Complementary and Integrative Therapy for Diabetic Neuropathy

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of a Complementary and Integrative Therapy in Diabetic Neuropathy Patients.

Conditions
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Diabetes Mellitus, Type 2, Diabetic Neuropathy

Intervention / Treatment
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* Other: inpatient integrative treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| type 2 diabetics with neuropathy<br> | Other: inpatient integrative treatment<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, Diabetic Neuropathy, Complementary Medicine, Alternative Medicine, Integrative Medicine, Quality of Life, Quantitative Sensory Testing