features and DN4 score > 3/10) in back and or lower limbs for more than 3 months following lumbar spine surgery
- Severity of pain > 3/10 on NRS and ODI score for disability >40/100; and
- Pain refractory to conventional medical management tried for at least 3 months.
Exclusion Criteria:
- Age < 18 or age ≥ 80 years;
- Previous trial or implantation of SCS system;
- Procedural contraindications to SCS including extensive thoracolumbar spine surgery, moderate-to-severe central canal stenosis, coagulopathy, local or systemic infection;
- Pregnancy;
- Opioid dose > 200 mg OMED;
- Psychiatric or psychological disorder likely to impact perception of pain;
- Inability to comply with the study interventions or evaluate treatment outcomes;
- Mechanical spine instability as per flexion/extension lumbar X-rays;
- Ongoing litigation issues related to the pain; and
- Concomitant peripheral neuropathy or myopathy or central neuropathic pain (e.g. post-stroke pain).
Sites / Locations
- Toronto Western HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Spinal Cord Stimulation
At baseline, the following data will be recorded: standard-of-care questionnaire scores, neuroimaging (fMRI, MEG), psychophysical testing (QST), accelerometer sleep and activity data. The trial will proceed as follows: Day 1-4: Paresthesia-based SCS (PB-SCS) Day 5-8: No SCS (placebo) Day 9-12: PF-SCS Neuroimaging and psychophysical testing will be conducted at the end of the trial, and will be assessed 6-months post-implantation of the SCS device along with adverse effects. A decision to implant the SCS system will be made based on reduction of patient pain intensity by 50% in PB-SCS and/or PF-SCS modes, but not with placebo SCS. Based on the response in the trial, the patient will either not be a candidate for an SCS implant, or they will receive one of the four modes upon implantation (PB-SCS, or one of the three PF-SCS: Burst, High Frequency, High Density).