Midline Versus Dorsolateral Spinal Cord Stimulation for Post-surgical Neuropathic Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spinal Cord Stimulator.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative, Neuropathic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Midline Versus Dorsolateral Spinal Cord Stimulation for Post-surgical Neuropathic Pain (MIDL-SCS Trial)
Overview
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.
Interventions
- Device Spinal Cord Stimulator
The spinal cord stimulator is an implantable pulse generator connected to electrodes with leads that stimulate the spinal cord. The device is programmed to deliver therapeutic stimulation to treat pain.
Primary outcome measures
- 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]
Secondary outcome measures (5)
- Change in score on Oswestry Disability Index [Time frame: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery]
- Change in score on EuroQol 5 Dimension Questionnaire [Time frame: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery]
- Change in morphine equivalents used [Time frame: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery]
- Change in score on the Brief Pain Inventory Short Form [Time frame: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery]
- Change in score on the 12-item Short Form Survey [Time frame: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery]
Eligibility criteria
Inclusion criteria
- Diagnosis of neuropathic pain following a surgical procedure
- A minimum of 50% of pain should be limited to one body part, defined as one limb or one side of trunk.
- Failed conservative therapies (medication, physiotherapy)
- Disability more than 6 months
Exclusion criteria
- Previous implantation with SCS (i.e. revision surgery)
- Any underlying condition that would preclude an MRI
- Untreated psychiatric conditions or substance use disorder
- Existing medical conditions that would preclude from SCS (history of recurrent infections, uncontrolled cancer, etc.)
- Surgically treatable lesion (e.g. spinal stenosis, disc herniation)
- Lack of capacity (e.g. significant cognitive impairment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Queen Elizabeth Health Science Centre — Halifax
Identifiers
NCT: NCT06390150 · MIDL-SCS