The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
134
Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
Hope Research Institute
Phoenix, Arizona, United States
Arizona Pain Specialists
Scottsdale, Arizona, United States
Number of Participants With Composite Endpoint Success
The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Time frame: 3 months
Percent Change From Baseline in Leg Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Time frame: 3 months
Percent Change From Baseline in Back Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Time frame: 3 months
Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Time frame: 3 months
Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Time frame: 3 months
Number of Participants With Composite Endpoint Success
The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Summit Pain Alliance
Santa Rosa, California, United States
Thrive Clinic
Santa Rosa, California, United States
IPM Medical Group
Walnut Creek, California, United States
Pain Management Associates
Lee's Summit, Missouri, United States
Premier Pain Centers
Shrewsbury, New Jersey, United States
Ainsworth Institute of Pain Management
New York, New York, United States
Center for Clinical Research
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
...and 6 more locations
Time frame: 12 months
Percent Change From Baseline in Leg Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Time frame: 12 months
Percent Change From Baseline in Back Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Time frame: 12 months
Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Time frame: 12 months
Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Time frame: 12 months