Prospective Randomized Feasibility Study Comparing Manual vs. Automatic Position-Adaptive Spinal Cord Stimulation With Surgical Leads

Justin Parker Neurological Institute18 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Refractory Low Back and Leg Pain

Interventions

RestoreSensor NeurostimulationDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Boulder Neurosurgical Associates

Boulder, Colorado, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

Sleep quality improvement

Pittsburg Sleep Quality Index Oswestry Disability Index

Time frame: 6 months

Data from ClinicalTrials.gov

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