Diabetic Neuropathy
Conditions
Keywords
acupuncture, peripheral neuropathy, diabetes mellitus type II, neurophysiology, nerve conduction velocity
Brief summary
Multicentric,randomized, two-armed confirmatory trial on the effectiveness of acupuncture in patients with symptomatic peripheral diabetic neuropathy compared to routine care.
Detailed description
The study will investigate the effect of a series of acupuncture treatments on subdimensions of neuropathic symptoms, such as pain, tingling and numbness. Neurophysiological testing of the affected nerves are incorporated into the study as a possible morphological correlate of functional and clinical findings.
Interventions
PROCEDUREacupuncture
semistandardized selection of acupuncture points according to the clinical presentation of diabetic peripheral neuropathy (DPN) symptoms; 12 treatments over 8 weeks
DRUGroutine care
pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)
Sponsors
Karl and Veronica Carstens Foundation
Benno Brinkhaus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The statistician will be blinded to the study intervention.
Intervention model description
multicenter, open label, randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
, among others: * Diagnosis of diabetic peripheral neuropathy in diabetes mellitus Type 2 * Males and females aged \>18yrs \< 70yrs * Minimum overall complaints of minimum 40mm on a visual analogue scale (VAS) * Completed titration of pain medication against diabetic peripheral neuropathy * Pathological nerve conduction velocity and amplitude of N. suralis ( \<42meter/second and or \< 6 mikroVolt)
Exclusion criteria
, among others: * Very severe diabetic peripheral neuropathy with muscular weakness of proximal leg muscles * Neuropathy due to other reasons such as borrelia infection, HIV, hereditary, alcohol toxic, or related to history of neurotoxic drugs. * Severe peripheral artery disease Fontaine stage IV * Ulcers or gangrenous lesions of the feet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue Scale (VAS) general complaints and pain | 8 weeks | Visual analogue Scale 100mm- ranging from 0mm no symptoms/ pain to 100mm worst imaginable symptoms or pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| -diabetic peripheral neuropathic pain Impact measure (DPNPI) | average of last week at baseline, 8, 16, 24 weeks | disease- specific Quality of Life- max sum score of 95; the higher the sum-score the higher the interference of diabetic peripheral neuropathy with activities of daily living. |
| Short-Form -12 (SF-12) | baseline , 8 weeks | 12 item Quality of Life- Questionnaire - different scores for subdimensions of daily living |
| pain perception Scale (SES german) | latest average at 8, 16, 24 weeks | emotional component of pain -scale- max sum score of 96- the higher the score the higher the negative emotional burden of pain experience. |
| neuropathic pain symptom inventory (NPSI ) | average of last 24h at baseline, 8, 16, 24 weeks | neuropathic pain symptom inventory- subdimensions of neuropathic pain are assessed in 10 of 11 Point numeric rating scales(NRS) |
| neurophysiological assessment of Nervus Suralis nerve conduction velocity | baseline, 8,16 and 24 weeks | measurements of nerve conduction velocity in meter per seconds (m/s)with device DPNCheck® Neurometrix® |
| neurophysiological assessment of Nervus Suralis height of amplitude of action potential | baseline, 8,16 and 24 weeks | height of amplitude of action potential of N. suralis in mikroVolt (µV) with device DPNCheck® from Neurometrix® |
| Patient global impression of Change (PGIC) | 8, 16 and 24 weeks | Scale from 1= very much improved to 7= very much worse |
Countries
Germany
Outcome results
None listed