The purpose of this study is to evaluate the effect of different spinal cord stimulation settings in the treatment of leg pain. Subjects will receive a randomized order of four different programmed stimulation settings for 3 weeks each followed by a fifth and final setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
RestoreSensor or RestoreUltra Setting 1
Medtronic RestoreSensor or RestoreUltra Setting 2
Medtronic RestoreSensor or RestoreUltra Setting 3
Numeric Pain Rating Scale - Leg pain
Time frame: 12 weeks
Brief Pain Inventory - Pain severity
Time frame: 12 weeks
Brief Pain Inventory - Pain interference
Time frame: 12 weeks
Quantitative Sensory Testing - Vibration threshold
Time frame: 12 weeks
Quantitative Sensory Testing - Electrical stimuli tolerance
Time frame: 12 weeks
Numeric Pain Rating Scale - Back pain
Time frame: 12 weeks
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Medtronic RestoreSensor or RestoreUltra Setting 4