Spinal Cord Stimulation for Painful Diabetic Neuropathy (DPN)

This study has been terminated.
(Insufficient Data Collected)
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00487981
First received: June 15, 2007
Last updated: February 21, 2012
Last verified: February 2012

June 15, 2007
February 21, 2012
February 2007
September 2008   (final data collection date for primary outcome measure)
Pain Rating at 6 Months Post Activation Compared to Baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The primary efficacy endpoint is pain rating at 6 months post-activation as compared to baseline
Complete list of historical versions of study NCT00487981 on ClinicalTrials.gov Archive Site
Not Provided
  • Pain severity at 9 and 12 months post-activation as compared to baseline
  • Quality of Life
  • Quality of Sleep
  • Depression
  • Days lost from work, work productivity loss, and total disability loss
  • Degree of extremity neuropathy
  • Peripheral sensory perception
  • Peripheral circulation
  • Ulcer size if present
Not Provided
Not Provided
 
Spinal Cord Stimulation for Painful Diabetic Neuropathy
Precision Spinal Cord Stimulation for Painful Diabetic Neuropathy

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetic Neuropathy
  • Pain
  • Peripheral Neuropathy
Device: Precision Spinal Cord Stimulation
Stimulation on throughout the study once device is implanted
Other Name: Precision Spinal Cord Stimulation System
Spinal Cord Stimulation Group
Spinal Cord Stimulation (SCS) Treatment Group
Intervention: Device: Precision Spinal Cord Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00487981
SCS0206
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Francis McDonnell, MD Deaconess Hospital
Boston Scientific Corporation
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP