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Spinal Cord Stimulation for Painful Diabetic Neuropathy (DPN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00487981
Recruitment Status : Terminated (Insufficient Data Collected)
First Posted : June 19, 2007
Results First Posted : March 13, 2012
Last Update Posted : March 13, 2012
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Pain Peripheral Neuropathy Device: Precision Spinal Cord Stimulation Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Precision Spinal Cord Stimulation for Painful Diabetic Neuropathy
Study Start Date : February 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Spinal Cord Stimulation Group
Spinal Cord Stimulation (SCS) Treatment Group
Device: Precision Spinal Cord Stimulation
Stimulation on throughout the study once device is implanted
Other Name: Precision Spinal Cord Stimulation System

Primary Outcome Measures :
  1. Pain Rating at 6 Months Post Activation Compared to Baseline [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00487981

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United States, Indiana
Deaconess Pain Management Center
Evansville, Indiana, United States, 47747
Sponsors and Collaborators
Boston Scientific Corporation
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Principal Investigator: Francis McDonnell, MD Deaconess Hospital
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Responsible Party: Boston Scientific Corporation Identifier: NCT00487981    
Other Study ID Numbers: SCS0206
First Posted: June 19, 2007    Key Record Dates
Results First Posted: March 13, 2012
Last Update Posted: March 13, 2012
Last Verified: February 2012
Keywords provided by Boston Scientific Corporation:
Implantable stimulation device
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases