Clinical trial NCT00487981: Spinal Cord Stimulation for Painful Diabetic Neuropathy
Official title: Precision Spinal Cord Stimulation for Painful Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetic Neuropathy
Pain
Peripheral Neuropathy
Keywords: Pain
Implantable stimulation device
Neuropathy
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2007-06-19
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Rating at 6 Months Post Activation Compared to Baseline
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Deaconess Pain Management Center
state: Indiana
Study officials:
affiliation: Deaconess Hospital
name: Francis McDonnell, MD
role: PRINCIPAL_INVESTIGATOR
References: