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| ID | Type | Description | Link |
|---|---|---|---|
| 1/183/18 | Other Identifier | ethics committee |
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| Name | Class |
|---|---|
| Karl and Veronica Carstens Foundation | OTHER |
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Multicentric,randomized, two-armed confirmatory trial on the effectiveness of acupuncture in patients with symptomatic peripheral diabetic neuropathy compared to routine care.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture plus routine care | Experimental | 12 session of semistandardized acupuncture together with pharmacological routine care |
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| routine care alone | Active Comparator | pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Procedure | semistandardized selection of acupuncture points according to the clinical presentation of diabetic peripheral neuropathy (DPN) symptoms; 12 treatments over 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue Scale (VAS) general complaints and pain | Visual analogue Scale 100mm- ranging from 0mm no symptoms/ pain to 100mm worst imaginable symptoms or pain | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| neuropathic pain symptom inventory (NPSI ) | neuropathic pain symptom inventory- subdimensions of neuropathic pain are assessed in 10 of 11 Point numeric rating scales(NRS) | average of last 24h at baseline, 8, 16, 24 weeks |
| -diabetic peripheral neuropathic pain Impact measure (DPNPI) |
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Inclusion Criteria, among others:
Exclusion Criteria, among others:
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| Name | Affiliation | Role |
|---|---|---|
| Benno Brinkhaus, MD, PhD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Universitätsmedizin Campus Mitte | Berlin | 10117 | Germany | |||
| Praxis für TCM am UKE |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18054725 | Background | 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. doi: 10.1016/j.ctim.2006.09.005. Epub 2006 Oct 30. | |
| 17355547 | Background |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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multicenter, open label, randomized
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The statistician will be blinded to the study intervention.
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| routine care | Drug | pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs) |
|
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. |
| average of last week at baseline, 8, 16, 24 weeks |
| Short-Form -12 (SF-12) | 12 item Quality of Life- Questionnaire - different scores for subdimensions of daily living | baseline , 8 weeks |
| pain perception Scale (SES german) | emotional component of pain -scale- max sum score of 96- the higher the score the higher the negative emotional burden of pain experience. | latest average at 8, 16, 24 weeks |
| Patient global impression of Change (PGIC) | Scale from 1= very much improved to 7= very much worse | 8, 16 and 24 weeks |
| neurophysiological assessment of Nervus Suralis nerve conduction velocity | measurements of nerve conduction velocity in meter per seconds (m/s)with device DPNCheck® Neurometrix® | baseline, 8,16 and 24 weeks |
| neurophysiological assessment of Nervus Suralis height of amplitude of action potential | height of amplitude of action potential of N. suralis in mikroVolt (µV) with device "DPNCheck®" from Neurometrix® | baseline, 8,16 and 24 weeks |
| Hamburg |
| 20251 |
| Germany |
| Schroder S, Liepert J, Remppis A, Greten JH. Acupuncture treatment improves nerve conduction in peripheral neuropathy. Eur J Neurol. 2007 Mar;14(3):276-81. doi: 10.1111/j.1468-1331.2006.01632.x. |
| 19420954 | Background | 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. |
| 40890741 | Derived | Bolster M, Dietzel J, Habermann IV, Horder S, Brinkhaus B, Stockigt B. Patients' experiences with acupuncture for diabetic polyneuropathy as part of a randomized controlled trial (ACUDPN) - a qualitative study. BMC Complement Med Ther. 2025 Sep 1;25(1):317. doi: 10.1186/s12906-025-05064-w. |
| 33637134 | Derived | Dietzel J, Horder S, Habermann IV, Meyer-Hamme G, Hahn K, Ortiz M, Roll S, Linde K, Irnich D, Hammes M, Nogel R, Wullinger M, Wortman V, Hummelsberger J, Willich SN, Schroder S, Brinkhaus B. Acupuncture in diabetic peripheral neuropathy-protocol for the randomized, multicenter ACUDPN trial. Trials. 2021 Feb 26;22(1):164. doi: 10.1186/s13063-021-05110-1. |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |