To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.
To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.
Center for Pain and Supportive Care
Phoenix, Arizona, United States
UCSD Medical Center - Jacobs Medical Center
La Jolla, California, United States
Overall Pain Responder Rate
Percentage of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization with no increase in opioid medications
Time frame: 3 months post-randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Denver Back Pain Specialists
Greenwood Village, Colorado, United States
South Lake Pain Institute, Inc
Clermont, Florida, United States
Willis-Knighton River Cities Clinical Research Center
Shreveport, Louisiana, United States
Michigan Pain Consultants
Grand Rapids, Michigan, United States
Forest Health Medical Center
Ypsilanti, Michigan, United States
KC Pain Centers
Lee's Summit, Missouri, United States
Carolinas Research Institute, LLC
Huntersville, North Carolina, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, United States
...and 5 more locations