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 pain.(SCS 001)
Recruiting
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 45
Inclusion Criteria
1. Chronic, diabetic, peripheral neuropathic pain that exists for more than one year;
2. Patient cannot be treated further otherwise according to patients’ medical specialist;
3. The pain-sensation on a VAS-scale is minimal 5 (recording both for day and night time).
Exclusion Criteria
1. Age < 18 years;
2. Psychological problems;
3. Neuropathic pain in upper extremities.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS score.<br>Measured at baseline and 1, 3, 6,<br>9 and 12 months after inclusion.
- Secondary Outcome Measures
Name Time Method 1. Response rates (greater than or equal to 50% reduction in pain intensity) at all visits;<br>2. Percent of patients that are pain free (>75% reduction in pain intensity) at all visits;<br>3. Mean and median percent change in pain intensity at all visits;<br>4. Pain free time during day and night.<br>5. McGill Pain Questionnaire;<br>6. Short Form 36;<br>7. Changes in pain medication;<br>8. Compliance rates.<br>9. Emergent adverse events;<br>10. Device complications;<br>11. Premature study withdrawal.<br>Measured at baseline and 1, 3, 6,<br>9 and 12 months after inclusion.