Prospective Randomized Feasibility Study Comparing Manual vs. Automatic Position-Adaptive Spinal Cord Stimulation With Surgical Leads
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | June 2013 |
| End Date: | June 2016 |
| Contact: | Sigita Burneikiene |
| Email: | sigitab@bnasurg.com |
| Phone: | 303-938-5700 |
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.
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.
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.
Inclusion Criteria:
- Skeletally mature adults between 18 and 70 years old
- Patients with chronic refractory back and/or leg pain associated with failed back
surgery syndrome, post-laminectomy pain, radicular pain syndrome or radiculopathy
refractory to conservative and surgical interventions
- > 50% pain reduction during the trail period
- Willing and able to comply with the requirements of the protocol including follow-up
requirements
- Willing to sign a study specific informed consent
Exclusion Criteria:
- Previous SCS treatment
- Surgically remediable spinal condition
- Active local or systemic infection
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