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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
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.
Queen Elizabeth Health Science Centre
Halifax, Nova Scotia, Canada
Change from baseline on the Numerical Rating Scale (NRS) for pain intensity
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.
Time frame: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
Change in score on Oswestry Disability Index
Assesses a patient's quality of life in relation to back pain on a 10-section questionnaire. A low score indicates no disability and a high score indicates severe disability.
Time frame: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
Change in score on EuroQol 5 Dimension Questionnaire
Assesses overall quality of life in five dimensions including mobility, self-care, daily routine, pain, and anxiety/depression. A low score indicates poor health and a high score indicates excellent health.
Time frame: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
Change in morphine equivalents used
Measures patient pain by assessing the amount of pain medication taken by a patient. Higher usage indicates a greater level of pain and a lower usage indicates a lower level of pain.
Time frame: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
Change in score on the Brief Pain Inventory Short Form
Assesses the impact of pain on a patient's quality of life. A high score indicates a severe impact and a lower score indicates minimal impact.
Time frame: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
Change in score on the 12-item Short Form Survey
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Assesses how a patient's health impacts their quality of life. A higher score indicates a better quality of life, and a low score indicates a poorer quality of life.
Time frame: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery