An open prospective randomized long-term effectiveness study, comparing best medical practice with or without adjunctive spinal cord stimulation in patients with chronic diabetic neuropathic pai
Phase 4
Completed
- Conditions
- chronic neuropatic pain in patients with diabetes1001842410034606
- Registration Number
- NL-OMON38404
- Lead Sponsor
- St. Jude Medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
Inclusion Criteria
chronic, peripheral diabetic neuropathic pain that exists for more than one year
patient cannot be treated further otherwise according to patient's medical specialist
pain sensation on a VAS scale is minimal 5 (recording both for night and day)
Exclusion Criteria
age < 18 years
psychological problems
neuropathic pain in upper extremities
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To demonstrate superiority over time in treatment of pain of best medical<br /><br>practice with adjunctive SCS Therapy compared to best medical practice without<br /><br>SCS Therapy in patients with chronic diabetic neuropathic pain as measured by<br /><br>VAS score.</p><br>
- Secondary Outcome Measures
Name Time Method