Complementary and Integrative Therapy for Diabetic Neuropathy

Diabetes Mellitus, Type 2 Clinical Trial

— CIT-DN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296308
• Other study ID #: 10-4517
• Status: Completed
• Phase: N/A
• First received: February 14, 2011
• Last updated: July 16, 2012
• Start date: March 2011
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Neuropathies
• Diabetic Neuropathy

Intervention

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

Locations

Country	Name	City	State
Germany	Kliniken Essen-Mitte	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropathy-related Quality of Life (QOL-DN)	Norfolk Quality of Life Questionnaire (Vinik et al. 2008)	at T2	No
Primary	Neuropathy-related Quality of Life (QOL-DN)	Norfolk Quality of Life Questionnaire (Vinik et al. 2008)	at T3	No
Secondary	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	No
Secondary	Pain intensity (VAS)	100mm Visual Analogue Scale	at T2 and T3	No
Secondary	Control Beliefs (MHLC / short form)	Short form of the Multidimensional Helath Locus of Control Scale (Hasenbring 1988)	at T2 and T3	No
Secondary	Interpretation of Illness (IIQ)	Interpretation of Illness Questionnaire (Büssing et al. 2009)	at T2 and T3	No
Secondary	Coping Style (AKU)	Short form of the Adaptive Coping with Disease Questionnaire (Büssing et al. 2010)	at T2 and T3	No
Secondary	Anxiety and Depression (HADS)	Hospital Anxiety and Depression Scale (Herrmann et al. 1995)	at T2 and T3	No
Secondary	Life Satisfaction (SWLS)	Satisfaction with Life Scale (Diener et al. 1995)	at T2 and T3	No
Secondary	Blood sugar Level (HbA1c)		at T2 and T3	No
Secondary	Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI)		at T2 and T3	No