Onderzoek naar ruggenmergstimulatie voor de behandeling van diabetische neuropathische pijn, een evaluatie studie
Recruiting
- Conditions
- diabetes mellitus, <br />diabetic neuropathic pain, <br />spinal cord stimulation,<br />diabetische neuropathische pijn,<br />ruggenmergstimulatie
- Registration Number
- NL-OMON29505
- Lead Sponsor
- Medisch Spectrum Twente,<br>Enschede, the Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
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.
Exclusion Criteria
- Age < 18 years.
- Psychological problems that requires treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measure is the change in neuropathic pain as measured by visual analogue scale (VAS) score after 6 months of SCS.
- Secondary Outcome Measures
Name Time Method - evaluation of patient preference of stimulation settings, <br /><br>- satisfaction with SCS treatment (PGIC),<br /><br>- evaluation of the efficacy of SCS treatment in patients with diabetic neuropathic pain as measured by mean and median percent change in pain intensity at all visits, <br>