Diabetes Mellitus, Type 2, Diabetic Neuropathy
Conditions
Keywords
Diabetes Mellitus, Type 2, Diabetic Neuropathy, Complementary Medicine, Alternative Medicine, Integrative Medicine, Quality of Life, Quantitative Sensory Testing
Brief summary
Despite the long tradition of complementary and alternative medicine (CAM) therapies there are hardly any interventional trials on type 2 diabetes mellitus. Hence this pilot study aims to investigate the influence of a two weeks integrative inpatient therapy on the quality of life in 50 patients suffering from diabetic neuropathy. Integrative treatment includes aspects of conventional and traditional European and Chinese medicine, mind-body medicine, physical therapy and lifestyle modification (nutrition advices, stress management and exercise training). The observational design intends four measurement points: tree months before (T0), directly before (T1), directly after treatment (T2) and three months follow-up (T3). The subjective evaluation of the neuropathy-related quality of life was combined with neurophysiologic instruments (QST), to measure neuropathic symptoms. Also pain intensity, locus of control, interpretation of illness, coping style, anxiety/depression, life satisfaction and several biomarkers (HbA1c, ABI, WHR and BMI) are measured. In addition a qualitative interview should give a view to patient perspective of therapy process.
Interventions
OTHERinpatient integrative treatment
two weeks inpatient integrative therapy: conventional medicine, traditional European and Chinese medicine (TCM), mind-body medicine, physical therapy, lifestyle modification program: nutrition advices, stress management, exercise training
Sponsors
Universität Duisburg-Essen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* over 18 years old * diabetes mellitus type 2
Exclusion criteria
* diabetes mellitus type 1 * pregnancy * oncologic diseases * systemic neurological diseases * other induced neuropathy (radicular, s/p alcohol abuse, chemotherapy-induced) * other severe psychiatric or somatic comorbidity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathy-related Quality of Life (QOL-DN) | at T2 | Norfolk Quality of Life Questionnaire (Vinik et al. 2008) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity (VAS) | at T2 and T3 | 100mm Visual Analogue Scale |
| Control Beliefs (MHLC / short form) | at T2 and T3 | Short form of the Multidimensional Helath Locus of Control Scale (Hasenbring 1988) |
| Interpretation of Illness (IIQ) | at T2 and T3 | Interpretation of Illness Questionnaire (Büssing et al. 2009) |
| Coping Style (AKU) | at T2 and T3 | Short form of the Adaptive Coping with Disease Questionnaire (Büssing et al. 2010) |
| Quantitative Sensory Testing (QST) | at T2 and T3 | * Thermal detection thresholds (CDT, WDT), thermal pain thresholds (CPT, HPT) and paradoxical heat sensations (PHS) * Mechanical detection threshold (MDT), mechanical pain threshold (MPT), mechanical pain sensitivity (MPS), dynamic mechanical allodynia (ALL) and wind-up ratio (WUR) * Vibration detection threshold (VDT) * Pressure pain threshold (PPT) (Rolke et al. 2006) |
| Life Satisfaction (SWLS) | at T2 and T3 | Satisfaction with Life Scale (Diener et al. 1995) |
| Blood sugar Level (HbA1c) | at T2 and T3 | — |
| Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI) | at T2 and T3 | — |
| Anxiety and Depression (HADS) | at T2 and T3 | Hospital Anxiety and Depression Scale (Herrmann et al. 1995) |
Countries
Germany
Outcome results
None listed