Status:
RECRUITING
Mechanisms and Outcome-Prognostication for Paresthesia-based and -free Spinal Cord Stimulation
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
MSH-UHN AMO Innovation Fund
Conditions:
Neuropathic Pain
Chronic Pain
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 anal...
Detailed Description
Over 7 million Canadians suffer from chronic pain with 1 in 4 patients having neuropathic pain (NP), a condition caused by injury to nerves in the body. NP tends to have an extremely unpleasant charac...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03852381
Start Date
May 16 2019
End Date
December 31 2025
Last Update
December 6 2024
Active Locations (1)
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1
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8