Exploring new spinal cord stimulation methods for chronic pain relief
Mechanisms and Outcome-Prognostication for Paresthesia-based and -Free Spinal Cord Stimulation in Patients With Persistent Neuropathic Pain: the MOPPStim Study
This study is testing new ways of using spinal cord stimulation to see if they can help people with chronic pain feel better compared to traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT03852381 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of different spinal cord stimulation (SCS) methods, specifically comparing traditional paresthesia-based SCS with newer paresthesia-free SCS techniques. It aims to understand the mechanisms behind pain relief and identify which patients are most likely to benefit from these treatments. Participants will undergo neuroimaging and assessments to gather data on pain, physical activity, and sleep patterns. The study is designed to be prospective and exploratory, with randomization and blinding to ensure robust results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with refractory neuropathic pain following lumbar spine surgery.
Not a fit: Patients with previous spinal cord stimulation trials or those with certain medical contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management options for patients suffering from chronic neuropathic pain.
How similar studies have performed: While traditional spinal cord stimulation has been widely used, the newer paresthesia-free methods are relatively novel and have not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Toronto, Ontario
- Toronto Western Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Anuj Bhatia, MD FRCPC — University Health Network, Toronto
- Study coordinator: Anuj Bhatia, MD FRCPC
- Email: anuj.bhatia@uhn.ca
- Phone: (416) 603-5800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.