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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| type 2 diabetics with neuropathy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inpatient integrative treatment | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathy-related Quality of Life (QOL-DN) | Norfolk Quality of Life Questionnaire (Vinik et al. 2008) | at T2 |
| Neuropathy-related Quality of Life (QOL-DN) | Norfolk Quality of Life Questionnaire (Vinik et al. 2008) | at T3 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Sensory Testing (QST) |
|
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Inclusion Criteria:
Exclusion Criteria:
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primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Gustav J. Dobos, Prof. MD | University of Duisburg-Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kliniken Essen-Mitte | Essen | North Rhine-Westphalia | 45276 | Germany |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| at T2 and T3 |
| Pain intensity (VAS) | 100mm Visual Analogue Scale | at T2 and T3 |
| Control Beliefs (MHLC / short form) | Short form of the Multidimensional Helath Locus of Control Scale (Hasenbring 1988) | at T2 and T3 |
| Interpretation of Illness (IIQ) | Interpretation of Illness Questionnaire (Büssing et al. 2009) | at T2 and T3 |
| Coping Style (AKU) | Short form of the Adaptive Coping with Disease Questionnaire (Büssing et al. 2010) | at T2 and T3 |
| Anxiety and Depression (HADS) | Hospital Anxiety and Depression Scale (Herrmann et al. 1995) | at T2 and T3 |
| Life Satisfaction (SWLS) | Satisfaction with Life Scale (Diener et al. 1995) | at T2 and T3 |
| Blood sugar Level (HbA1c) | at T2 and T3 |
| Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI) | at T2 and T3 |
| D004700 | Endocrine System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |