Spinal Cord Stimulation for Painful Diabetic Neuropathy
Stopped early · Phase 4
Conditions studied: Diabetic Neuropathy, Pain, Peripheral Neuropathy
In brief
The purpose of this study is to evaluate Spinal Cord Stimulation (SCS) therapy in individuals who suffer from painful diabetic peripheral neuropathy. Patients invited to participate in this study will be eligible for SCS therapy, and will have already selected therapy with the Advanced Bionics Precision system independent of possible inclusion in this study. The device, accessories, and procedures associated with device placement and the indications for use are all consistent with the current and approved product labeling.
Key facts
- Study ID
- NCT00487981
- Run by
- Boston Scientific Corporation
- People needed
- 1
- Starts
- 2007-02-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2012-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have chronic neuropathic pain in at least one limb with a score of at least 3 using the Michigan Neuropathy Screening Instrument (MNSI) secondary to Type 1 or Type 2 diabetes
- Have chronic neuropathic pain for at least 12 months
- Be 18 years of age or older
- Be refractory to pain medication including gabapentin or the use of pain medication is contraindicated or not tolerated because of side effects or other medical condition
- Be an appropriate candidate for SCS therapy and have already decided to use the Precision system
- Be willing and able to comply with all study related procedures and visits
- Be capable of reading and understanding patient information materials and giving written informed consent
You may not qualify if…
- Are a smoker
- Have any other chronic pain condition likely to confound evaluation of study endpoints
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints such as peripheral vascular disease or neurological disorders unrelated to diabetic neuropathy
Where it is running
- Deaconess Pain Management Center — Evansville, Indiana, United States
Full record on ClinicalTrials.gov
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