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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DL-SCS Only | Experimental | The DL-SCS electrode will be activated with a high-frequency paresthesia-free program. |
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| Stimulation Off | Placebo Comparator | Both electrodes will be programmed for sham stimulation. |
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| M-SCS Only | Experimental | The M-SCS electrode will be activated with a high-frequency, paresthesia free program. |
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| DL-SCS + M-SCS | Experimental | Both DL-SCS and M-SCS will be activated with high-frequency, paresthesia free programs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulator | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery |
| Change in score on EuroQol 5 Dimension Questionnaire |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lutz Weise, MD, PhD | Contact | 902-472-6850 | ally.klassen@nshealth.ca |
| Name | Affiliation | Role |
|---|---|---|
| Lutz Weise, MD, PhD | Nova Scotia Health Authority | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Health Science Centre | Halifax | Nova Scotia | B3H 3A7 | Canada |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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This study will be conducted as a placebo-controlled, crossover, randomized clinical trial of the intervention dorsolateral spinal cord stimulation (DL-SCS) for the indication post-surgical focal neuropathic pain. Study arm order will be randomly generated and known only to the programmer. Once participants have crossed over into all study arms, they will be set on their best program and enter long-term observation.
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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. |
| 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. | 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. | Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery |
| Change in score on the 12-item Short Form Survey | 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. | Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |