European Journal of Integrative Medicine 8 (2016) 122–127

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European Journal of Integrative Medicine

journal homepage: www.elsevier.com/eujim

Efficacy and safety of microcurrent stimulation of acupoints on the sole

of the foot of children with short stature in 25th percentile of height by
age: A randomized controlled trial$
Aram Junga , Jinhong Cheona , Ki-won Parkb , Jun-Yong Choic, Myeong Soo Leed,
Kibong Kima,*
a
Department of Korean Pediatrics, School of Korean Medicine, and Korean Medicine Hospital of Pusan National University, Yangsan, Republic of Korea
b
SJAY Medience Co. Ltd., Seoul, Republic of Korea
c
Department of Internal Medicine, Korean Medicine Hospital of Pusan National University, Yangsan, Republic of Korea
d
Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea

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

Article history: Introduction: This study aimed to evaluate the effect of the microcurrent stimulation of 4 plantar
Received 10 June 2015 acupoints (including KI-1) on the secretion of insulin-like growth factor (IGF)-1 and IGF binding protein 3
Received in revised form 3 September 2015 (IGFBP-3) in children with short stature in the bottom 25th percentile of height by age.
Accepted 3 September 2015
Methods: A total of 26 children (7–18 years old) with short stature were randomly divided into the
treatment group or the control group at the National Clinical Research Center for Korean Medicine. For 6
Keywords: weeks, the treatment group wore the microcurrent stimulator while asleep, while the control group did
Randomized controlled trial
not receive the treatment. The device worked for 5 h during sleep, and the actual stimulation time was
Microcurrent
Acupoint
1 h. The 4 acupoints on the foot related to growth, including KI-1 (Yongcheon), were stimulated with a
IGF-1 1 Hz, 32–35 mA microcurrent. The primary endpoints were the changes in IGF-1 and IGFBP-3 from
IGFBP-3 baseline to the 6th week.
Short stature Results: In the treatment group, the mean of the change in IGF-1 showed a statistically significant
difference. The change between pre- and post-trial in the treatment group was more prominent than in
the control group. There were no significant differences in IGF-BP3 in either group.
Conclusion: The microcurrent stimulation of the acupoints may have an effect that promotes growth in
short-stature children by increasing IGF-1. Further studies are warranted.
ã 2015 Elsevier GmbH. All rights reserved.

1. Introduction Furthermore, it heals wounds or increases tissue activity with

Microcurrent therapy has been used to treat various diseases
such as arthritis, tuberculosis, pneumonia, as well as in wound
healing and psychotherapy [1]. Furthermore, it has been applied to
diverse pains and nervous, musculoskeletal, and skin diseases
[1–3].
Microcurrent treatment in Western and Korean medicine
corresponds to a range of physiological currents in the body [1].
Thus, it has been found that microcurrent does not cause muscle
contraction and therefore does not cause discomfort [4].
$
This article belong to the Special Issue on Paediatric integrative medicine.
* Corresponding author at: Department of Korean Pediatrics, Korean, Medicine
hospital, National Clinical Research Center for Korean Medicine, Pusan National,
University, Geumo-ro 20, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do 626-789,
Republic of Korea. Fax: +82 55 360 5952.
E-mail address: kkb@pusan.ac.kr (K. Kim).
only a small amount of current.
Microcurrents regulate the secretion of cytokines in the body
[5]. As a result, microcurrent therapy is involved in the
development of fibrosis or scar tissue, the deposition of minerals,
the secretion of histamines, and the regulation of inflammation. In
addition, microcurrent increases the secretion of b-endorphin.
b-endorphin has been found to affect the secretion of growth
hormone (GH) by growth-hormone-releasing hormone (GHRH) in
preadolescent children. According to a previous study of micro-
current therapy, levels of GH were increased as a result of a
combination therapy with microcurrent shoes and exercise in
adolescents [6]. These results suggest that microcurrent could
possibly promote GH secretion in children and may be a good
method for promoting growth in children [7].
GH treatment is generally used to promote growth [8].
However, treatment should continue until the end of growth. It
is recommended that treatment should start early, before 5 years

