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Spinal Cord Stimulation for Painful Diabetic Neuropathy (DPN)

Primary Purpose

Diabetic Neuropathy, Pain, Peripheral Neuropathy

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Precision Spinal Cord Stimulation
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy focused on measuring Pain, Implantable stimulation device, Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Deaconess Pain Management Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Spinal Cord Stimulation Group

Arm Description

Spinal Cord Stimulation (SCS) Treatment Group

Outcomes

Primary Outcome Measures

Pain Rating at 6 Months Post Activation Compared to Baseline

Secondary Outcome Measures

Full Information

First Posted
June 15, 2007
Last Updated
February 21, 2012
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00487981
Brief Title
Spinal Cord Stimulation for Painful Diabetic Neuropathy
Acronym
DPN
Official Title
Precision Spinal Cord Stimulation for Painful Diabetic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Why Stopped
Insufficient Data Collected
Study Start Date
February 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy, Pain, Peripheral Neuropathy
Keywords
Pain, Implantable stimulation device, Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal Cord Stimulation Group
Arm Type
Other
Arm Description
Spinal Cord Stimulation (SCS) Treatment Group
Intervention Type
Device
Intervention Name(s)
Precision Spinal Cord Stimulation
Other Intervention Name(s)
Precision Spinal Cord Stimulation System
Intervention Description
Stimulation on throughout the study once device is implanted
Primary Outcome Measure Information:
Title
Pain Rating at 6 Months Post Activation Compared to Baseline
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis McDonnell, MD
Organizational Affiliation
Deaconess Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deaconess Pain Management Center
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47747
Country
United States

12. IPD Sharing Statement

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Spinal Cord Stimulation for Painful Diabetic Neuropathy

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