Complementary Therapies in Clinical Practice 44 (2021) 101442

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Complementary Therapies in Clinical Practice

journal homepage: www.elsevier.com/locate/ctcp

The effects of auricular acupuncture on vascular parameters on the risk

factors for diabetic foot: A randomized clinical trial
Bianca Bacelar de Assis a, 1, *, Erika de Cássia Lopes Chaves a, Ligia de Sousa a, b,
Tânia Couto Machado Chianca c, Juliana Bassalobre Carvalho Borges b,
Andréia Maria Silva Vilela Terra b, Thaila Oliveira Zatiti Brasileiro a, Mariana Fulanetti Costa b,
Fabio Cabral Pereira b, Paloma Elisama de Oliveira d, Caroline de Castro Moura e, 2,
Denise Hollanda Iunes a, b
a
Nursing School and Postgraduate Program in Nursing of Federal University of Alfenas. 700 Gabriel Monteiro da Silva St., Alfenas, Minas Gerais, 37130-001, Brazil
b
Motor Science Institute and Postgraduate Program in Rehabilitation Sciences of Federal University of Alfenas. 2600 Jovino Fernandes de Sales Ave., Alfenas, Minas
Gerais, 37133-840, Brazil
c
Nursing School and Postgraduate Program in Nursing of Federal University of Federal University of Minas Gerais. 190 Prof. Alfredo Balena St., Belo Horizonte, Minas
Gerais, 30130-100, Brazil
d
Nursing School of the Federal University of Alfenas. 700 Gabriel Monteiro da Silva St., Alfenas, Minas Gerais, 37130-001, Brazil
e
PhD Student in Nursing at the Federal University of Minas Gerais. 190 Prof. Alfredo Balena St., Belo Horizonte, Minas Gerais, 30130-100, Brazil

A R T I C L E I N F O A B S T R A C T

Keywords: Aims and objectives: To evaluate the effects of auricular acupuncture on vascular parameters on the risk factors for
Acupuncture Diabetic Foot.
Ear. diabetes mellitus Methods: Randomized and masked clinical trial. The sample was composed of 44 individuals with type 2 Diabetes
Type 2. diabetic foot
Mellitus and they were randomly assigned to two groups: intervention (n = 22), which received five sessions of
Nursing
auricular acupuncture, and control (n = 22), which did not receive the therapy. Three evaluations were per­
Rehabilitation
formed: before the intervention; one day after the last acupuncture session and 15 days after the second eval­
uation. For this, the subject’s characterization instrument, the Ankle-Brachial Index measurement, and
thermography were used. For data analysis, Mann-Whitney, Wilcoxon, Wilcoxon signed-rank, Fisher’s Exact and
Chi-Square tests were used.
Results: Auriculotherapy provided results in the Ankle-Brachial Index Test, as well as in thermography, which
showed significant temperature improvement.
Conclusions: The technique proved to be efficient in improving circulatory conditions and plantar temperature.

1. Introduction major burdens in public healthcare services, as it affects organs and

systems, causing metabolic disorders, cardiovascular complications,
Type 2 Diabetes Mellitus (DM2) is characterized by being one of the neuropathy, retinopathy, and diabetic foot syndrome [1,2].

* Corresponding author. School of Nursing - Federal University of Alfenas - 700 Gabriel Monteiro da Silva St. 37130-00. Alfenas, Minas Gerais. Brazil. Tel.: +(35)
3701-9471
E-mail addresses: bibacelar@hotmail.com (B. Bacelar de Assis), echaves@unifal-mg.edu.br (E. de Cássia Lopes Chaves), ligiaunifal@gmail.com (L. de Sousa),
taniachianca@gmail.com (T.C. Machado Chianca), juliana.borges@unifal-mg.edu.br (J.B. Carvalho Borges), andreia.silva@unifal-mg.edu.br (A.M. Silva Vilela
Terra), thailazatiti@hotmail.com (T.O. Zatiti Brasileiro), mariana.fulanetti@gmail.com (Mariana Fulanetti Costa), fabio_cabral_pereira@hotmail.com (Fabio
Cabral Pereira), paloma.oliveira@sou.unifal-mg.edu.br (P. Elisama de Oliveira), carol_castro_m@hotmail.com (C. de Castro Moura), deniseiunes@unifal-mg.edu.
br (D.H. Iunes).
1
Bianca Bacelar de Assis - PhD student in the Postgraduate Program in Nursing at the Federal University of Minas Gerais. 190 Prof. Alfredo Balena St., Belo
Horizonte, Minas Gerais, 30130-100, Brazil.
2
Caroline de Castro Moura – Professor of Department of Medicine and Nursing, Federal University of Viçosa. Av. Peter Henry Rolfs, Viçosa, Minas Gerais, 36570-
900, Brazil.

https://doi.org/10.1016/j.ctcp.2021.101442
Received 10 November 2020; Received in revised form 28 June 2021; Accepted 9 July 2021
Available online 11 July 2021
1744-3881/© 2021 Elsevier Ltd. All rights reserved.
B. Bacelar de Assis et al.
The costs of treating the consequences of Diabetes are high. A recent
study on outpatient appointments carried out in healthcare services in
the United States found that 784.8 million appointments were related to
Diabetes care and 6.7 million of these appointments were due to Dia­
betic Foot Ulcer treatment. These ulcers are associated with a 3.4 times
greater chance of direct admission into emergency or hospitalization
and a 2.1 times greater chance of referral to another medical practitioner
[3]. The treatment, when compared to prevention, indicates that for
each euro spent on ulcer prevention, ten are spent on healing and re­
covery [4], which characterizes a significant burden on the healthcare
budget.
DM2 is related to insulin resistance and obesity, corresponding to
90% of Diabetes cases [5]. Among the complications caused by the
disease, Diabetic Foot has great relevance, especially when associated
with Peripheral Arterial Disease (PAD), which represents a significant
increase in the risk factors for atherosclerotic cardiovascular disease,
chronic renal deficiencies, and reduced survival [5,6].
To encourage the prevention of diseases stemming from DM, the use
of a non-pharmacological approach, such as auricular acupuncture, as
part of Integrative and Complementary Practices (PIC), is identified in
the literature as a considerable practice [7].
As far as literature is concerned, it is noted that this subject is under-
explored and the number of studies with an experimental design that
uses auricular acupuncture for the prevention or rehabilitation of the
vascular complications caused by Diabetic Foot is limited.
In the field of Nursing, it is possible to notice that clinical research
has been growing, however, there is still a gap between research and
practice. Thus, there is difficulty in implementing Evidence-Based
Practice (EBS) in the nurses’ work processes and professional routine.
In face of this, these practitioners recognize that they need to improve
their knowledge and skills to be active participants in EBS [8].
Faced with this scenario, a greater number of scientific evidence is
needed that can promote knowledge regarding auricular acupuncture as
an intervention tool in the prevention and/or rehabilitation of changes
in circulatory conditions on risk factors for Diabetic Foot, as well as for
the promotion of quality of life. Therefore, this study aimed to evaluate
the effects of auricular acupuncture on vascular parameters of risk fac­
tors for Diabetic Foot.
2. Methods
2.1. Study design
This is a randomized, masked clinical trial, following CONSORT
(2010) [9] guidelines, carried out from August to December 2017.
2.2. Study population and participant eligibility criteria
The population was composed of people with DM2, who were
registered in the Vivver/E-SUS System in the Primary Healthcare units
of a city in the south of Minas Gerais. The presence of DM2 for at least
five years was established as a screening criterion. Therefore, out of the
population of 2987 people with DM registered in healthcare units, a
total of 831 people were eligible for this study.
The inclusion criteria established were the following: age ≥18 years
and time availability for submission to the intervention sessions. The
exclusion criteria were the following: to be suffering from any form of
infection, inflammation, or injury in the auricular pavilion, to use
piercings (excluding normal earrings), to be allergic to metal or micro­
pore, to refuse to receive auricular treatment through needles, to be
pregnant, to have been through a process of total or partial amputation
and/or the presence of any lesion in the lower limbs, to be suffering from
thrombosis in the lower limbs and not responding to three contact at­
tempts made by the researcher.
The eligible sample was contacted by telephone to verify their in­
terest and willingness to participate in the survey. Then, 44 people with
2
Complementary Therapies in Clinical Practice 44 (2021) 101442
DM2 composed the final sample and were randomly assigned to two
study groups: the intervention group (IG) (n = 22) that received the
auricular acupuncture treatment and the control group (CG) (n = 22)
that did not receive the treatment. Sample recruitment is shown in
Fig. 1.
2.3. Sample size
A pilot test was carried out with a homogeneous group consisting of
six research subjects in each group to estimate the minimum sample size.
For this purpose, the n= Z ​ αE/2.σ formula and the R Core Team version
3.2.4 program were used. The variable selected was the Ankle-Brachial
Index, which obtained 10.42, i.e. 11 individuals per group, employing
the highest variation coefficient. It was considered a statistical power of
95%. To avoid sample losses, the number of subjects was increased.
Therefore, the final sample consisted of 22 people, with a loss of 18.18%
(n = 4 individuals), whereas the IG loss resulted from the dropout from
the second session onwards, and the CG losses resulted from the absence
in the final evaluation.
2.4. Randomization procedure
An independent researcher was responsible for assigning subjects
randomly to both groups using the Random.org program. Initially, a
sequence of random numbers was generated in the R version 3.1.1
software, and each individual received this randomized number as they
attended the initial evaluation. Subsequently, the interventionist
received two opaque envelopes, sealed with the numbers generated by
Random.org which defined to which group the research subject had been
allocated to.
2.5. Data collection
Participants were evaluated in session zero before starting the
treatment; the final evaluation was carried out the day after the needles