http://dx.doi.org/10.1016/j.eujim.2015.09.002
1876-3820/ ã 2015 Elsevier GmbH. All rights reserved.
 A. Jung et al. / European Journal of Integrative Medicine 8 (2016) 122–127
of age, as the potential for growth greatly declines if the
treatment starts after 10 years of age. GH treatment has been
known to be relatively safe, but there is a report indicating that
the treatment causes sleep apnoea by stimulating lymphoid
tissue enlargement [9]. Thus, it is not advised for patients with
severe obesity or sleep apnoea. Furthermore, the recovery of
psychological satisfaction, which is anticipated from growth
hormone treatment, is not remarkable, especially given the high
cost [8]. Receiving a shot almost every day is also a heavy mental
burden to children [8]. Because of the limitations of GH therapy,
there is an increasing demand for an effective, safe, and easy-to-
use treatment [10,11].
In Korean medicine, acupoints on the sole of the foot are
generally known to stimulate growth. Korean medicine also
considers that acupoints on the sole of the foot stimulate serotonin
secretion via stimulation of the kidney and adrenal gland.
According to a previous study, increased serotonin secretion
induced by stimulating acupoints on the sole of the foot influence
growth hormone secretion [12].
A prior study reported that there was no safety issue for infants
with congenital muscular torticollis using the device 3 times per
week for 2 weeks [13]. Rhim and Kim tested the effect of the
microcurrent stimulation of points related with growth on the
serum GH concentration during exercise in ten 5th grade
elementary school students [6]. However, they reported on the
combined therapy of exercise and microcurrent, and exercise is a
factor that has a great influence on growth by itself. Thus, the
results could be considered to be a result of the effect of exercise,
and an additional study on microcurrent alone is necessary. The
purpose of this study was to identify the neurohormonal effects of
microcurrent treatment on the sole of the foot in children with
short stature in the bottom 25th percentile of height by age.
2. Methods
2.1. Participants
This study was conducted at the National Clinical Research
Center for Korean Medicine in the Korean Medicine Hospital of
Pusan National University. The participants were recruited from
September 13th, 2014 to December 26th, 2014. The children with
short stature in the bottom 25th percentile of height by age were
suitable, according to the inclusion criteria.
2.2. Ethics
This study protocol was approved by the Korean Food and Drug
Administration (KFDA) (protocol registration number: 641). We
conducted this study based on the Declaration of Helsinki. This
study was approved by the Institutional Review Board (IRB) of
Pusan National University Korean Medicine Hospital (PNUKH),
Yangsan, South Korea (approval No.: 2014003).
2.3. Inclusion and exclusion criteria
We included participants who fulfilled all of the following
criteria: (1) healthy children and adolescents between 7 and 18
years old whose stature was in the bottom 25% of the percentile by
sex and age in the ‘2007 Korean Children and Adolescents Growth
Standard [14]’ but did not have endocrine diseases, metabolic
diseases, or nutritional deficiency causing short stature; (2)
voluntary participation, signed written consent, and signed the
written consent by the parents.
Two authors (Kim K.B. and Jung A.) evaluated the eligibility of
the participants in accordance with the inclusion criteria. The two
authors checked vital signs, blood, and performed a physical
123
examination of participants on the first visit. Subsequently, the
authors excluded unsuitable participants on the basis of test
results. We excluded participants who had any of the following: (1)
underlying diseases that can cause hormonal imbalance, such as
pituitary adenoma; (2) inability to wear the medical device for the
clinical trial because he/she had sensitive skin or because of other
reasons; (3) required aggressive treatments because he/she had
severe physical or mental diseases; (4) had received a medical or
Korean medical treatment related to the symptoms, as mentioned
above; and (5) other cases that the investigator deemed
inappropriate.
2.4. Study procedure
This study was a prospective randomized controlled trial. Prior
to starting this clinical trial, the investigator obtained each
subject’s baseline characteristics and medical history in an
interview and recorded them on the case report form. The baseline
characteristics included demographic information (name, age,
height, weight, gender, and contact information), vital signs (blood
pressure and pulse rate), past history, history of present illness,
physical examination, basic blood test, assessment of height
percentile by age, and bone age.
A basic blood test was conducted not as the primary endpoint
for growth but to check the health of the subjects. The complete
blood count measured the following components via a basic blood
test: differential (CBC and DC), blood glucose, Na+, K+, Cl , ferritin,
liver function test (AST and ALT), and C-reactive protein (CRP). We
also identified hormones levels, including that of GH. We chose
hormones that directly affected growth as the primary endpoints.
Studies involving children should investigate all potential risks
including factors that are generally not considered in adult studies;
these factors include the effect of growth [8]. The investigator then
performed a thorough medical history to screen subjects for the
inclusion criteria. During the trial, a compliance assessment was
performed. Before starting the trial, we offered a questionnaire
assessing compliance. To increase compliance, investigators made
a weekly phone call to the subjects or their guardians and checked
on progress. When the subjects visited after 6 weeks, the
investigator assessed the compliance, which was checked via
pamphlet.
Based on previous studies using microcurrent, we anticipated
that there would be few adverse events. However, we anticipated
allergic reactions such as contact dermatitis, hives, and pruritus on
the electrode-contacting area and pain or paraesthesia on the area
where the device was worn.
