Phase
Condition
Pain
Chronic Pain
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18 years of age or older
- Willing and able to provide signed and dated informed consent
- Capable of comprehending and consenting in English
- Candidate per labeling for an SCS system as an aid in the management of chronic,intractable pain of the trunk and/or limbs
- Has moderate to severe back and leg pain
- Stable pain medications for back and leg pain for at least 28 days prior to enrollment
- Willing and able to comply with all study procedures and visits
- Willing and able to not increase their pain medications through the 3-Month visit
- Able to differentiate between pain associated with the indication for SCS implant andother types of pain
Exclusion
Exclusion Criteria:
- Previously trialed or implanted with a stimulator or intrathecal drug delivery system
- Expected to be inaccessible for follow-up
- Current diagnosis of moderate to severe central lumbar spinal stenosis withsymptomatic neurogenic claudication
- Currently enrolled or planning to enroll in an interventional clinical study thatcould potentially confound the study results
- If female, is pregnant or is of child-bearing potential and unwilling to use amedically acceptable form of birth control during the study
- Has untreated major psychiatric comorbidity
- Serious drug-related behavioral issues
- Unable to achieve supine or prone position
- Classified as vulnerable or requires a legally authorized representative (LAR)
Study Design
Study Description
Connect with a study center
IPM Medical Group
Walnut Creek, California 94598
United StatesSite Not Available
Goodman Campbell Brain and Spine
Carmel, Indiana 46032
United StatesSite Not Available
Drez One LLC
Somerset, Kentucky 42503
United StatesSite Not Available
Cell Bionics Institute
Utica, New York 13502
United StatesSite Not Available
Carolinas Pain Center
Huntersville, North Carolina 28078
United StatesSite Not Available
Novant Health
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Oklahoma Pain Physicians
Oklahoma City, Oklahoma 73120
United StatesSite Not Available
Center for Interventional Pain and Spine
Lancaster, Pennsylvania 17604
United StatesSite Not Available
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania 15143
United StatesSite Not Available
Delaware Valley Pain and Spine Institute
Trevose, Pennsylvania 19053
United StatesSite Not Available
The Woodlands Pain Institute
Conroe, Texas 77384
United StatesSite Not Available
The Burkhart Research Institute for Orthopaedics
San Antonio, Texas 78216
United StatesSite Not Available
Sprintz Center for Pain
Shenandoah, Texas 77384
United StatesSite Not Available
Precision Spine Care
Tyler, Texas 75701
United StatesSite Not Available

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