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

Completed

Conditions studied: Chronic Refractory Low Back and Leg Pain

In brief

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.

Key facts

Study ID

NCT01874899

Run by

Justin Parker Neurological Institute

People needed

18

Starts

2013-06-01

Expected to finish

2017-12-01

Last updated by the study team

2019-08-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Previous SCS treatment
• Surgically remediable spinal condition
• Active local or systemic infection

Where it is running

• Boulder Neurosurgical Associates — Boulder, Colorado, United States

Full record on ClinicalTrials.gov

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