Via phone call, the investigator checked for adverse events at
the 2nd and the 4th weeks during the 6 weeks of the study period.
We frequently reminded the subjects to voluntarily report adverse
events. We also checked for adverse events when the subjects
visited at the 6th week.
2.5. Intervention
This study used a plantar-reflective microcurrent stimulator
(Dr. Park’s Growth Pad, SJay Medience Co., Ltd., South Korea) for 6
weeks. The shape of the device is the same as that illustrated in
Fig. 1. It was used during sleep and consistently stimulated specific
areas of the foot with a microcurrent that flows with a specified
waveform at a specified time. This device was developed for the
easy, consistent, and efficient administration of a 1 Hz, 32–35 mA
microcurrent that humans cannot feel. The actual stimulation time
was 1 h during a 5 h period. The microcurrent was emitted 3 times
for 20 min at a time. The 4 acupoints related with growth were as
follows: (1) KI-1 (Yongcheon), (2) the area connecting the sole and
the largest toe, (3) the area connecting the sole and the little toe (at
124 A. Jung et al. / European Journal of Integrative Medicine 8 (2016) 122–127
Fig. 1. The shape of a plantar-reflective microcurrent stimulator (Dr. Park’s Growth
Pad).
the same height as the former), and (4) the plantar side of the
largest toe. The stimulated acupoints are marked in Fig. 2.
The subjects were taught to wear a pair of devices on both feet.
Although the duration of wearing the device was not indicated, the
subjects were informed to wear the device for at least 6 h during
sleeping hours.
2.6. Outcomes
The primary endpoints were the change in levels of insulin-like
growth factor 1 (IGF-1) and IGF binding protein 3 (IGFBP-3) from
baseline to the 6th week. The measurement of the levels IGF-1 and
IGFBP-3 is a typical method that measures GH deficiency in
children, with a direct correlation to short stature [15].
The secondary endpoint was the change in the standard
deviation (SD) of height-for-age (H/A), height, weight, and height
percentile by age from baseline to the 6th week as well as adverse
events. Per the growth chart, the assessment of growth is based on
how far from the normal range growth deviates by statistical
distribution; this is what the SD of H/A indicates. Thus, it was
important to calculate the SD in order to quantitatively grasp the
level of growth.
2.7. Sample size
A total of 26 children were recruited. Thirteen subjects were in
the control group, and 13 subjects were in the treatment group.
This clinical trial was a pilot study that assessed the feasibility of a
clinical trial to verify the safety and efficacy of a plantar-reflective
microcurrent stimulator and to calculate the number of samples
required for a large-scale study in the future. Because this study
was a pilot study conducted when the basic data were lacking, we
did not calculate the number of subjects with a suitable statistical
method; this study was performed with the minimum number of
subjects assigned to each group (13 subjects). From the results of
this study, we calculated the number of samples required to obtain
an appropriate power, and we will conduct a large-scale clinical
trial in the future. Although this was a pilot study, we conducted
statistical analysis for basic validation in accordance with the
validation method.
2.8. Randomization, allocation concealment, implementation and
blinding
The subjects who fulfilled the inclusion and exclusion criteria
ware randomly allocated to the treatment group and the control
group. Randomization was performed by SAS 9.3 (SAS Institute
Fig. 2. The 4 plantar acupoints stimulated by the device: (1) KI-1 (Yongcheon), (2)
the area connecting the sole and the largest toe, (3) the area connecting the sole and
the little toe (at the same height as the former), and (4) the plantar side of the
largest toe.
Inc., 2012, Cary, NC, USA) with a block size of 4. We used allocation
concealment. A third-party assistant not involved in this study
enclosed the random list generated by a random computerized
method in an opaque sealed envelope. We also blinded the
outcome assessors in order to minimize errors that could be
interposed. The investigator who did not participate in subject
screening and randomization took part in the assessment
processes, including the assessments of height measurement,
blood testing, and urinalysis. This study used an untreated control
group. Because it was difficult to blind the subjects, we had no
choice but to conduct this study as an open-label study. The
efficacy endpoints were measured by objective indicators so that
the possibility for investigator or subject bias was reduced, which
is possible in an open-label clinical trial.
2.9. Statistical analysis
The efficacy and the safety evaluation were based on the
analysed result of intention-to-treat analysis. Missing values were
replaced by the last observation carried forward (LOCF) method.
Because missing values did not occur in this study, values obtained
from all subjects were included in the result. The statistical
significance was set at 5%. When analysing the efficacy endpoints,
if missing values occurred after baseline in the analysis groups or
the subjects dropped out before finishing the clinical trial, we
analysed the data using the available dataset without replacement.
The baseline characteristics of the participants were analysed
by Fisher’s exact test and an unpaired t-test (Table 1). The efficacy
endpoints such as IGF-1 (ng/mL), IGFBP-3 (ng/mL), height (cm),
weight (kg), height percentile by age (%), and SD score for H/A (cm)
were organized and summarized using descriptive statistics
(median, mean, SD, minimum, and maximum) for each group.
Furthermore, we analysed the data by performing an analysis of
covariance (ANCOVA); the change of the score between the control
group and the treatment group was the dependent variable, the
baseline score was the covariate, and the two groups were the fixed
factors. We analysed the differences of each endpoint before and
after the treatment and presented a 95% confidence interval (CI).
 A. Jung et al. / European Journal of Integrative Medicine 8 (2016) 122–127 125

