Spinal Cord Stimulation for Painful Diabetic Neuropathy

NCT ID: NCT00487981

Last Updated: 2012-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-09-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Spinal Cord Stimulation Group

Spinal Cord Stimulation (SCS) Treatment Group

Group Type: OTHER

Precision Spinal Cord Stimulation

Intervention Type: DEVICE

Stimulation on throughout the study once device is implanted

Interventions

Precision Spinal Cord Stimulation

Stimulation on throughout the study once device is implanted

Intervention Type: DEVICE

Other Intervention Names

Precision Spinal Cord Stimulation System

Eligibility Criteria

Inclusion Criteria

• 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

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 study procedures or likely to confound evaluation of study endpoints such as peripheral vascular disease or neurological disorders unrelated to diabetic neuropathy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis McDonnell, MD

Role: PRINCIPAL_INVESTIGATOR

Deaconess Hospital

Locations

Deaconess Pain Management Center

Evansville, Indiana, United States

Countries

United States

Other Identifiers

SCS0206

Identifier Type: -

Identifier Source: org_study_id