J Dietzel1, S Hörder2, I V Habermann2, G Meyer-Hamme3, K Hahn4, M Ortiz2, S Roll2, K Linde5, D Irnich6, M Hammes7, R Nögel8, M Wullinger9, V Wortman10, J Hummelsberger11, S N Willich2, S Schröder3, B Brinkhaus2. 1. 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, Luisenstr. 57, 10117, Berlin, Germany. Joanna.Dietzel@charite.de. 2. 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, Luisenstr. 57, 10117, Berlin, Germany. 3. TCM-Zentrum am UKE, Breitenfelder Str. 15, 20251, Hamburg, Germany. 4. Department of Neurology with Experimental Neurology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany. 5. TUM School of Medicine, Institute of General Practice, Technical University of Munich, Munich, Germany. 6. Department of Anaesthesiology, Ludwig-Maximilians University (LMU), Marchioninistraße 15, Munich, Germany. 7. Praxis Dr.med. Michael Hammes, Louisenstraße 27a, Homburg, Germany. 8. Praxis Prof. Hempen & Kollegen, Fachärztliches Zentrum, Chinesische Medizin, Akupunktur, Franz-Joseph-Straße 38, 80801, Munich, Germany. 9. Praxis für chinesische Medizin, Rathausstr. 10, 83022, Rosenheim, Germany. 10. Praxis für TCM, Dilherrstr. 6, 90429, Nürnberg, Germany. 11. International Society for Chinese Medicine, Munich, Germany.
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.
RCT Entities:
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 IIpatients 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.
Entities:
Keywords:
Acupuncture; Chinese medicine; Complementary medicine; Peripheral neuropathy; Randomized controlled trial; Type II diabetes mellitus
Authors: C Witt; B Brinkhaus; S Jena; K Linde; A Streng; S Wagenpfeil; J Hummelsberger; H U Walther; D Melchart; S N Willich Journal: Lancet Date: 2005 Jul 9-15 Impact factor: 79.321