Table 1
Baseline characteristics of the participants.

Control (n = 13) Treatment (n = 13) P valuea

Sex
Male (n) 4 8 .24b
Female (n) 9 5
Age (yr, mean) 9.85  2.58 9.39  2.18 .63
Height (cm) 131.98  13.28 130.62  12.33 .79
Weight (kg) 31.15  10.27 27.46  9.26 .35
Height percentile by age (%) 16.15  6.31 14.38  6.32 .48
Index for height standard deviation (cm) 544.53  53.51 518.44  34.82 .15
IGF-1 (ng/mL) 203.22  108.6 193.67  88.72 .81
IGFBP-3 (ng/mL) 3733.08  976.24 3875.38  625.41 .66

The data are expressed as the mean  SD for the control and treatment group baseline characteristics and the mean and 95% CI for the differences in the groups. *P < 0.05; **
P < 0.001 compared with control treatment.
a
Independent two sample t-test unless indicated otherwise.
b
Fisher’s exact test.

We also performed the repeated measures analysis of variance 3. Results

(ANOVA) to test the difference in tendency change between the
two groups at each visit.
All expressed adverse events are listed with detailed explan-
ations. We recorded the frequencies of the adverse events
associated with or without the treatment. We performed Fisher’s
exact test to determine whether there was a difference in the
incidence of adverse events reported by the subjects between the
control group and the treatment group. Then, we performed
descriptive analysis to evaluate the severity and type of adverse
events in each group. We also performed a suitable statistical
analysis to analyse other variables.
We screened 29 children for eligibility and excluded 3 children.
Twenty-six eligible participants were randomized into the
treatment group (n = 13) or no-treatment group (n = 13). All
participants finished the 6-week period and data were analysed
(Fig. 3).
There were no significant differences between the two groups
in gender, age, height, Index of height standard deviation, IGF-I and
IGF-BP3 (Table 1).
After correcting for the baselines of the primary and the
secondary endpoints, the mean comparison of endpoints between
the two groups was not statistically significant (Table 2).

Fig. 3. Trial flow diagram in this study.

126 A. Jung et al. / European Journal of Integrative Medicine 8 (2016) 122–127

Table 2
Mean comparison between the two groups for pre, post and difference of change in the outcomes.

Variables Control (n = 13) Treatment (n = 13)

Pre Post Diff (post–pre) Pre Post Diff (post–pre)

