Complementary and Integrative Therapy for Diabetic Neuropathy (CIT-DN)

• Neuropathy-related Quality of Life (QOL-DN) [ Time Frame: at T2 ] [ Designated as safety issue: No ]
  Norfolk Quality of Life Questionnaire (Vinik et al. 2008)
• Neuropathy-related Quality of Life (QOL-DN) [ Time Frame: at T3 ] [ Designated as safety issue: No ]
  Norfolk Quality of Life Questionnaire (Vinik et al. 2008)

• Quantitative Sensory Testing (QST) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  • 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)
• Pain intensity (VAS) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  100mm Visual Analogue Scale
• Control Beliefs (MHLC / short form) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  Short form of the Multidimensional Helath Locus of Control Scale (Hasenbring 1988)
• Interpretation of Illness (IIQ) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  Interpretation of Illness Questionnaire (Büssing et al. 2009)
• Coping Style (AKU) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  Short form of the Adaptive Coping with Disease Questionnaire (Büssing et al. 2010)
• Anxiety and Depression (HADS) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  Hospital Anxiety and Depression Scale (Herrmann et al. 1995)
• Life Satisfaction (SWLS) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  Satisfaction with Life Scale (Diener et al. 1995)
• Blood sugar Level (HbA1c) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
• Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]

• Quantitative Sensory Testing (QST) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  • 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)
• Pain intensity (VAS) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  100mm Visual Analogue Scale
• Control Beliefs (MHLC / short form) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  Short form of the Multidimensional Helath Locus of Control Scale (Hasenbring 1988)
• Interpretation of Illness (IIQ) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  Interpretation of Illness Questionnaire (Büssing et al. 2009)
• Coping Style (AKU) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  Short form of the Adaptive Coping with Disease Questionnaire (Büssing et al. 2010)
• Anxiety and Depression (HADS) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  Hospital Anxiety and Depression Scale (Herrmann et al. 1995)
• Life Satisfaction (SWLS) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  Satisfaction with Life Scale (Diener et al. 1995)
• Blood sugar Level (HbA1c) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
• Ankle Brachial Index (ABI) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
• Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]

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.

primary care clinic

• Diabetes Mellitus, Type 2
• Diabetic Neuropathy

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