Spinal Cord Stimulation for Painful Diabetic Neuropathy

Pain Clinical Trial

— DPN  

Official title:

Precision Spinal Cord Stimulation for Painful Diabetic Neuropathy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00487981
• Other study ID #: SCS0206
• Status: Terminated
• Phase: Phase 4
• First received: June 15, 2007
• Last updated: February 21, 2012
• Start date: February 2007
• Est. completion date: September 2008

Study information

• Verified date: February 2012
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy
• Pain
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Device:
• Precision Spinal Cord Stimulation
Stimulation on throughout the study once device is implanted

Locations

Country	Name	City	State
United States	Deaconess Pain Management Center	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Rating at 6 Months Post Activation Compared to Baseline		6 months	No