Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity

Study Overview
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Brief Summary
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The primary objective of this study is to compare the efficacy and patient preference for spinal cord stimulation (SCS) using the Precision device with the electrode array placed at T7 versus placement at T8. Eligible patients will have chronic intractable pain in the back or lower extremities and will have independently elected SCS as the next line of therapy. There is some anecdotal evidence that the coverage of the paresthesia resulting from T7 placement is preferable to that obtained by the more commonly used T8 placement but there has been no study to support this observation.

Detailed Description
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The conventional implantation of the spinal cord stimulator calls for dual percutaneous leads placed at T8-T9 vertebral levels. Recently published studies as outlined in a letter to the editor of Neuromodulation suggest that a well placed single lead will generally perform better than a dual lead. Furthermore, anecdotal reports suggest that lead placement at T7 will capture axial back pain with greater success compared to lead placement at alternative sites. This study aims to achieve better pain treatment and paresthesia coverage by placing a single lead at T7.

Official Title
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Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity: A Comparison of Electrode Placement at T7 and T8

Conditions
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Intractable Neuropathic Pain, Pain, Back Pain, Lower Extremity Pain

Intervention / Treatment
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* Device: Precision for Spinal Cord Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be diagnosed with chronic intractable neuropathic pain of moderate to severe intensity of the back or lower extremity and meeting the criteria for post-laminectomy syndrome, be eligible for SCS, and have independently elected SCS as next line of therapy. Be 18 years of age or older. Be willing and able to comply with all study related procedures and visits. Be capable of reading and understanding patient information materials and giving written informed consent. Exclusion Criteria: Have sensory loss in the low back or lower extremity as the primary complaint. Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints. Have participated in any investigational drug or device trial in the last 4 weeks or plan to participate in any other study during the year.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Stimulation will occur at the T7 followed by T8 during the trial implant period | Device: Precision for Spinal Cord Stimulation<br>* During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on.<br>|
| Active Comparator: 2<br>Stimulation will occur at the T8 followed by T7 during the trial implant period | Device: Precision for Spinal Cord Stimulation<br>* During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Efficacy Endpoint is Pain Severity After Trial Stimulation. |  | End of trial (approximately 5 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Chronic Pain, Neurostimulation