Exploring new spinal cord stimulation methods for chronic pain relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.