Acupuncture in diabetic peripheral neuropathy\u2014protocol for the randomized, multicenter ACUDPN trial

J Dietzel,S N Willich,M Ortiz,G Meyer-Hamme,K Linde,M Hammes,S Roll,S Hörder,S Schröder,V Wortman,J Hummelsberger,I V Habermann,M Wullinger,D Irnich,B Brinkhaus,K Hahn,R Nögel

doi:10.1186/s13063-021-05110-1

Abstract

BackgroundAcupuncture 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.MethodsThis 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.DiscussionThe 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 registrationClinicalTrials.gov NCT03755960. Registered on 11 August 2018.

Highlights

Acupuncture is used to treat patients with diabetic peripheral neuropathy; the evidence is unclear
To the best of our knowledge, the Acupuncture in Diabetic Peripheral Neuropathy (ACUDPN) study is the first clinical study to investigate the effectiveness of acupuncture treatment for diabetic peripheral neuropathy (DPN) compared to routine care alone in a multicenter two-armed clinical trial
To allow for the differentiation of the subdimensions of neuropathic pain, the Neuropathic Pain Symptom Inventory (NPSI) will be used in this study as a secondary outcome parameter

Summary

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. 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

Findings