were removed in the last session (fifth session) and the follow-up was
carried out 15 days after the treatment was completed. All three eval­
uations were carried out by the same researcher who was properly
trained to collect data, unaware of the allocation of research subjects in
the groups, which characterized the masking of the study.
A questionnaire was developed by the researchers to characterize the
subjects, which contained sociodemographic aspects: identification of
the research subjects as sex, and age; clinical aspects: DM2 diagnosis
time, the type of treatment, whether the feet have already been evalu­
ated by a healthcare practitioner, whether they have already received
instruction on foot care, whether they have self-reported arterial hy­
pertension and association of other diseases; glycosylated hemoglobin
(HbA1c) rate from the most recent test and capillary glycemia at the
time of evaluation.
2.6. Primary outcome
The Ankle-Brachial Index (ABI) was used to investigate the circula­
tory condition of lower limbs. This test is considered a non-invasive and
efficient method to determine the vascular conditions in the lower limbs
and to verify the presence of PAD [11].
The Ankle-Brachial Index is analyzed by dividing the value of the
lower limb systolic blood pressure by the highest brachial systolic blood
pressure value. An ABI ≤0.9 is considered to be the threshold for PAD
diagnosis. The normality score for adults ranges from 1.0 to 1.4 [12].
For this purpose, the Portable Vascular Doppler device - Medpej - DV-
2001 model was used, with a 10mhz frequency; the aneroid sphygmo­
manometer, which is a high precision manometer (0–300 mmHg), and a
clamp with 18–35 cm circumference; and finally, the conductive gel
were all used, as well. The evaluation was performed in the posterior
B. Bacelar de Assis et al.
Fig. 1. Flowchart of sample progress through study phases.
Tibial or Pediosa arteries since both characterize the blood flow of the
feet [13].
The examination was performed with the research subject at rest for
at least 5 min in dorsal decubitus position; an adequately sized clamp
was used, i.e., with at least 40% of the lower limb circumference, and
positioned 2 cm above the medial malleolus; the Doppler probe was
positioned at an angle of 45–60◦ on the skin over one of the distal ar­
teries. The systolic blood pressure was measured by inflating the clamp
up to 2–3 mmHg above the level at which blood flow ceased, slowly
deflating the clamp until the pulsatile return occurred [14].
2.7. Secondary outcomes
The secondary outcome was the temperature, which was measured
by a thermographic assessment. The assessment of skin temperature
with Infrared Thermography (IRT) is considered an efficient means of
observing heat distribution on the body surface. It is a safe, painless, and
effective imaging exam to predict and prevent Diabetic Foot Ulcers [15].
Imaging was performed by a Flir Systems® infrared sensor with
digital image processing capabilities, thermal sensitivity of 0.08 ◦ C, in a
spectral range of 3–14 μm, suitable for application in clinical diagnosis.
The photos were recorded in a room with an ambient temperature of
22 ◦ C for 20 min, where sunlight was absent and the illumination was
provided by cold-cathode fluorescent lamps.
The research subjects were positioned in the dorsal decubitus posi­
tion, their feet were positioned in dorsiflexion and a thermal insulation
box was placed over the calves, leaving only the feet area exposed. The
camera was positioned 0.98 m away from the research subjects and at a
height of 0.95 m from the floor supported by a built-in device. A period
of 15 min of exposure was expected for the skin to enter into thermal
balance with the room temperature [16].
Later, three images were captured [17]. The support software Ve­
locity 2.3 with automatic calibration was used for data analysis.
3
Complementary Therapies in Clinical Practice 44 (2021) 101442
2.8. Intervention
The Standards for Reporting Interventions in Clinical Trials of
Acupuncture [18] guidelines were followed to establish a protocol for
acupuncture treatment, which was evaluated by five judges with expe­
rience in acupuncture after its development. All the considerations made
by these judges were complied with: five sessions for treatment; the use
of semi-permanent needles; the use of the following auricular points:
Shenmen, Kidney, Spleen [19]; Endocrine [20]; Vagus Nerve [21]; Foot,
Sympathetic Nervous System, Pancreas; Liver, Hypophysis.
The IG participants received the auricular acupuncture treatment
through the use of semi-permanent needles from the Complementar
Agulhas brand, with a 1.5 mm size, which was performed by a practi­
tioner trained in auricular acupuncture with five years of experience.
The treatment consisted of five sessions that took place once a week,
with alternation of the auricular pavilion at each session.
For greater methodological rigor, the correct location of the auric­
ular points was confirmed with the Acu-Treat locator, from the DongBan
brand, prior to needle insertion. Then, the auricular pavilion antisepsis
was performed using cotton and 70% isopropyl alcohol and, subse­
quently, the semi-permanent sterile needles were inserted in each one of
the auricular points carefully and were fixated with beige microporous
tape.
2.9. Statistical analysis
The data were analyzed by Intention to Treat, according to the
CONSORT guidelines [10], the repetition of values from the last eval­
uation protocol was employed. The Shapiro Wilk test was used for the
analysis to determine data normality. Wilcoxon signed-rank tests were
used for non-parametric data. Fisher’s Exact and Chi-Square tests were
also used for dichotomous data. A 95% confidence interval was
employed, with an error margin of 0.05 points.
B. Bacelar de Assis et al. Complementary Therapies in Clinical Practice 44 (2021) 101442

