Midline Versus Dorsolateral Spinal Cord Stimulation for Post-surgical Neuropathic Pain (MIDL-SCS Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain, Postoperative
- Sponsor
- Nova Scotia Health Authority
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change from baseline on the Numerical Rating Scale (NRS) for pain intensity
- Status
- Not yet recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
The goal of this interventional study is to learn if dorsolateral spinal cord stimulation (DL-SCS) can treat focal post-surgical, medically refractory neuropathic pain. The main question it aims to answer is:
- How does DL-SCS compare to traditional SCS and no treatment for treating post-surgical neuropathic pain?
Participants will be asked to
- trial combinations of stimulation across blocks of weeks (randomized cross-over)
- rate their pain after each stimulation trial
Detailed Description
Neuropathic pain resulting from injury to the somatosensory nervous system can be a persistent and debilitating condition of spontaneous and unprovoked symptoms. For patients with chronic neuropathic pain that does not respond to conservative therapy, spinal cord stimulation (SCS) may be considered. SCS has been established as an effective and sustained treatment for neuropathic pain, but may deliver treatment to more than just the pain area. Dorsolateral spinal cord stimulation (DL-SCS) may provide a more focal alternate target for spinal stimulation. The aim of this study is to investigate DL-SCS as a therapeutic option for post-surgical, medically refractory neuropathic pain. This is a prospective, randomized, double-blind controlled crossover trial to investigate the efficacy of DL-SCS and midline SCS (M-SCS) compared to sham stimulation for the diagnosis of post-surgical neuropathic pain. Each participant will be implanted with two electrodes and will crossover into each stimulation program in a randomized order to serve as their own control.
Investigators
Lutz Weise
Principal Investigator
Nova Scotia Health Authority
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change from baseline on the Numerical Rating Scale (NRS) for pain intensity
Time Frame: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
The primary outcome is the self-reported difference in change from baseline of the severity of pain quantified in the Numerical Rating Scale. This will be assessed at baseline (pre-surgery) and at regular follow-up appointments.
Secondary Outcomes
- Change in score on the Brief Pain Inventory Short Form(Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery)
- Change in score on Oswestry Disability Index(Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery)
- Change in score on EuroQol 5 Dimension Questionnaire(Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery)
- Change in score on the 12-item Short Form Survey(Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery)
- Change in morphine equivalents used(Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery)