DTM (TM) Spinal Cord Stimulation (SCS) Study

Not Applicable

Completed

Brief Summary: Prospective, multi-center, open-label, post-market study to evaluate the efficacy and energy use of a low energy DTM™ (DTM-LE) SCS therapy for pain relief.

Detailed Description: This post market study will measure the following:

* Visual Analog Scale

* Programming Parameters

Recruitment & Eligibility

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 and other types of pain

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 with symptomatic neurogenic claudication
Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results
If female, is pregnant or is of child-bearing potential and unwilling to use a medically 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)

Arm && Interventions

Group	Intervention	Description
Spinal Cord Stimulation	Spinal Cord Stimulation System	Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	Baseline to 3 Months	To characterize changes in overall (back and leg) pain intensity. Pain will be assessed using a VAS (0-10 cm) with 0 cm meaning "no pain" and 10 cm meaning "worst pain imaginable". Overall pain is defined as a combination of back and leg pain, but not pain from other body parts. Subjects will be asked to report their average pain intensity that is related to their SCS device treatment "in the last 24 hours" by marking a line perpendicular to the VAS line at the point that represents their pain intensity.

Secondary Outcome Measures

Name	Time	Method
Programming Parameters: Pulse Width in Microseconds (µs)	12 Month	To characterize programming parameters associated with energy use. Subject's programmed Pulse Width settings will be summarized using the minimum and maximum Pulse Width across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.
Programming Parameters: Amplitude (Intensity) in Milliamp (mA)	12 Month	To characterize programming parameters associated with energy use. Subject's programmed Amplitude settings will be summarized using the minimum and maximum Amplitude across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.
Programming Parameters: Impedance Range in Ohms	12 Month	To characterize programming parameters associated with energy use. Subject's programmed Impedance settings will be summarized using the minimum and maximum Impedance across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.
Programming Parameters: Frequency in Hertz (Hz)	12 Month	To characterize programming parameters associated with energy use. Subject's programmed frequency settings will be summarized using the minimum and maximum frequency across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.

Locations (13): IPM Medical Group
🇺🇸
Walnut Creek, California, United States
Drez One LLC
🇺🇸
Somerset, Kentucky, United States
Goodman Campbell Brain and Spine
🇺🇸
Carmel, Indiana, United States
Novant Health
🇺🇸
Winston-Salem, North Carolina, United States
Oklahoma Pain Physicians
🇺🇸
Oklahoma City, Oklahoma, United States
Carolinas Pain Center
🇺🇸
Huntersville, North Carolina, United States
The Woodlands Pain Institute
🇺🇸
Conroe, Texas, United States
Pain Diagnostics and Interventional Care
🇺🇸
Sewickley, Pennsylvania, United States
Center for Interventional Pain and Spine
🇺🇸
Lancaster, Pennsylvania, United States
Delaware Valley Pain and Spine Institute
🇺🇸
Trevose, Pennsylvania, United States
The Burkhart Research Institute for Orthopaedics
🇺🇸
San Antonio, Texas, United States
Sprintz Center for Pain
🇺🇸
Shenandoah, Texas, United States
Precision Spine Care
🇺🇸
Tyler, Texas, United States