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Completed

NCT Number: NCT01296308

Complementary and Integrative Therapy for Diabetic Neuropathy

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Neuropathy-related Quality of Life (QOL-DN)

    Time frame: at T2

    Norfolk Quality of Life Questionnaire (Vinik et al. 2008)

  2. Neuropathy-related Quality of Life (QOL-DN)

    Time frame: at T3

    Norfolk Quality of Life Questionnaire (Vinik et al. 2008)

Secondary outcomes

  1. 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)
  2. Pain intensity (VAS)

    Time frame: at T2 and T3

    100mm Visual Analogue Scale

  3. Control Beliefs (MHLC / short form)

    Time frame: at T2 and T3

    Short form of the Multidimensional Helath Locus of Control Scale (Hasenbring 1988)

  4. Interpretation of Illness (IIQ)

    Time frame: at T2 and T3

    Interpretation of Illness Questionnaire (Büssing et al. 2009)

  5. Coping Style (AKU)

    Time frame: at T2 and T3

    Short form of the Adaptive Coping with Disease Questionnaire (Büssing et al. 2010)

  6. Anxiety and Depression (HADS)

    Time frame: at T2 and T3

    Hospital Anxiety and Depression Scale (Herrmann et al. 1995)

  7. Life Satisfaction (SWLS)

    Time frame: at T2 and T3

    Satisfaction with Life Scale (Diener et al. 1995)

  8. Blood sugar Level (HbA1c)

    Time frame: at T2 and T3

  9. Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI)

    Time frame: at T2 and T3

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

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

Acronym: CIT-DN

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 15, 2011
Registry last updated
Jul 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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