Effectiveness of a Complementary and Integrative Therapy in Diabetic Neuropathy Patients.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Universität Duisburg-Essen
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Neuropathy-related Quality of Life (QOL-DN)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Heidemarie Haller
MSc
Universität Duisburg-Essen
Eligibility Criteria
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
Outcomes
Primary Outcomes
Neuropathy-related Quality of Life (QOL-DN)
Time Frame: at T3
Norfolk Quality of Life Questionnaire (Vinik et al. 2008)
Secondary Outcomes
- Quantitative Sensory Testing (QST)(at T2 and T3)
- Pain intensity (VAS)(at T2 and T3)
- Control Beliefs (MHLC / short form)(at T2 and T3)
- Interpretation of Illness (IIQ)(at T2 and T3)
- Coping Style (AKU)(at T2 and T3)
- Anxiety and Depression (HADS)(at T2 and T3)
- Life Satisfaction (SWLS)(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)