Spinal Cord Stimulation for Chronic Pain
(MOPPStim Trial)
Trial Summary
What is the purpose of this trial?
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. Recently introduced three different paresthesia-free (PF-SCS) modes of stimulation aim to overcome limitations of PB-SCS. Several questions regarding PB and PF SCS modes remain unanswered including the mechanisms of therapeutic benefit, criteria for selecting patients likely to benefit, and long-term outcomes. A concerted effort is required to understand and optimize utilization of SCS. This project has the twin goals of using neuroimaging techniques to understand mechanisms that underlies analgesic benefit from PB/PF-SCS modes and to identify criteria for selecting patients based on monitoring of pain and its related domains in patients undergoing SCS trials. Achieving these objectives will increase probability of analgesic benefit while minimizing adverse effects and knowledge gains from this study will be applicable to other therapies for chronic pain conditions.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that your pain should be refractory (not responding) to conventional medical management tried for at least 3 months, which suggests you may continue your current medications if they are not effective.
What data supports the effectiveness of the treatment Spinal Cord Stimulation for Chronic Pain?
Research shows that spinal cord stimulation (SCS) has been effective in managing chronic pain, especially neuropathic pain (pain from nerve damage), with many patients experiencing long-term relief. Additionally, transcutaneous spinal cord stimulation (tSCS) has been used to aid motor recovery in spinal cord injury patients, suggesting its potential in modulating nerve activity.12345
Is spinal cord stimulation safe for humans?
How is spinal cord stimulation different from other treatments for chronic pain?
Spinal cord stimulation (SCS) is unique because it uses electrical impulses to alter pain signals before they reach the brain, which can be done through implanted electrodes (epidural) or non-invasive methods (transcutaneous). This approach is different from medications or surgeries, as it directly targets the spinal cord to manage pain without the need for drugs or destructive procedures.1341011
Research Team
Anuj Bhatia, MD FRCPC
Principal Investigator
University Health Network, Toronto
Eligibility Criteria
This trial is for adults aged 18-80 with chronic neuropathic pain in the back or lower limbs following lumbar spine surgery, which hasn't improved after at least 3 months of treatment. Participants should have a pain severity over 3/10 and disability score over 40/100. It's not for those with certain psychiatric conditions, pregnant women, people unable to follow the study protocol, spinal instability on X-rays, ongoing litigation related to their pain, other types of neuropathy or myopathy, previous SCS trials or implants.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
SCS Trial
Participants undergo a percutaneous trial of SCS with different modes: PB-SCS, placebo, and PF-SCS
Post-Trial Assessment
Neuroimaging and psychophysical testing conducted at the end of the SCS trial
Implantation and Follow-up
Participants who respond well to the trial receive SCS implantation and are monitored for 6 months
Treatment Details
Interventions
- Spinal Cord Stimulation
Spinal Cord Stimulation is already approved in United States, European Union, Canada for the following indications:
- Failed back surgery syndrome (FBSS)
- Adhesive arachnoiditis
- Peripheral causalgia/neuropathy
- Reflex sympathetic dystrophy (RSD)
- Phantom limb/stump pain
- Ischemic pain of vascular origin
- Complex regional pain syndrome
- Pain after an amputation
- Visceral abdominal pain and perineal pain
- Chronic pain
- Neuropathic pain
- Spinal cord injury pain
- Failed back surgery syndrome (FBSS)
- Adhesive arachnoiditis
- Peripheral causalgia/neuropathy
- Reflex sympathetic dystrophy (RSD)
- Chronic pain
- Neuropathic pain
- Spinal cord injury pain
- Failed back surgery syndrome (FBSS)
- Adhesive arachnoiditis
- Peripheral causalgia/neuropathy
- Reflex sympathetic dystrophy (RSD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
MSH-UHN AMO Innovation Fund
Collaborator