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.
Study Type
OBSERVATIONAL
Enrollment
6
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
Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, Germany
Neuropathy-related Quality of Life (QOL-DN)
Norfolk Quality of Life Questionnaire (Vinik et al. 2008)
Time frame: at T2
Neuropathy-related Quality of Life (QOL-DN)
Norfolk Quality of Life Questionnaire (Vinik et al. 2008)
Time frame: at T3
Quantitative Sensory Testing (QST)
* 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)
Time frame: at T2 and T3
Pain intensity (VAS)
100mm Visual Analogue Scale
Time frame: at T2 and T3
Control Beliefs (MHLC / short form)
Short form of the Multidimensional Helath Locus of Control Scale (Hasenbring 1988)
Time frame: at T2 and T3
Interpretation of Illness (IIQ)
Interpretation of Illness Questionnaire (Büssing et al. 2009)
Time frame: at T2 and T3
Coping Style (AKU)
Short form of the Adaptive Coping with Disease Questionnaire (Büssing et al. 2010)
Time frame: at T2 and T3
Anxiety and Depression (HADS)
Hospital Anxiety and Depression Scale (Herrmann et al. 1995)
Time frame: at T2 and T3
Life Satisfaction (SWLS)
Satisfaction with Life Scale (Diener et al. 1995)
Time frame: at T2 and T3
Blood sugar Level (HbA1c)
Time frame: at T2 and T3
Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI)
Time frame: at T2 and T3
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