ACUDPN: ACUpuncture in Diabetic Peripheral Neuropathy
Study Details
Study Description
Brief Summary
Multicentric,randomized, two-armed confirmatory trial on the effectiveness of acupuncture in patients with symptomatic peripheral diabetic neuropathy compared to routine care.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: acupuncture plus routine care 12 session of semistandardized acupuncture together with pharmacological routine care |
Procedure: acupuncture
semistandardized selection of acupuncture points according to the clinical presentation of diabetic peripheral neuropathy (DPN) symptoms; 12 treatments over 8 weeks
Drug: routine care
pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)
|
Active Comparator: routine care alone pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs) |
Drug: routine care
pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
- -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.
- Patient global impression of Change (PGIC) [8, 16 and 24 weeks]
Scale from 1= very much improved to 7= very much worse
- 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®
Eligibility Criteria
Criteria
Inclusion Criteria, among others:
-
Diagnosis of diabetic peripheral neuropathy in diabetes mellitus Type 2
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Males and females aged >18yrs < 70yrs
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Minimum overall complaints of minimum 40mm on a visual analogue scale (VAS)
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Completed titration of pain medication against diabetic peripheral neuropathy
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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
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Neuropathy due to other reasons such as borrelia infection, HIV, hereditary, alcohol toxic, or related to history of neurotoxic drugs.
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Severe peripheral artery disease Fontaine stage IV
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Ulcers or gangrenous lesions of the feet
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Charité Universitätsmedizin Campus Mitte | Berlin | Germany | 10117 | |
2 | Praxis für TCM am UKE | Hamburg | Germany | 20251 |
Sponsors and Collaborators
- Benno Brinkhaus
- Karl and Veronica Carstens Foundation
Investigators
- Principal Investigator: Benno Brinkhaus, MD, PhD, Charite University, Berlin, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
- Schröder S, Liepert J, Remppis A, Greten JH. Acupuncture treatment improves nerve conduction in peripheral neuropathy. Eur J Neurol. 2007 Mar;14(3):276-81.
- Weidenhammer W, Streng A, Linde K, Hoppe A, Melchart D. Acupuncture for chronic pain within the research program of 10 German Health Insurance Funds--basic results from an observational study. Complement Ther Med. 2007 Dec;15(4):238-46. Epub 2006 Oct 30.
- Witt CM, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, Willich SN. Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed. 2009 Apr;16(2):91-7. doi: 10.1159/000209315. Epub 2009 Apr 9.
- ACUDPN
- 1/183/18