Gesa Meyer-Hamme, Thomas Friedemann, Henry Johannes Greten, Rosemarie Plaetke, Christian Gerloff & Sven Schroeder 

BMC Neurology volume 18, Article number: 40 (2018) Cite this article

Abstract

Background

Diabetic peripheral neuropathy (DPN) is the most common complication of diabetes mellitus with significant clinical sequelae that can affect a patient’s quality of life. Metabolic and microvascular factors are responsible for nerve damage, causing loss of nerve function, numbness, painful sensory symptoms, and muscle weakness. Therapy is limited to anti-convulsant or anti-depressant drugs for neuropathic pain and paresthesia. However, reduced sensation, balance and gait problems are insufficiently covered by this treatment. Previous data suggests that acupuncture, which has been in use in Traditional Chinese Medicine for many years, may potentially complement the treatment options for peripheral neuropathy. Nevertheless, more objective data on clinical outcome is necessary to generally recommend acupuncture to the public.

Methods

We developed a study design for a prospective, randomized (RCT), placebo-controlled, partially double-blinded trial for investigating the effect of acupuncture on DPN as determined by nerve conduction studies (NCS) with the sural sensory nerve action potential amplitude as the primary outcome. The sural sensory nerve conduction velocity, tibial motor nerve action potential amplitude, tibial motor nerve conduction velocity, the neuropathy deficit score, neuropathy symptom score, and numeric rating scale questionnaires are defined as secondary outcomes. One hundred and eighty patients with type 2 diabetes mellitus will be randomized into three groups (needle acupuncture, verum laser acupuncture, and placebo laser acupuncture). We hypothesize that needle and laser acupuncture have beneficial effects on electrophysiological parameters and clinical and subjective symptoms in relation to DPN in comparison with placebo.

Discussion

The ACUDIN trial aims at investigating whether classical needle acupuncture and/or laser acupuncture are efficacious in the treatment of DPN. For the purpose of an objective parameter, NCS were chosen as outcome measures. Acupuncture treatment may potentially improve patients’ quality of life and reduce the socio-economic burden caused by DPN.

Relevant extracts (see link for more detail):

Clinical manifestations include paresthesia, burning sensations, and neuropathic pain as well as negative symptoms like hypesthesia, hypalgesia, and pallhypesthesia. These may contribute to balance problems and unsteady gait, leading to falls [6] and an increased risk of bone fractures and hospitalization [7]. Motor symptoms, for example muscle spasm and weakness occur less frequently [3]. DPN is associated with an increased risk of ulceration and amputation of the lower extremities as well as increased healthcare costs [8,9,10]. Nerve damage can occur on the myelin sheath as well as at the axonal level [11]. Differentiation is achieved by nerve conduction studies (NCS) [12]. Whilst neuropathic pain and paresthesia can be palliated by anti-convulsants, tricyclic antidepressant drugs or serotonin-noradrenalin re-uptake inhibitors [13], pharmacologic management of decreased sensation is generally ineffective, thus forming a gap in treatment strategies.

During the last decades, acupuncture has become an empirical complementary treatment option for DPN. It is recommended by the World Health Organisation [14] and the National Institute of Health [15] but treatment effectiveness is still under debate. Reviews concerning acupuncture for peripheral neuropathy (PN) have found that, despite the majority of studies reporting positive results, a reliable statement of effectiveness is not possible due to methodological limitations [16,17,18,19,20,21,22]. Randomized controlled, blinded clinical trials of adequate statistical power and design are still pending.

Whilst acupuncture concepts using proximal or systemic acupuncture points on upper and lower extremities failed to show efficacy [23], our pilot studies using the selection of local and distal points described here showed promising results for the treatment of DPN, chemotherapy-induced PN and PN of unknown cause(s). These studies have verified the improvement that can be found in subjective scales by means of NCS parameters [24,25,26,27]. Acupuncture has been shown to increase blood perfusion towards the periphery of the limbs following needle insertion [28]. The results of our pilot studies were potentially related to the acupuncture effect on the blood flow through vasa nervorum and dependent capillary beds supplying the neurons [26]. These findings are encouraging for setting up the framework of a clinical study of adequate sample size using strict methodological standards.

ACUDIN acupuncture protocol

A total of 20 acupuncture points have been selected for the ACUDIN trial. All treatment sessions of needle and laser acupuncture are performed using the following point combination:

The 4 Bafeng points on both feet (Ex-LE-10) [47]. Needles are inserted to a depth of 3 to 5 mm and left in place without stimulation for 20 min. Laser needles are fixed with perforated plaster.

The 5 Qiduan points on both feet (Ex-LE-12) [47]. Needles are inserted to a depth of 1,5 to 2 mm and left in place without stimulation for 20 min. Laser needles are fixed with perforated plaster (Fig. 2).

figure2
Fig. 2

The point Lianqiu on both legs (ST-34) [47]. Needles are inserted to a depth of 0,5 to 2.5 cm (depending on the diameter of the thigh) and left in place without stimulation for 20 min. Laser needles are fixed with perforated plaster.

Sterile single-use stainless steel needles size 0,2 × 15 mm are used for Qiduan and Bafeng points, respectively 0,3 × 30 mm for Lianqiu, both manufactured by Wujiang City Cloud & Dragon Medical Devise Co. Ltd, China.

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