2.10. Ethical considerations Table 2

Sample characterization of HbA1c and capillary glycemia rates.
The study was approved by the local Human Research Ethics Com­ Variables IG (n = 22) CG (n = 22) p-
mittee under the legal opinion 2.138.277/CAAE 69907817100005142. valuea
After the follow-up period, subjects from the control group were offered Glycosylated 7.60% (6.77–8.77) 7.10% (6.67–8.32) 0.664
the same treatment available to the intervention group. All participants Hemoglobin (Hba1c)
provided written consent prior to participating in this study. Median (interquartile)
Capilary Glycemia 179.00 mg/dl 214.5 mg/dl 0.869
Mediana (interquartile) (124.75–262.25) (131.00–259.50)
3. Results
a
Mann-Whitney test.
The sociodemographic variables and clinical variables analyzed were
homogeneous among the groups, and consequently, the randomization 4. Discussion
process was adequate (Table 1).
The medications used for the DM2 treatment by the research subjects The borderline considered by the ABI test for the characterization of
were sulphonylureas and biguanides. All participants were encouraged blood flow conditions is 0.9, in which the values below it are considered
to follow the medication treatment they were already following before as PAD, and the lower the index, the more severe the impairment, which
the intervention so that their hyperglycemic state would not worsen and can lead to severe heart diseases and stroke [22]. Ideally, individuals
interfere with the results. should stay in the range between 0.9 and 1.4, which was characteristic
All the other self-reported diseases were heart disease, obesity, and a in the present study, even if the subjects presented a significant reduc­
past history of cancer. However, it is worth mentioning that all comor­ tion in the ABI. This fact can be described as positive since it allowed the
bidities presented by the research participants were stable. No treatment intervention group to remain within the standardized limits to avoid
was carried out on subjects with acute pathologies that could interfere PAD.
with the study’s outcomes. The auricular electro acupuncture modality is a therapy that is
The examinations regarding the Glycosylated Hemoglobin (HbA1c) similar to the one used in the present study, and it was used in a clinical
and capillary glycemia measurement rates have demonstrated homo­ trial for PAD treatment and presented favorable results. Auricular nee­
geneity in both groups (Table 2). dles were used in the vagus nerve acupoint with electrical stimulation
The blood flow evaluated by the ABI in both feet and presented in and relief was obtained in the intermittent claudication symptoms,
Table 3, presented a reduction in the three evaluation instances in the which are typical of this pathology. This improvement may be related to
two groups. In the intervention group, there was a significant difference the intervention that provided a transient change in the blood flow of the
in the analysis between the initial and follow-up evaluations of the right innervation of this auricular region, which favored the re-establishment
foot. The intergroup evaluation did not present significant results. of intermittent claudication [23].
The evaluation of the tissue temperature of the right foot, obtained Approaches for the improvement of oxidative stress are also of
through thermography, pointed out statistically significant modifica­ paramount importance for the treatment and management of PAD as
tions for the intragroup analysis, which showed a decrease at the one of the prevention measures for DM aggravations. Oxidative stress,
moment of the final evaluation and, later, an increase at the moment of induced by hyperglycemia, impairs the endothelial lining of blood ves­
follow-up. Thus, it was noted that the temperature decreased between sels and compromises the nitric oxide (NO) functions, which are: to
the initial and final evaluations and that in the comparison between the promote the relaxation of the arterial smooth muscle and to allow
initial and follow-up evaluations the temperature increased in the IG. In vasodilation and blood flow increase; to act as an antioxidant to
relation to the Left Foot, there was a significant statistical change in the compensate the overproduction of reactive oxygen species (ROS) pro­
comparison between the final and follow-up evaluations of the IG, which duced in the mitochondria during regular oxidative phosphorylation;
presented an increase in temperature (Table 4). and to protect the blood vessels from atherosclerotic plaque formation,
which inhibits platelet aggregation [24].
With the intention of promoting the reduction of oxidative stress and
the improvement of blood flow conditions, acupuncture has been stud­
ied and stands out as a plausible practice for dealing with these issues.
Table 1
An experimental approach study carried out with hypertensive rats [25],
Sample characterization regarding sociodemographic and clinical variables.
has evidenced that systemic electro acupuncture has provided an
Variables IG (n = 22) CG (n = 22) p-value
improvement in oxidative stress, in the bioavailability of NO, and in
Sex – f (%) Female 13 (59.1) 17 (77.3) 0.332a endothelial function in animals. However, the number of studies on
Male 9 (40.9) 5 (22.7) auricular acupuncture in this aspect of the bioavailability of NO is still
Age (years) Average 61.23 (9.4) 62.73 (10.6) 0.622b
(SD)
limited.
Diagnosis Time (years) Average 14.91 (12.09) 10.45 (6.31) 0.136b The importance of tissue perfusion must also be emphasized as a
(SD) consequence of PAD in diabetic patients. PAD leads to a low perfusion
Oral Antidiabetics User – f (%) Yes 20 (90.9) 20 (90.9) 1.000a reserve of the lower limb and decreases parallel to the decrease of
No 2 (9.1) 2 (9.1)
vascular dilation and permeability, based on the thickening of the basal
Insulin User – f (%) Yes 9 (40.9) 5 (22.7) 0.332a
No 13 (59.1) 17 (77.3) capillary membrane [26]. In these cases, successful prevention and
Had their feet evaluated by a Yes 11 (50.0) 11 (50.0) 1.000c treatment of foot ulcers can increase lower limbs perfusion as a revas­
practitioner – f (%) No 11 (50.0) 11 (50.0) cularization procedure [27].
Received instructions on foot Yes 12 (54.5) 13 (59.1) 0.366c As a consequence of peripheral vascular alteration, contraction or
care – f (%) No 10 (45.5) 9 (40.9)
Systemic Arterial Hypertension Yes 19 (86.4) 17 (77.3) 0.698a
dilatation of vessels can happen, a process by which the human body
– f (%) No 3 (13.6) 5 (22.7) temperature is maintained or lost. The temperature distribution over the
Other diseases – f (%) Yes 13 (59.1) 11 (50.0) 0.546c skin of the limbs varies depending on whether the body is maintaining or
No 9 (40.9) 11 (50.0) dissipating heat [28].
a
Fisher’s Exact test. Therefore, the tissue temperature is an important evaluation aspect
b
T-test. of the vascular parameters of the Diabetic Foot. For this purpose, the use
c
Chi-squared test. of tools to identify early signs of foot ulcers has the potential to reduce

