Study Protocol: Single-Blinded, Controlled, Clinical Trial Evaluating the Feasibility of Spinal Cord Stimulation for Improving Neuropathic Pain and Rehabilitation Outcomes in Patients With Thoracic Spinal Cord Injury.
BACKGROUND AND OBJECTIVES: Traumatic thoracic spinal cord injury (SCI) is complicated by chronic neuropathic pain and neurological deficits including bowel and bladder dysfunction. Treatment with spinal cord stimulation (SCS) has demonstrated possible utility in previous observational studies. In this article, we discuss the protocol for an actively enrolling, NIH-funded clinical trial investigating the use of dual lead (thoracic and conus medullaris) SCS as a possible treatment of SCI. METHODS: The clinical trial is a single-blinded, 2-arm parallel study for patients with a history of chronic neuropathic pain after thoracic SCI. Patients are allocated 1:1 to SCS "on" or SCS "off" to which they are formally blinded for 3 months. At 3 months, a 1-way crossover will occur. The primary outcome is the change in the Pain Impact Score of the Multidimensional Pain Inventory-SCI from baseline to 3 months. Secondary outcomes include the changes in electromyography amplitudes, motor and sensory American Spinal Injury Association scores, functional status using the spinal cord independence measure, Visual Analog Scale for pain, active medication use, Patient Global Impression of Change scale, quality of life, bladder control diaries, and harness-supported walking. As the trial is ongoing, data are not yet available for public access. Details regarding data access will be provided in the subsequent publication. EXPECTED OUTCOMES: We expect to see differential improvements in the Pain Impact Score of the Multidimensional Pain Inventory-SCI, motor and sensory American Spinal Injury Association score, Visual Analog Scale, spinal cord independence measure, and Patient Global Impression of Change in the initial "on" vs "off" groups at 3, 6, 9, and 12 months. DISCUSSION: Dual lead SCS may serve as a safe and viable treatment option for patients living with SCI. We anticipate patients who undergo SCS to have improved neuropathic pain and neurological function, with greater improvement in patients receiving longer SCS.
