An open prospective randomised long-term effectiveness study, comparing best medical practice with or without adjunctive Spinal Cord Stimulation in patients with chronic diabetic neuropathic pai
Not Applicable
Completed
- Conditions
- Diabetic neuropathic painNutritional, Metabolic, EndocrineDiabetes mellitus
- Registration Number
- ISRCTN03269533
- Lead Sponsor
- Medisch Spectrum Twente (The Netherlands)
- Brief Summary
2009 results in https://pubmed.ncbi.nlm.nih.gov/18413161/ (added 14/01/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
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 five (recording both for day and night time)
Exclusion Criteria
1. Aged less than 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: measured at baseline and one, three, six, nine and 12 months after inclusion.
- Secondary Outcome Measures
Name Time Method <br> 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 (more than 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><br> Measured at baseline and one, three, six, nine and 12 months after inclusion.<br>