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The main purpose of this study is to establish the extent that chronic pain patients implanted with surgical, laminectomy-type, leads experience position-related variation in spinal cord stimulation therapy and to investigate the effects of manual versus automatic position-adaptive spinal cord stimulation on clinical outcome.
A single-center, prospective, randomized study with a two-arm crossover design. The primary objective of this study is to establish threshold and therapeutic stimulation parameters for the RestoreSensor neurostimulator in response to postural changes. The secondary objective is to compare the effectiveness of spinal cord stimulation with manual versus automatic position-adaptive settings for chronic refractory low back and/or extremity pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual, then Automatic Stimulation | The RestoreSensor neurostimulator will be programed for manual stimulation adjustments and the patients will crossover to automatic stimulation group after 1.5 months |
| |
| Automatic, then Manual Stimulation | The RestoreSensor neurostimulator will be programed for automatic stimulation adjustments and the patients will crossover to manual stimulation group after 1.5 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RestoreSensor Neurostimulation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stimulation amplitude changes in response to postural changes | Threshold and therapeutic stimulation parameters in different postures: lying right, lying left, lying prone, lying supine, upright and upright active will be collected for manual and sensor-driven position-adaptive stimulation. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality improvement | Pittsburg Sleep Quality Index Oswestry Disability Index | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disability score improvement | Oswestry Disability Index | 6 months |
| Pain scores | Numeric pain scale | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with chronic refractory back and leg pain associated with failed back surgery syndrome, post-laminectomy pain, radicular pain syndrome or radiculopathy refractory to conservative and surgical interventions.
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| Name | Affiliation | Role |
|---|---|---|
| Kara Beasley, DO | Boulder Neurosurgical Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boulder Neurosurgical Associates | Boulder | Colorado | 80302 | United States |
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| Patient satisfaction | Likert scale | 6 months |