Spinal Cord Stimulation for Painful Diabetic Neuropathy

Phase

Condition

Chronic Pain

Diabetic Neuropathy

Peripheral Neuropathy

Treatment

N/A

Clinical Study ID

NCT00487981

SCS0206

Ages > 18
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Have chronic neuropathic pain in at least one limb with a score of at least 3 usingthe Michigan Neuropathy Screening Instrument (MNSI) secondary to Type 1 or Type 2diabetes
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 iscontraindicated or not tolerated because of side effects or other medical condition
Be an appropriate candidate for SCS therapy and have already decided to use thePrecision system
Be willing and able to comply with all study related procedures and visits
Be capable of reading and understanding patient information materials and givingwritten informed consent

Exclusion

Exclusion Criteria:

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 studyprocedures or likely to confound evaluation of study endpoints such as peripheralvascular disease or neurological disorders unrelated to diabetic neuropathy

Study Design

February 01, 2007

September 30, 2008

Study Description

The management of neuropathic pain is often difficult, and the available treatment options rarely provide complete relief. Although prevention by means of glycemic control is the first priority, up to 20% of patients will develop Diabetic Peripheral Neuropathy (DPN) and require active drug therapy. Select anti-depressants, anti-epileptics, and opioids have generally been the first-line pharmacologic treatments for neuropathic pain. Topical creams have been used to achieve local control. Nonconventional therapies have included acupuncture and magnet therapy. However, all of these treatments have limited utility because of marginal efficacy. Various forms of electric stimulation have been shown to improve the symptoms of DPN. Advances in spinal cord stimulation technology have encouraged broader use of this treatment modality in the management of chronic painful DPN.

Connect with a study center

Deaconess Pain Management Center
Evansville, Indiana 47747
United States
Site Not Available

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