Journal of Acupuncture and Meridian Studies 2023;16(2):79-87

pISSN 2005-2901 • eISSN 2093-8152

https://doi.org/10.51507/j.jams.2023.16.2.79 CLINICAL STUDY PROTOCOL

Effectiveness and Safety of Adjunctive

Pharmacopuncture to Acupuncture Treatment for
Rotator Cuff Diseases: a Protocol for an Assessor-Blinded,
Pragmatic Randomized Controlled, Pilot Trial
Hyun Ji Cha1,†, Chang-Hyun Han2,3,†, Ju Hyun Jeon1, Jeong Kyo Jeong1, Hong Kyoung Kim1, Changsop Yang2,
Byoung-Kab Kang2, Min Ji Kim4, Young Eun Choi4, In-Hyuk Ha5, Young Il Kim1,*
1
Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daejeon University, Daejeon, Korea
2
Korean Medicine Research Division, Korea Institute of Oriental Medicine, Daejeon, Korea
3
Korean Convergence Medicine, University of Science & Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon, Korea
4
Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon, Korea
5
Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Korea

Received February 16, 2023 Background: Shoulder pain is a common musculoskeletal disorder. Treatment can be
Revised March 9, 2023 surgical or non-surgical. Korean Medicine, including acupuncture and pharmacopuncture,
Accepted March 25, 2023 is a part of conservative treatment. Pharmacopuncture, combining acupuncture with
herbal medicine, has been used for musculoskeletal disorders since the 1960s, but clinical
evidence on its effectiveness is lacking.
Objectives: This study aims to assess the effectiveness and safety of pharmacopuncture
for rotator cuff disease.
Methods: A two-group, parallel, single-center, pragmatic, randomized, controlled,
assessor-blinded trial will be conducted. A total of 40 patients will be recruited, starting in
July 2022. All patients will be received acupuncture treatment, and pharmacopuncture will
be applied to intervention group additionally. After eight treatments are delivered over four
weeks, follow-up assessments will be performed.
Results: Assessments will evaluate the effectiveness and safety of these treatments at
baseline and at weeks 2 (2 W), 4 (4 W), and 8 (8 W). The primary outcome will be a visual
analog scale (VAS) evaluation of shoulder pain levels. Assessments will include shoulder
pain and disability index (SPADI), shoulder range of motion (ROM), EuroQol 5-Dimension
5-Level (EQ-5D-5L), patient global impression of change (PGIC), ‘no worse than mild
pain’, and drug consumption rates.
Correspondence to Conclusion: This study may offer a rationale for a future full-scale trial on the effective­
Young Il Kim ness and safety of pharmacopuncture treatment for rotator cuff disease and provide data
Department of Acupuncture & on non-surgical treatment for the disease.
Moxibustion Medicine, College of
Korean Medicine, Daejeon University, Keywords: Rotator cuff disease, Pharmacopuncture, Non-surgical intervention,
Daejeon, Korea Pragmatic, Protocol, Korean Medicine
E-mail omdkim01@dju.kr
†
The first two authors contributed Trial registration: Clinical Research Information Service and International Clinical Trials
equally to this study. Registry Platform of the World Health Organization (identifier, KCT0007416).

INTRODUCTION however, it is associated with substantial morbidity [6].

Shoulder pain is a common musculoskeletal complaint
in primary care, following lumbar and knee pain [1], affec­
ting approximately 18-26% of adults at any point in life [2-
5]. A painful shoulder is not associated with mortality;
In addition, symptoms affect an individual’s ability to
perform daily activities both at home and in the workplace
[7,8]. Consequently, managing shoulder pain consumes a
significant proportion of medical resources [9,10].
Shoulder disorders may involve impingement, shoulder

