Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, 45276, Germany
NCT Number: NCT01296308
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.
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Notify Me18 year and older
All sexes
Observational
Essen, North Rhine-Westphalia, 45276, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: at T2
Norfolk Quality of Life Questionnaire (Vinik et al. 2008)
Time frame: at T3
Norfolk Quality of Life Questionnaire (Vinik et al. 2008)
Time frame: at T2 and T3
Time frame: at T2 and T3
100mm Visual Analogue Scale
Time frame: at T2 and T3
Short form of the Multidimensional Helath Locus of Control Scale (Hasenbring 1988)
Time frame: at T2 and T3
Interpretation of Illness Questionnaire (Büssing et al. 2009)
Time frame: at T2 and T3
Short form of the Adaptive Coping with Disease Questionnaire (Büssing et al. 2010)
Time frame: at T2 and T3
Hospital Anxiety and Depression Scale (Herrmann et al. 1995)
Time frame: at T2 and T3
Satisfaction with Life Scale (Diener et al. 1995)
Time frame: at T2 and T3
Time frame: at T2 and T3
Universität Duisburg-Essen
Other
Effectiveness of a Complementary and Integrative Therapy in Diabetic Neuropathy Patients.
Acronym: CIT-DN
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