chronic pain due to diabetes mellitus painful diabetic neuropathy
Conditions
Interventions
All patients will have a trial stimulation period with an external SCS pulse
generator. If the trial is successful ( > 25% pain reduction) an SCS system
will be implanted.
Sponsors
Medisch Spectrum Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Peripheral neuropathic pain that exists for more than 6 months and is due to diabetes mellitus. - Patient cannot be treated further otherwise according to patients* medical specialist. - The pain-sensation on a visual analogue scale is 5 or more.
Exclusion criteria
Exclusion criteria: - Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure is the change in neuropathic pain as measured by VAS score after 6 months of SCS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are an evaluation of the efficacy of SCS treatment in patients with diabetic neuropathic pain as measured by change in pain intensity at all visits, and an evaluation of following health outcome measures: McGill Pain Questionnaire, EuroQoL 5D, HADS, PVAQ, changes in pain medication, patient*s satisfaction and stimulation preference. | — |
Countries
Netherlands
Outcome results
None listed