Acupuncture in diabetic peripheral neuropathy—protocol for the randomized, multicenter ACUDPN trial
J. Dietzel,
S. Hörder,
I. V. Habermann,
G. Meyer-Hamme,
K. Hahn,
M. Ortiz,
S. Roll,
K. Linde,
D. Irnich,
M. Hammes,
R. Nögel,
M. Wullinger,
V. Wortman,
J. Hummelsberger,
S. N. Willich,
S. Schröder,
B. Brinkhaus
Affiliations
J. Dietzel
Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health
S. Hörder
Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health
I. V. Habermann
Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health
G. Meyer-Hamme
TCM-Zentrum am UKE
K. Hahn
Department of Neurology with Experimental Neurology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health
M. Ortiz
Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health
S. Roll
Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health
K. Linde
TUM School of Medicine, Institute of General Practice, Technical University of Munich
D. Irnich
Department of Anaesthesiology, Ludwig-Maximilians University (LMU)
M. Hammes
Praxis Dr.med. Michael Hammes
R. Nögel
Praxis Prof. Hempen & Kollegen, Fachärztliches Zentrum, Chinesische Medizin, Akupunktur
M. Wullinger
Praxis für chinesische Medizin
V. Wortman
Praxis für TCM
J. Hummelsberger
International Society for Chinese Medicine
S. N. Willich
Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health
S. Schröder
TCM-Zentrum am UKE
B. Brinkhaus
Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health
Abstract Background Acupuncture is used to treat patients with diabetic peripheral neuropathy; however, the evidence is unclear. We present the design and methodology of the ACUDPN (ACUpuncture in Diabetic Peripheral Neuropathy) trial, which investigates the effectiveness of acupuncture for the treatment of diabetic peripheral neuropathy (DPN) symptoms. The aim of this study is to investigate whether acupuncture is effective for the treatment of DPN symptoms. Methods This study is a two-armed, randomized, controlled, parallel group, open-label, confirmatory, multicenter trial (8-week intervention period plus 16 weeks of follow-up). Physicians in outpatient units in Germany who specialize in acupuncture treatment will treat 110 diabetes type II patients with clinical symptoms of peripheral neuropathy in the feet and legs with signs of neuropathy according to nerve conduction testing. The patients will be randomized in a 1:1 ratio to one of the following two groups: (a) semi-standardized acupuncture plus routine care or (b) routine care alone. Acupuncture will consist of 12 treatments per patient over 8 weeks. The primary outcome will be the overall DPN-related complaints in the extremities after 8 weeks as measured by the Visual Analog Scale (VAS). Further outcome measures will include DPN-related pain, the Neuropathic Pain Symptom Inventory (NPSI), Diabetic Peripheral Neuropathic Pain Impact (DPNPI) scores, and nerve conduction parameters of the sural nerve at weeks 8, 16, and 24. Discussion The results of this trial will be available in 2021 and will help clarify whether acupuncture can be considered effective for the treatment of DPN with regard to the subdimensions of the neuropathic clinical picture. Trial registration ClinicalTrials.gov NCT03755960 . Registered on 11 August 2018.
