NCT00487981

Spinal Cord Stimulation for Painful Diabetic Neuropathy

Precision Spinal Cord Stimulation for Painful Diabetic Neuropathy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetic Neuropathy
• Pain
• Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	Precision Spinal Cord Stimulation	Stimulation on throughout the study once device is implanted

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2007-06-19
• Last updated: 2012-03-13
• Results posted: 2012-03-13

Locations

1 site across 1 country: United States