This is a prospective, longitudinal, single-center, non-randomized, open-label, post-market clinical feasibility study to assess the efficacy of neuromodulation therapies (SCS and DRG) for chronic pain patients with diabetes and investigate whether physical and physiological data collected from diabetic and pre-diabetic chronic pain patients is predictive of subjective patient-reported outcomes (PROs) and of adjustments in patient care. These assessments will be made prior to, during, and after the trial of the SCS or DRG system. The study will be carried out in the United States at a single site.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Standard SCS or DRG therapy
Rush University Medical Center
Chicago, Illinois, United States
RECRUITINGThe mean change in pain scores measured by the Numerical Rating Scale (NRS) at baseline and follow up at 3 months
Change in pain scores measured by the NRS at baseline and follow up study visits at 3 months.
Time frame: At 3 month
The mean change in pain scores measured by the Numerical Rating Scale (NRS) at baseline and follow up at 6 months
Change in pain scores measured by the NRS at baseline and follow up study visits at 6 months.
Time frame: At 6 month
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