Status:
COMPLETED
Prospective Randomized Feasibility Study Comparing Manual vs. Automatic Position-Adaptive Spinal Cord Stimulation With Surgical Leads
Lead Sponsor:
Justin Parker Neurological Institute
Conditions:
Chronic Refractory Low Back and Leg Pain
Eligibility:
All Genders
18-70 years
Brief Summary
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 t...
Detailed Description
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 RestoreSens...
Eligibility Criteria
Inclusion
- 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
- Previous SCS treatment
- Surgically remediable spinal condition
- Active local or systemic infection
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01874899
Start Date
June 1 2013
End Date
December 1 2017
Last Update
August 7 2019
Active Locations (1)
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1
Boulder Neurosurgical Associates
Boulder, Colorado, United States, 80302