Acupuncture in diabetic peripheral neuropathy-protocol for the randomized, multicenter ACUDPN trial

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.

Keywords: Acupuncture; Chinese medicine; Complementary medicine; Peripheral neuropathy; Randomized controlled trial; Type II diabetes mellitus.

Fig. 1

Participant timeline {13}. Time schedule, design, and outcome parameters of the ACUDPN study. BL, baseline; W8, W16, etc., week 8, week 16, etc., after inclusion in the study. Outcome measures: VAS pain and VAS overall DPN-related complaints, German versions of the Neuropathic Pain Symptom Inventory (NPSI), Diabetic Peripheral Neuropathic Pain Impact (DPNPI) measure, the emotional pain perception scale (SES), the SF-12 QoL, the Patient Global Impression of Change (PGIC), and neurological exam with clinical Total Neuropathy Score (cTNS)

Fig. 2

Obligatory acupuncture points used in the ACUDPN study (modified from Stux, G. Akupunktur Lehrbuch und Atlas, Springer Verlag Berlin Heidelberg, 2008 with permission)