The aims of the study are to compare automatic control of spinal cord stimulation with manual control in patients with chronic pain of the trunk and limbs
Subjects will use the Saluda Medical External Trial System to compare automatic control of spinal cord stimulation with manual control in a randomized, blinded, crossover study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
69
The Pain Center of Arizona
Phoenix, Arizona, United States
Arizona Pain Specialists
Scottsdale, Arizona, United States
Center for Neurosciences
Tucson, Arizona, United States
Percentage of Subjects With Improved Pain Relief and/or Stimulation Side Effects During the Automatic Control Arm Relative to the Manual Control Arm
After subjects experience both automatic and manual control after 20 days, subjects are asked to compare pain relief and stimulation side effects between the two arms of the study (blinded) in two separate domains using two 5-point Likert scales. The outcome measure for the primary objective is the percentage of subjects who report improved pain relief with no worsening of stimulation side-effects or improved stimulation side-effects with no loss of pain relief during the automatic control arm relative to the manual control arm. These subjects were considered successful for the primary outcome.
Time frame: 20 days
Number of Adverse Events as a Measure of Safety
Time frame: 20 days
Compare change from baseline of pain scores between automatic and manual control stimulation
Pain scores are obtained from the Visual Analog Scale (VAS) administered at baseline and after each arm of the study
Time frame: 20 days
Compare change from baseline of quality of life scores, between automatic and manual control stimulation
Quality of life scores are obtained from the Short Form - 36 (SF-36), and EuroQol-5D-5L questionnaires administered at baseline and after each arm of the study
Time frame: 20 days
Compare patient satisfaction with stimulation as measured on a 5-point Likert scale between automatic and manual control stimulation
Time frame: 20 days
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