4
B. Bacelar de Assis et al. Complementary Therapies in Clinical Practice 44 (2021) 101442

Table 3
Intergroup and Intragroup analyses related to blood flow evaluation by the ABI test.
ABI GROUPS INTERGROUP ANALYSIS INTRAGROUP ANALYSIS p-valuea

Pre Median (interquartile) Post Median (interquartile) Follow-up Median (interquartile) Pre/ Post/Follow- Pre/Follow-
Post up up

Right foot IG (n ¼ 22) 1.14 (1.04–1.28) 1.13 (1.04–1.28) 1.09 (1.01–1.14) 0.116 0.227 0.007c
CG (n ¼ 22) 1.23 (1.09–1.38) 1.10 (1.05–1.26) 1.10 (1.04–1.28) 0.072 0.528 0.122
p-valueb 0.145 0.622 0.378
Left foot IG (n ¼ 22) 1.10 (1.00–1.20) 1.10 (0.96–1.18) 1.05 (1.02–1.19) 0.809 0.559 0.147
CG (n ¼ 22) 1.19 (1.06–1.38) 1.12 (0.99–1.21) 1.10 (1.00–1.20) 0.139 0.794 0.063
p-valueb 0.051 0.725 0.341
a
Wilcoxon test.
b
Mann-Whitney test.
c
Statistical significance.

Table 4
Intergroup and Intragroup analysis regarding thermography.
Thermo- GROUPS INTERGROUP ANALYSIS INTRAGROUP ANALYSIS p-valueb
graphy
Pre (oC) Median Post (oC) Median Follow-up (oC) Median Pre/ Post/Follow- Pre/Follow-
(interquartile) (interquartile) (interquartile) Post up up

Right foot GI (n ¼ 22) 26.25 (23.34–31.49) 26.26 (23.33–29.24) 26.79 (25.69–28.91) <0.001c 0.829 <0.001c
GC (n ¼ 25.76 (24.24–28.75) 25.78 (24.26–28.76) 26.19 (25.04–29.33) 0.721 0.149 0.131
22)
Valor pa 0.944 0.981 0.565
Left foot GI (n ¼ 22) 26.34 (23.58–31.69) 26.89 (25.29–31.15) 27.75 (26.12–30.31) 0.200 0.036c 0.178
GC (n ¼ 24.76 (24.08–28.42) 27.31 (24.84–29.76) 27.51 (25.85–28.84) 0.003c 0.223 0.006c
22)
Valor pa 0.519 0.565 0.348
a
Mann-Whitney test.
b
Wilcoxon signed-rank test.
c
Statistical significance.

the incidence of complications and even amputations. Thus, thermom­
etry is a promising specificity to evaluate and manage previous signs of
complications and help prevent foot lesions [29].
It was possible to identify signs of considerable changes in the
plantar temperature through thermography in the present study. The
index presented by both groups was low. Even if the right lower limb
presented a reduction in temperature after acupuncture therapy, there
was also an important increase after the follow-up period. The left foot,
in turn, presented significant improvement right after the proposed
intervention.
According to Renero [28], there is a reduction of blood flow in the
vessels in regions with lower skin temperatures. This decrease in local
blood volume can be a consequence of sensitivity loss, or the constric­
tion or dilation of blood vessels that occurs partially. Thus, the cold
region of the plantar skin can be considered a risk tissue where further
complications and aggravations such as trauma and infections can
occur.
It is necessary to increase the plantar temperature within normal
levels to treat and/or prevent ulcers in cases of foot ischemia, as
demonstrated in the present study since it assists in improving blood
flow and oxygen availability [30].
The relation between auricular acupuncture therapy and improved
peripheral tissue oxygenation is still limited. However, there is a close
relation between improved tissue perfusion and plantar temperature.
Regarding tissue perfusion, it is known that hyposecretion or inactiva­
tion of NO, induced by vascular endothelial dysfunction is considered as
the important factor involved in the pathogenesis and progression of
vascular diseases [31].
In this study, acupuncture therapy was considered safe, since no
adverse events presented by the research subjects have happened during
the treatment period. The literature corroborates this finding. In a sys­
tematic review, 18 studies on adverse events were found, involving 1753
patients and did not record any serious adverse events. However, minor
short-term occurrences were identified, such as pain, nausea, dizziness,
local bleeding, and mild inflammation, in which they were considered
transient, secondary, and tolerable [32].
The choice to carry out the study without a placebo group, with
stimulus applied to points not related to acupuncture, is due to the fact
that the use of this sham method as a placebo presents itself as a great
hindrance since it is difficult to characterize it as totally inactive [33].
The experts’ choice of points was supported by the importance of
each one in the treatment protocol. The “Shenmen” stimulates the release
of endorphins in the brain, relieving pain and discomfort. This point
should be applied alongside the “Sympathetic Nervous System” point,
which is indicated for circulatory alterations, neurovegetative disorders,
and visceral pain. The “Kidney” is a point of balance of the Yin energy, it
strengthens the vital energy. The “Spleen” is a central energy point and is
indicated for patients with DM. The “Endocrine” point is indicated for the
treatment of hypofunction and hyperfunction of internal secretion
glands, as for insulin regulation, for instance [34]. The “Vagus Nerve” is a
point used in cases of disturbances of the vagus-sympathetic system,
compulsive hunger, obesity treatment, and so forth. The “Foot” point is
indicated for the treatment of plantar pain, calcaneal spur, fissures in the
heel skin, mycosis, paralysis of the lower limbs, foot cramps, circulation
deficiency, tissue necrosis, and so on. The “Pancreas” point is indicated
in cases of pancreatic deficiency, protein metabolism deficiency, being
indispensable in cases of DM. The “Liver” point is a point often used for
food intolerances and therefore can assist in the treatment of DM dis­
orders. Finally, the use of the “Hypophysis” point is justified since it is
indicated in cases of neuro-vegetative disorders, DM, and obesity [34].
Finally, there is a consensus that it is possible to implement auric­
ulotherapy, along with other PIC, in nursing care practice. Furthermore,
these practices have proved to be effective both in rehabilitation sce­
narios, through the person-centered approach, as well as for the pre­
vention of aggravations and as a facilitator for therapeutic alternatives
[35].

