Spinal cord stimulation for treating diabetic neuropathic pain; a validation study

Completed

Conditions: chronic pain due to diabetes mellitus
painful diabetic neuropathy
10034606

Registration Number: NL-OMON45247

Lead Sponsor: Medisch Spectrum Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

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.
- The pain-sensation on a visual analogue scale is 5 or more.

Exclusion Criteria

- Age < 18 years.
- Psychological problems that requires treatment.
- Addiction (i.e. compulsory) to: drugs, alcohol, medication.
- Insufficient cooperation by patient (motivation, insight or communication).
- Coagulation irregularities/ Anti-coagulants.
- Immune compromised.
- Life expectancy less than 1 year.
- Pregnancy.
- Local infection at the site of the incision
- Implanted pacemaker, ICD or other neuromodulation system

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure is the change in neuropathic pain as measured by VAS<br /><br>score after 6 months of SCS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are an evaluation of the efficacy of SCS treatment in<br /><br>patients with diabetic neuropathic pain as measured by change in pain intensity<br /><br>at all visits, and an evaluation of following health outcome measures: McGill<br /><br>Pain Questionnaire, EuroQoL 5D, HADS, PVAQ, changes in pain medication,<br /><br>patient*s satisfaction and stimulation preference.</p><br>