OPTIONS Spinal Cord Stimulation Programming Parameters

Completed · Not applicable

Conditions studied: Pain, Intractable

In brief

The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.

Key facts

Study ID

NCT02503787

Run by

MedtronicNeuro

People needed

64

Starts

2015-07-01

Expected to finish

2016-08-01

Last updated by the study team

2017-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Candidate for Spinal Cord Stimulation (SCS) system (trial and implant) per labeled indication(back and leg pain)
• Willing and able to provide a signed and dated informed consent
• At least 18 years old at the time of informed consent
• Willing and able to attend visits and comply with the study protocol
• Capable of using the patient programmer and recharging the neurostimulator
• Willing to not increase pain medications from baseline through the 3-Month Visit

You may not qualify if…

• Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound study results.
• Psychological or other health conditions that would interfere with the subject's ability to fulfill the requirements of the protocol.
• Trialed or implanted with SCS, subcutaneous stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
• Implanted with a cardiac device (e.g., pacemaker, defibrillator)

Where it is running

• Valley Pain Consultants-North Scottsdale — Scottsdale, Arizona, United States
• Synovation Medical Group — Chula Vista, California, United States
• Center for Interventional Pain Spine — Wilmington, Delaware, United States
• Pain Care LLC — Stockbridge, Georgia, United States
• Millennium Pain Center — Bloomington, Illinois, United States
• The Center for Clinical Research — Winston-Salem, North Carolina, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• St. Luke's Neurosurgical Associates — Bethlehem, Pennsylvania, United States
• Precision Spine Care — Tyler, Texas, United States
• Swedish Pain Services — Seattle, Washington, United States
• Northwest Pain Care — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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