5
B. Bacelar de Assis et al.
Some aspects limit the final evidence on the effectiveness of auricular
therapy in the prevention of Diabetic Foot. Due to the existence of
comorbidities, the population, even with medication-controlled pat­
terns, may present different results from the outcomes of other pop­
ulations in which the pathology is not properly treated. However, it is
important to point out that auriculotherapy is a holistic technique that
focuses on treating individuals as a whole to promote balance and
restore health, and it is not focused on the pathologies. Furthermore, the
number of studies is limited and demonstrates methodological fragility
and incipiency of the experimental approach regarding this acupuncture
modality. There are no standardized protocols in the literature, espe­
cially regarding the subject in question. Therefore, the development of
studies with a longer therapy duration is suggested to better observe the
behavior of the variables.
Auricular acupuncture is recognized as a possible practice field that
is still under-explored and is highly relevant to nursing and clinical
practice. The preventive approach employed by the auricular
acupuncture has proved to be robust in the literature, graduated in some
variables that compose the vascular aspects and the temperature of the
lower limbs of people with DM2.
Moreover, the results of well-designed studies with a strong level of
evidence are necessary for the basis and development of Evidence-Based
Practice. Therefore, within the professional scope of nursing, this study
presents safe evidence for planning and considering the implementation
of acupuncture in professional practice.
5. Conclusion
Auricular acupuncture has proved to be effective in improving the
blood flow conditions and plantar temperature experienced by patients
with DM2 who participated in this study.
The proposed intervention kept the vascular conditions of the in­
dividuals participating in the study within a normal pattern, attributing
a preventive character to the treatment of Diabetic Foot. Likewise, the
reduced plantar temperature, as presented here and with an improve­
ment aspect, may contribute to the protection of the complication in
question.
Funding information
This work was supported by the Minas Gerais Research Support
Foundation (FAPEMIG) [grant number: APQ -02828 -16], by the Na­
tional Council of Technological and Scientific Development (Process No
443826/2018-8) and by the Coordenação de Aperfeiçoamento de Pes­
soal de Nível Superior - Brasil (CAPES) - Finance Code 001.
Clinical trial registration
Brazilian Registry of Clinical Trials, RBR-5n9934. Registered on Jan
09, 2018, http://www.ensaiosclinicos.gov.br/rg/RBR -RBR-5N9934/
Declaration of competing interest
No conflict of interest.
Acknowledgment
Postgraduate Program in Nursing of the Federal University of Alfenas
- UNIFAL-MG and Tutorial Education Program PET/MEC/SESU.
Appendix A. Supplementary data
Supplementary data to this article can be found online at https://doi.
org/10.1016/j.ctcp.2021.101442.
6
Complementary Therapies in Clinical Practice 44 (2021) 101442
References
[1] A.M. Mantovani, C.E. Fregonesi, M.R. Palma, F.E. Ribeiro, R.A. Fernandes, D.
G. Christofaro, Relationship between amputation and risk, Diabetes Metab Syndr
11 (1) (2017) 47–50, https://doi.org/10.1016/j.dsx.2016.08.002.
[2] N.K. Chammas, R.L. Hill, M.E. Edmonds, Increased mortality in diabetic foot ulcer
patients: the significance of ulcer type, J Diabetes Res 2016 (2016) 2879809,
https://doi.org/10.1155/2016/2879809.
[3] G.H. Skrepnek, J.L. Mills Sr., L.A. Lavery, D.G. Armstrong, Health care service and
outcomes among an estimated 6.7 million ambulatory care diabetic foot cases in
the U.S, Diabetes Care 40 (7) (2017) 936–942, https://doi.org/10.2337/dc16-
2189.
[4] S.A. Bus, J.J. Van Netten, A shift in priority in diabetic foot care and research: 75%