IGF-1 (ng/mL) 203.22  108.6 217.82  106.76
14.6  45.47 193.67  88.72 221.62  83.06
27.95  44.05
14.60( 12.88,42.08) 27.95(1.33,54.57)*
IGFBP-3 (ng/mL) 3733.08  976.24 3902.31  853.02 169.23  793.88 3875.38  625.41 4141.54  785.3 266.15  638.29
169.23 266.15
( 310.50,648.97) ( 119.56,651.87)
Height (cm) 131.98  13.28 132.98  13.16 1.00  0.70 130.62  12.33 131.72  12.25 1.10  0.90
1.00(0.58,1.42)** 1.1(0.56,1.64)**
Weight (kg) 31.15  10.27 32  10.59 0.85  1.57 27.46  9.26 28.23  9.77 0.77  2.52
0.85( 0.10,1.80) 0.77( 0.75,2.29)
Height percentile by age (%) 16.15  6.31 17.69  8.24 1.54  3.38 14.38  6.32 15.38  7.67 1.00  4.10
1.54( 0.51,3.58) 1.00( 1.48,3.48)
Index for height standard deviation (cm) 544.53  53.51 543.61  54.16 0.92  6.36 518.44  34.82 516.85  31.95 1.59  7.19
0.92(-4.77,2.92) 1.59( 5.94,2.75)

The data are expressed as the mean  SD for pre and post primary outcomes and the mean and 95% CI for the difference in change.
*
P < 0.05.
**
P < 0.001 compared with pre-intervention. ANCOVA was used for statistical analysis.

The mean difference in the primary endpoints, i.e., the changes
in IGF-1 and IGFBP-3 levels before and after the trial (post–pre)
between the two groups, were not statistically significant.
However, for the IGF-1 level, the 95% CI for the mean of the
change was 1.33 ng/mL, 54.57 ng/mL. In the treatment group, the
mean of the change of the IGF-1 level in the treatment group
showed a statistically significant difference compared with that at
pre-treatment (Table 2). The change between pre- and post-trial
tended to increase more in the treatment group than in the control
group.
The mean differences in the changes of the secondary endpoints
(height, weight, height percentile by age, and SD score for H/A)
before and after the trial (pre and post) between the two groups
were not statistically significant. However, for height, the change
difference was statistically significant for each group (Table 2).
In the safety assessment, there were no reported adverse events
directly related to this clinical trial. Although one case of enuresis
was reported, we determined that it was irrelevant to the device.
The subject had had enuresis before wearing the device, and there
was no particular difference in symptoms after wearing the device.
Thus, the case of enuresis was irrelevant to the device.
4. Discussion
This preliminary randomized controlled trial was conducted to
investigate the effects of the microcurrent stimulation of plantar
acupoints on IGF-1 and IGFBP-3 secretion in children with short
stature in the bottom 25th percentile of height before and after
treatment. Furthermore, the change between pre- and post-trial
was increased more in the treatment group than in the control
group. From the results of the secondary endpoints, we were able
to identify that there was a difference in average height pre- and
post-trial, but no difference between the two groups was detected
by ANCOVA analysis. Furthermore, we were not able to identify
whether the difference was an effect of the treatment or due to a
natural change. There was no difference between the two groups in
height. Because this study was conducted for the short time of 6
weeks, it was not able to exactly distinguish the the difference in
height change between the groups
From our results, although there was no statistically significant
difference between the two groups in terms of IGF-1 and IGFBP-3
levels, the mean of the change in IGF-1 in the treatment group
showed a statistically significant difference compared with pre-
treatment.
According to the two previous studies that reported that the
microcurrent stimulation of acupoints stimulated GH secretion in
elementary and middle school students, the group that exercised
with the functional shoes that stimulated growth points on the
foot with microcurrent showed significantly higher GH secretion
than the control group that did not wear the functional shoes [6,7].
Thus, the proper use of microcurrent can be used to increase GH
secretion. Additionally, there were previous studies demonstrating
that microcurrent aids the growth and damage recovery of muscle,
the recovery of hyaline cartilage, the recovery of ligament damage,
and the growth and damage recovery of osseous tissues; micro-
current is related to the growth of the body via these mechanisms
[16–18]. Based on these previous studies, we anticipated that
microcurrent would increase GH secretion, as it is involved in the
formation of soft tissues and osseous tissues of the body and
ultimately in growth.
In the safety assessment, there were no adverse events reported
that were directly related to this clinical trial. Although there was 1
case of enuresis, we determined that it was irrelevant to the device.
This was because the subject had had enuresis before wearing the
device, and there was no particular difference in symptoms after
wearing the device.
In conclusion, the effect of the microcurrent stimulation of
acupoints in increasing GH levels in children with short stature in
the bottom 25th percentile of height by age is positive for IGF-1 and
IGFBP-3 compared with pre-treatment. Therefore, further large
sample randomized clinical trials should be carried out with at
least 6 months of follow-up.
Conflict of interest
None.
Acknowledgment
Kibong Kim was supported by a 2-Year Research Grant of Pusan
National University, Busan, Republic of Korea.
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