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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heidemarie Haller, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01296308
First received: February 14, 2011
Last updated: July 16, 2012
Last verified: July 2012

February 14, 2011
July 16, 2012
March 2011
July 2012   (final data collection date for primary outcome measure)
  • Neuropathy-related Quality of Life (QOL-DN) [ Time Frame: at T2 ] [ Designated as safety issue: No ]
    Norfolk Quality of Life Questionnaire (Vinik et al. 2008)
  • Neuropathy-related Quality of Life (QOL-DN) [ Time Frame: at T3 ] [ Designated as safety issue: No ]
    Norfolk Quality of Life Questionnaire (Vinik et al. 2008)
Same as current
Complete list of historical versions of study NCT01296308 on ClinicalTrials.gov Archive Site
  • Quantitative Sensory Testing (QST) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    100mm Visual Analogue Scale
  • Control Beliefs (MHLC / short form) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    Short form of the Multidimensional Helath Locus of Control Scale (Hasenbring 1988)
  • Interpretation of Illness (IIQ) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    Interpretation of Illness Questionnaire (Büssing et al. 2009)
  • Coping Style (AKU) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    Short form of the Adaptive Coping with Disease Questionnaire (Büssing et al. 2010)
  • Anxiety and Depression (HADS) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale (Herrmann et al. 1995)
  • Life Satisfaction (SWLS) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    Satisfaction with Life Scale (Diener et al. 1995)
  • Blood sugar Level (HbA1c) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  • Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  • Quantitative Sensory Testing (QST) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    100mm Visual Analogue Scale
  • Control Beliefs (MHLC / short form) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    Short form of the Multidimensional Helath Locus of Control Scale (Hasenbring 1988)
  • Interpretation of Illness (IIQ) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    Interpretation of Illness Questionnaire (Büssing et al. 2009)
  • Coping Style (AKU) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    Short form of the Adaptive Coping with Disease Questionnaire (Büssing et al. 2010)
  • Anxiety and Depression (HADS) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale (Herrmann et al. 1995)
  • Life Satisfaction (SWLS) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
    Satisfaction with Life Scale (Diener et al. 1995)
  • Blood sugar Level (HbA1c) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  • Ankle Brachial Index (ABI) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
  • Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI) [ Time Frame: at T2 and T3 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Complementary and Integrative Therapy for Diabetic Neuropathy
Effectiveness of a Complementary and Integrative Therapy in Diabetic Neuropathy Patients.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

primary care clinic

  • Diabetes Mellitus, Type 2
  • Diabetic 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
type 2 diabetics with neuropathy
Intervention: Other: inpatient integrative treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01296308
10-4517
Yes
Heidemarie Haller, Universität Duisburg-Essen
Universität Duisburg-Essen
Not Provided
Principal Investigator: Gustav J. Dobos, Prof. MD University of Duisburg-Essen
Universität Duisburg-Essen
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP