None listed
Conditions
Interventions
After a baseline period patients will be randomized to either the best medical practice with adjunctive SCS therapy arm or the best emdical practice without adjunctive SCS therapy arm. The control gro
Sponsors
none
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Age < 18 years; 2. Psychological problems; 3. Neuropathic pain in upper extremities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS score. Measured at baseline and 1, 3, 6, 9 and 12 months after inclusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response rates (greater than or equal to 50% reduction in pain intensity) at all visits; 2. Percent of patients that are pain free (>75% reduction in pain intensity) at all visits; 3. Mean and median percent change in pain intensity at all visits; 4. Pain free time during day and night. 5. McGill Pain Questionnaire; 6. Short Form 36; 7. Changes in pain medication; 8. Compliance rates. 9. Emergent adverse events; 10. Device complications; 11. Premature study withdrawal. Measured at baseline and 1, 3, 6, 9 and 12 months after inclusion. | — |
Contacts
Public ContactC.C. Vos, de
Medisch Spectrum Twente, Department of Neurosurgery, P.O. Box 50000
Outcome results
None listed