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Mechanisms and Outcome-Prognostication for Paresthesia-based and -Free Spinal Cord Stimulation

RecruitingNAAges 18 Years - 80 YearsAllUniversity Health Network, Toronto
NCT03852381 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Spinal cord stimulation (SCS) relies on stimulation of pain-relieving pathways in the spinal cord to treat chronic neuropathic pain. Traditional paresthesia-based SCS (PB-SCS) relies on providing analgesia through stimulation of spinal cord dorsal columns but it is often associated with attenuation of analgesic benefit and lack of acceptance of paresthesias. Recently introduced three different paresthesia-free (PF-SCS) modes of stimulation aim to overcome limitations of PB-SCS. Several questions regarding PB and PF SCS modes remain unanswered including the mechanisms of therapeutic benefit, criteria for selecting patients likely to benefit, and long-term outcomes. A concerted effort is required to understand and optimize utilization of SCS. This project has the twin goals of using neuroimaging techniques to understand mechanisms that underlies analgesic benefit from PB/PF-SCS modes and t

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. 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 2. Severity of pain \> 3/10 on NRS and ODI score for disability \>40/100; and 3. Pain refractory to conventional medical management tried for at least 3 months. Exclusion Criteria: 1. Age \< 18 or age ≥ 80 years; 2. Previous trial or implantation of SCS system; 3. Procedural contraindications to SCS including extensive thoracolumbar spine surgery, moderate-to-severe central canal stenosis, coagulopathy, local or systemic infection; 4. Pregnancy; 5. Opioid dose \> 200 mg OMED; 6. Psychiatric or psychological disorder likely to impact perception of pain; 7. Inability to comply with the study interventions or evaluate treatment outcomes; 8. Mechanical spine instability as per flexion/extension lumbar X-rays; 9. Ongoing litigation issues related to the pain; and 10. Concomitant peripheral neuropathy or myopathy or central neuropathic pain (e.g. post-stroke pain).
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What it tests

  • Spinal Cord Stimulation
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Where

1 site
Toronto Western Hospital
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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