Prospective Randomized Feasibility Study Comparing Manual vs. Automatic Position-Adaptive Spinal Cord Stimulation With Surgical Leads
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Refractory Low Back and Leg Pain
- Sponsor
- Justin Parker Neurological Institute
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Stimulation amplitude changes in response to postural changes
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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 therapy and to investigate the effects of manual versus automatic position-adaptive spinal cord stimulation on clinical outcome.
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 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.
Investigators
Alan T. Villavicencio, MD
Principle Investigator
Justin Parker Neurological Institute
Eligibility Criteria
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
Outcomes
Primary Outcomes
Stimulation amplitude changes in response to postural changes
Time Frame: 6 months
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.
Secondary Outcomes
- Sleep quality improvement(6 months)