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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Refractory Low Back and Leg Pain

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

RestoreSensor Neurostimulation

Intervention Type DEVICE

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.

RestoreSensor Neurostimulation

Intervention Type DEVICE

Interventions

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RestoreSensor Neurostimulation

Intervention Type DEVICE

Eligibility Criteria

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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