Clinical trial NCT01296308: Complementary and Integrative Therapy for Diabetic Neuropathy
Official title: Effectiveness of a Complementary and Integrative Therapy in Diabetic Neuropathy Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Diabetic Neuropathy
Keywords: Diabetes Mellitus, Type 2
Diabetic Neuropathy
Complementary Medicine
Alternative Medicine
Integrative Medicine
Quality of Life
Quantitative Sensory Testing
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2011-02-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

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.


Eligibility criteria: 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

Primary outcomes:
measure: Neuropathy-related Quality of Life (QOL-DN)
timeFrame: at T2
measure: Neuropathy-related Quality of Life (QOL-DN)
timeFrame: at T3
Secondary outcomes:
measure: Quantitative Sensory Testing (QST)
timeFrame: at T2 and T3
measure: Pain intensity (VAS)
timeFrame: at T2 and T3
measure: Control Beliefs (MHLC / short form)
timeFrame: at T2 and T3
measure: Interpretation of Illness (IIQ)
timeFrame: at T2 and T3
measure: Coping Style (AKU)
timeFrame: at T2 and T3
measure: Anxiety and Depression (HADS)
timeFrame: at T2 and T3
measure: Life Satisfaction (SWLS)
timeFrame: at T2 and T3
measure: Blood sugar Level (HbA1c)
timeFrame: at T2 and T3
measure: Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI)
timeFrame: at T2 and T3
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
state: NRW
Study officials:
affiliation: University of Duisburg-Essen
name: Gustav J. Dobos, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: