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New treatment option for Neuropathic Pain
Official title Mechanisms and Outcome-Prognostication for Paresthesia-based and -Free Spinal Cord Stimulation
ClinicalTrials.gov ID: NCT03852381
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Pregnancy;
- Opioid dose \> 200 mg OMED;
- Psychiatric or psychological disorder likely to impact perception of pain;
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.