Transcutaneous spinal direct current stimulation in symptomatic management of patients with diabetic polyneuropathy
- Conditions
- G63.2Diabetic polyneuropathy
- Registration Number
- DRKS00013525
- Lead Sponsor
- Klinik für Anästhesiologie, Intensiv-, Palliativ- und Schmerzmedizin; Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Bochum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 50
Voluntariness; age >18 years at time of examination; proficient german language skils; ability to fully understand the type and purpose of this study; ability to cooperate with the research-team and fulfill all requirements of the study; diabetes mellitus with diabetic polyneuropathy and: 1. pain in the lower extremity or paresthesia in the lower extremity and 2. HbA1c <8,5% (recorded in the last six weeks); informed consent (written).
Withdrawal of the informed consent; psychiatric disease; neurological comorbidity; change in medication in the preceding six weeks (e.g. antidiabetics, antidepressants, analgetics or other centrally active substances); employees of the principal investigator who is conducting and/or participating in this or in other studies; needle EMG: wound healing disorders, diabetic foot syndrome; cardiac pacemaker; secondary exclusion criteria: change in medication between the two examinations.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intensity of pain in patients affected by dPN, measured by Numeric Rating Scale (NRS 0-10), during the control-examination directly after stimulation, 30 min and 24h later.
- Secondary Outcome Measures
Name Time Method Degree of paresthesia in patients (Score 0-10 with the paresthesia questionaire, quality of sleep (equal, better, worse) and sensibility with the NDS-Score and a clinical examination are examined directly, 30min and 24h after stimulation.<br>