of foot ulcers are preventable, Diabetes Metab Res Rev 32 (Suppl. 1) (2016)
195–200, https://doi.org/10.1002/dmrr.2738.
[5] I. Dietrich, G.A. Braga, F.G. de Melo, A.C.C.C.S. Silva, The diabetic foot as a proxy
for cardiovascular events and mortality review, Curr. Atherosclerosis Rep. 19
(2017) 44, https://doi.org/10.1007/s11883-017-0680-z.
[6] G. Seghieri, L. Policardo, E. Gualdani, R. Anichini, P. Francesconi, Gender
difference in the risk for cardiovascular events or mortality of patients with
diabetic foot syndrome, Acta Diabetol. 6 (9) (2019) 561–567, https://doi.org/
10.1007/s00592-019-01292-y.
[7] S. Dyasnoor, S. Kamath, N. Khader, Effectiveness of electrostimulation on whole
salivary flow among patients with type 2 diabetes mellitus, Perm. J. 21 (2017)
15–164, https://doi.org/10.7812/TPP/15-164.
[8] N. Alqahtani, K.M. Oh, P. Kitsantas, M. Rodan, Nurses’ evidence-based practice
knowledge, attitudes and implementation: a cross-sectional study, J. Clin. Nurs. 29
(2020) 274–283, https://doi.org/10.1111/jocn.15097.
[9] Consort Consort, Checklist of information to include when reporting a randomised
trial, Retrieved from, http://www.consortstatement.org/consort-2010, 2010.
[10] Consort, The CONSORT flow diagram, Retrieved from, http://www.consort-state
ment.org/consort-statement/flow-diagram.
[11] M.M. Alshehri, A.S. Alqahtani, A.M. Alenazi, M. Aldhahi, S. Alothman, C. Gray,
B. Alqahtani, K. Khunti, P. Kluding, Associations between ankle-brachial index,
diabetes, and sleep apnea in the Hispanic community health study/study of Latinos
(HCHS/SOL) database, BMC Cardiovasc. Disord. 20 (1) (2020) 118, https://doi.
org/10.1186/s12872-020-01402-7.
[12] M.D. Gerhard-Herman, H.L. Gornik, C. Barrett, N.R. Barshes, M.A. Corriere, D.
E. Drachman, et al., AHA/ACC guideline on the management of patients with lower
extremity peripheral artery disease: executive summary. A report of the American
College of Cardiology/American Heart Association Task Force on Clinical Practice
Guidelines, Circulation. 2017 135 (12) (2016) 686–725, https://doi.org/10.1161/
CIR.0000000000000470.
[13] A. Aboyans, M.H. Criqui, P. Abraham, M.A. Allison, M.A. Creager, C. Dihem, et al.,
Treat-Jacobson, D. Measurement and interpretation of the ankle-brachial index,
Circulation 126 (24) (2012) 1–29, https://doi.org/10.1161/
CIR.0b013e318276fbcb.
[14] S.H. Ko, D.F. Bandykn, Interpretation and significance of ankle-brachial systolic
pressure index, Semin. Vasc. Surg. 26 (2–3) (2013) 86–94, https://doi.org/
10.1053/j.semvascsurg.2014.01.002.
[15] M. Bharara, J. Schoess, D.G. Armstrong, Coming events cast their shadows before:
detecting inflammation in the acute diabetic foot and the foot in remission,
Diabetes Metab Res Rev 28 (Suppl 1) (2012) 15–20, https://doi.org/10.1002/
dmrr.2231.
[16] N.C.M. Silva, H.A. Castro, L.C. Carvalho, É.C.L. Chaves, L.O. Ruela, D.H. Iunes,
Reliability of infrared thermography images in the analysis of the plantar surface
temperature in diabetes mellitus, J Chiropr Med 17 (1) (2018) 30–35, https://doi.
org/10.1016/j.jcm.2017.10.006.
[17] R. Mendes, N. Sousa, A. Almeida, J.V. Alves, Thermography: a technique for
assessing the risk of developing diabetic foot disorders, Postgrad. Med. 91 (1079)
(2015) 538, https://doi.org/10.1136/postgradmedj-2015-133441.
[18] H. Macpherson, D.G. Altman, R. Hammerschlag, L. Youping, W. Taixiang,
A. White, D. Moher, Revised Standards for reporting interventions in clinical trials
of acupuncture (STRICTA): extending the CONSORT statement, PLoS Med. 8;7 (6)
(2010), e1000261, https://doi.org/10.1371/journal.pmed.1000261.
[19] S. Wang, Z. Chen, P. Fu, L. Zang, L. Wang, X. Zhai, F. Gao, A. Huang, Y. Zhang, Use
of auricular acupressure to improve the quality of life in diabetic patients with
chronic kidney diseases: a prospective randomized controlled trial, Evid Based
Complement Alternat Med 2014 (2014) 1–12, https://doi.org/10.1155/2014/
343608, 343608.
