Neuropathic Pain study: Spinal Cord Stimulation
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
- This study is looking at how spinal cord stimulation helps with pain. It also aims to find the best way to pick patients for this treatment.
- Who it's for
- You may be able to join if you have chronic nerve pain.
- What's involved
- You would get spinal cord stimulation (a device that sends signals to your spine). You would also have brain scans and pain checks.
- Time commitment
- The source text does not say how long the study lasts or how many visits are needed.
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 is enrolling
- 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, but 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?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.