Complementary and Integrative Therapy for Diabetic Neuropathy

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetic Neuropathy
• Interventions: Other: inpatient integrative treatment

• Registration Number: NCT01296308
• Lead Sponsor: Universität Duisburg-Essen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-14
• Study First Posted: 2011-02-15
• Study Start: 2011-03
• Status Verified: 2012-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
type 2 diabetics with neuropathy	inpatient integrative treatment	-

Primary Outcome Measures

Name	Time	Method
Neuropathy-related Quality of Life (QOL-DN)	at T3	Norfolk Quality of Life Questionnaire (Vinik et al. 2008)

Secondary Outcome Measures

Name	Time	Method
Quantitative Sensory Testing (QST)	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)	at T2 and T3	100mm Visual Analogue Scale
Control Beliefs (MHLC / short form)	at T2 and T3	Short form of the Multidimensional Helath Locus of Control Scale (Hasenbring 1988)
Interpretation of Illness (IIQ)	at T2 and T3	Interpretation of Illness Questionnaire (Büssing et al. 2009)
Coping Style (AKU)	at T2 and T3	Short form of the Adaptive Coping with Disease Questionnaire (Büssing et al. 2010)
Anxiety and Depression (HADS)	at T2 and T3	Hospital Anxiety and Depression Scale (Herrmann et al. 1995)
Life Satisfaction (SWLS)	at T2 and T3	Satisfaction with Life Scale (Diener et al. 1995)
Blood sugar Level (HbA1c)	at T2 and T3
Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI)	at T2 and T3

Trial Locations

Locations (1)

Kliniken Essen-Mitte; 🇩🇪 Essen, NRW, Germany