[20] Liu CF, Yu LF, Lin CH, Lin SC. Effect of auricular pellet acupressure on
antioxidative systems in high-risk diabetes mellitus. J. Alternative Compl. Med.
2088; 14(3):303-307. doi: https://doi.org/10.1089/acm.2006.6064.
[21] F. Huang, J. Dong, J. Kong, H. Wang, H. Meng, R.B. Spaeth, S. Camhi, X. Liao, X. Li,
X. Zhai, S. Li, B. Zhu, P. Rong, Effect of transcutaneous auricular vagus nerve
stimulation on impaired glucose tolerance: a pilot randomized study, BMC Compl.
Alternative Med. 14 (2014) 203, https://doi.org/10.1186/1472-6882-14-203.
[22] H. Abboud, L.D. Tavares, J. Labreuche, A. Arauz, A. Bryer, P.M. Lavados, et al.,
Impact of low ankle-brachial index on the risk of recurrent vascular events, Stroke
50 (4) (2019) 853–858, https://doi.org/10.1161/STROKEAHA.118.022180.
[23] G. Hackl, A. Prenner, P. Jud, F. Hafner, P. Rief, G. Seinost, E. Pilger, M. Brodmann,
Auricular vagal nerve stimulation in peripheral arterial disease patients, Vasa 46
(6) (2017) 462–470, https://doi.org/10.1024/0301-1526/a000660.
[24] A. Bailey, D. Wingard, M. Allison, P. Summers, D. Calac, Acupuncture treatment of
diabetic peripheral neuropathy in an American Indian community, J Acupunct
Meridian Stud 10 (2) (2017) 90–95, https://doi.org/10.1016/j.jams.2016.10.004.
B. Bacelar de Assis et al.
[25] S.B. Leung, H. Zhang, C.W. Lau, Z.X. Lin, Attenuation of blood pressure in
spontaneously hypertensive rats by acupuncture was associated with reduction
oxidative stress and improvement from endothelial dysfunction, Chin. Med. 11 (1)
(2016) 38, https://doi.org/10.1186/s13020-016-0110-0.
[26] N. Manevska, S. Stojanoski, D. Gjorceva, L. Todorovska, M. Vavlukis, V. Majstorov,
Tissue-muscle perfusion assessed by one day 99m Tc-MIBI rest-dipyridamol
scintigraphy in non-diabetic and diabetic patients, Rev. Española Med. Nucl.
Imagen Mol. 37 (3) (2018) 141–145, https://doi.org/10.1016/j.
remn.2017.09.005.
[27] C.E.C. Almeida, Collagen implant with gentamicin sulphate as an option to treat a
neuroischaemic diabetic foot ulcer: case report, Int J Surg Case Rep 21 (2016)
48–51, https://doi.org/10.1016/j.ijscr.2016.02.023.
[28] C.F.J. Renero, The thermoregulation of healthy individuals, overweight-obese, and
diabetic from the plantar skin thermogram: a clue to predict the diabetic foot,
Diabet. Foot Ankle 8 (1) (2017) 1361298, https://doi.org/10.1080/
2000625X.2017.1361298.
[29] M. Lazo-Porras, A. Bernabe-Ortiz, K.A. Sacksteder, R.H. Gilman, G. Malaga, D.
G. Armstrong, J.J. Miranda, Implementation of foot thermometry plus mHealth to
prevent diabetic foot ulcers: study protocol for a randomized controlled trial, Trials
17 (1) (2017) 206, https://doi.org/10.1186/s13063-016-1333-1.
Complementary Therapies in Clinical Practice 44 (2021) 101442
[30] J.H. Yue, S.J. Zhang, Q. Sun, Z.R. Sun, X.X. Wang, B. Golianu, Y. Lu, Q. Zhang,
Local warming therapy for treating chronic wounds: a systematic review, Medicine
97 (12) (2018), e9931, https://doi.org/10.1097/MD.0000000000009931.
[31] S. Wang, D. Zhang, L. Tang, S. Li, M. Wen, X. Song, Effects of electroacupuncture
stimulation at “zusanli” acupoint on hepatic NO release and blood perfusion in
mice, Evid Based Complement Alternat Med 2015 (2015) 826805, https://doi.org/
10.1155/2015/826805.
[32] J.Y. Tan, A. Molassiotis, T. Wang, L.K.P. Suen, Adverse events of auricular therapy:
a systematic review, Evid Based Complement Alternat Med 2014 (2014) 506758,
https://doi.org/10.1155/2014/506758.
[33] C.S. Zhang, H.Y. Tan, G.S. Zhang, A.L. Zhang, C.C. Xue, Y.M. Xie, Placebo devices
as effective control methods in acupuncture clinical trials: a systematic review,
PloS One 10 (11) (2015), e0140825, https://doi.org/10.1371/journal.
pone.0140825.
[34] M.L. Neves, Acupuntura auricular e neuromodulação, Merithus Editora, Santa
Catarina, 2019.
[35] P. Nathenson, S.L. Nathenson, Complementary and alternative health practices in
the rehabilitation nursing, Rehabil. Nurs. 42 (1) (2017) 5–13, https://doi.org/
10.1002/rnj.227.