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

This study has been completed.
Information provided by (Responsible Party):
Heidemarie Haller, Universität Duisburg-Essen Identifier:
First received: February 14, 2011
Last updated: July 16, 2012
Last verified: July 2012
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.

Condition Intervention
Diabetes Mellitus, Type 2 Diabetic Neuropathy Other: inpatient integrative treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of a Complementary and Integrative Therapy in Diabetic Neuropathy Patients.

Resource links provided by NLM:

Further study details as provided by Heidemarie Haller, Universität Duisburg-Essen:

Primary Outcome Measures:
  • Neuropathy-related Quality of Life (QOL-DN) [ Time Frame: at T2 ]
    Norfolk Quality of Life Questionnaire (Vinik et al. 2008)

  • Neuropathy-related Quality of Life (QOL-DN) [ Time Frame: at T3 ]
    Norfolk Quality of Life Questionnaire (Vinik et al. 2008)

Secondary Outcome Measures:
  • Quantitative Sensory Testing (QST) [ Time Frame: at T2 and T3 ]
    • 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 ]
    100mm Visual Analogue Scale

  • Control Beliefs (MHLC / short form) [ Time Frame: at T2 and T3 ]
    Short form of the Multidimensional Helath Locus of Control Scale (Hasenbring 1988)

  • Interpretation of Illness (IIQ) [ Time Frame: at T2 and T3 ]
    Interpretation of Illness Questionnaire (Büssing et al. 2009)

  • Coping Style (AKU) [ Time Frame: at T2 and T3 ]
    Short form of the Adaptive Coping with Disease Questionnaire (Büssing et al. 2010)

  • Anxiety and Depression (HADS) [ Time Frame: at T2 and T3 ]
    Hospital Anxiety and Depression Scale (Herrmann et al. 1995)

  • Life Satisfaction (SWLS) [ Time Frame: at T2 and T3 ]
    Satisfaction with Life Scale (Diener et al. 1995)

  • Blood sugar Level (HbA1c) [ Time Frame: at T2 and T3 ]
  • Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI) [ Time Frame: at T2 and T3 ]

Enrollment: 6
Study Start Date: March 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
type 2 diabetics with neuropathy Other: inpatient integrative treatment
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01296308

Kliniken Essen-Mitte
Essen, NRW, Germany, 45276
Sponsors and Collaborators
Universität Duisburg-Essen
Principal Investigator: Gustav J. Dobos, Prof. MD University of Duisburg-Essen
  More Information

Responsible Party: Heidemarie Haller, MSc, Universität Duisburg-Essen Identifier: NCT01296308     History of Changes
Other Study ID Numbers: 10-4517
Study First Received: February 14, 2011
Last Updated: July 16, 2012

Keywords provided by Heidemarie Haller, Universität Duisburg-Essen:
Diabetes Mellitus, Type 2
Diabetic Neuropathy
Complementary Medicine
Alternative Medicine
Integrative Medicine
Quality of Life
Quantitative Sensory Testing

Additional relevant MeSH terms:
Diabetes Mellitus
Peripheral Nervous System Diseases
Diabetes Mellitus, Type 2
Diabetic Neuropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications processed this record on September 18, 2017