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muscle rupture, and calcific tendinitis; however, the terms
describing rotator cuff disorder associated with shoulder pain
are not standardized [11]. The term 'rotator cuff disease' has
been used to describe rotator cuff disorder at any anatomical
location and due to any cause [12,13].
Treatment of rotator cuff disease is divided into surgical
and conservative types. Surgery should be considered only
after conservative therapy has failed [14]. Some evidence
suggests that pain- and disability-related outcomes of surgical
and non-surgical treatments are comparable [1].
Korean Medicine offers conservative treatments, including
acupuncture and pharmacopuncture. Acupuncture may
reduce shoulder pain [15,16] even in chronic pain cases [17].
In fact, acupuncture can offer immediate pain relief and
improve shoulder function in adhesive capsulitis [18].
Pharmacopuncture combines acupuncture with herbal
medicine [19]. First introduced to Korea in 1960s, it is
frequently used in Korean Medicine [20,21]. Research
on pharmacopuncture began in the 1990s, with rando­
mized controlled trials (RCTs) launched in the 2000s.
Pharmacopuncture has been used for musculoskeletal,
neurological, and circulatory disorders, among others;
musculoskeletal disorders are the most common indication
[19,22]. Pharmacopuncture may involve bee venom,
Hominis placenta, and Aconitum ciliare Decaisne solutions
[23,24]. A study on pharmacopuncture for musculoskeletal
diseases in South Korea found that 32,947 (98.6%) of
33,145 inpatients at 12 Korean Medicine hospitals and
clinics received pharmacopuncture treatment, and 289,860
(77.6%) of 373,755 outpatients received pharmacopuncture
treatment. In addition, 6,710 outpatients presented with
shoulder-related diseases, which is the leading indication
for pharmacopuncture [25]. Pharmacopuncture alone
and in combination with acupuncture is more effective
at reducing pain and improving the quality of life than
acupuncture monotherapy or other conservative treatments
[26]. In addition, among 29 randomized controlled trials on
pharmacopuncture, five studies reported side effects that
included local pain, fatigue, and redness, which disappeared
in a short period of time without any additional treatment [27].
Pharmacopuncture is relatively safe and is unlikely to cause
serious adverse effects.
However, despite its widespread use, clinical evidence
on the safety and effectiveness of pharmacopuncture for
rotator cuff disease is lacking. To date, few studies have
compared pharmacopuncture with acupuncture, which
is another treatment of Korean Medicine. Therefore, this
pilot study aimed to evaluate the effectiveness and safety of
pharmacopuncture combined with acupuncture for rotator
cuff disease.
80 www.journal-jams.org
Hyun Ji Cha, et al.
MATERIALS AND METHODS
1. Objective
This study focuses on patients with rotator cuff disease.
The aims of this study are as follows:
1) To confirm the difference in pain levels, functional
outcomes, and consumed medicine dose between the
intervention group receiving pharmacopuncture therapy and
acupuncture treatment, and the control group receiving only
acupuncture treatment.
2) To compare the rates of adverse events between the
groups.
This is a practical clinical study that is not aimed to
determine the details of pharmacopuncture therapy or
acupuncture treatment. The treatment details will be
determined for each session. All matters regarding the
procedure will be recorded on case report forms (CRFs) and
reviewed retrospectively.
2. Study design
This study is a two-group, parallel, single-center, pragmatic,
randomized controlled, assessor-blinded trial. A total of 40
patients will be recruited based on the eligibility criteria from
among the patients presenting at Daejeon University Daejeon
Korean Medicine Hospital between July and December 2022.
Prospective participants will be asked to provide written
informed consent to participate in the trial. Study eligibility
will be determined based on demographic and clinical
characteristics, including medical history, questionnaire-
based assessments, shoulder radiographic examinations,
physical examinations, blood tests, electrocardiogram (ECG)
examinations, and urine human chorionic gonadotropin
levels for women that may be pregnant. Eligible participants
will be randomized to the acupuncture-pharmacopuncture
combination therapy group or acupuncture monotherapy
group at a 1:1 ratio. As a pragmatic trial, this study does not
prospectively prescribe treatment, which is at the discretion of
the Korean Medicine doctor and subject to patient symptoms.
The participants will complete a total of nine hospital visits,
including eight treatment sessions (twice per week for 4
weeks). Outcome assessments will be performed at weeks two,
four, and eight. Table 1 shows schedule of this clinical trial.
3. Inclusion criteria [28,29]
1) Age range of 19-75 years, both sexes.
2) Diagnosis of rotator cuff disease made by the study
principal investigator or another specialist prior to study
enrolment.
3) Visual Analogue Scale (VAS) shoulder pain score of ≥ 40
points.
4) Capacity and willingness to provide informed consent.
Pharmacopuncture for Rotator Cuff Disease

Table 1. Schedule for the treatment and the outcome measurements

Study Period
Follow-up Unsche­
Enrollment Treatment phase
phase duled visit
Visit Screening 1 2 3 4 5 6 7 8 9 -
Week 0 1 2 3 4 8 -
Enrollment
Informed consent ●
Inclusion/Exclusion criteria ●
Vital signs ● ● ● ● ● ● ● ● ● ● ●
Demographic characteristics ●
Medical history ●
Physical examination ● ●
Clinical laboratory test ● ● ●
Electrocardiography ●
Radiography of shoulder ●
Random allocation ●
Intervention
Intervention group: acupuncture- ◉ ◉ ◉ ◉ ◉ ◉ ◉ ◉
pharmacopuncture combination
therapy
Control group: acupuncture ○ ○ ○ ○ ○ ○ ○ ○
monotherapy
Assessments
VAS ● ● ● ● ●
SPADI ● ● ● ●
ROM ● ● ● ● ●
EQ-5D ● ● ● ●
PGIC ● ● ●
No worse than mild pain ● ● ●
Drug consumption ● ● ●
Change of medical history ● ● ● ● ● ● ● ● ● ●
Check withdrawal and dropout ● ● ● ● ● ● ● ● ● ●
Safety assessment ● ● ● ● ● ● ● ● ● ●
Visit schedule training ● ● ● ● ● ● ● ● ● ● ●

4. Exclusion criteria among others.

1) Shoulder surgery within the previous 3 months [30].
2) Diagnosis of malignancy or fracture, among others,
which may account for shoulder pain.
3) Anticipating shoulder surgery within the study period.
4) Underlying diseases (stroke, myocardial infarction,
kidney disease, severe diabetes, dementia, epilepsy, severe
hemorrhagic disease, etc.) that may interfere with the treat­
ment effect or result interpretation.
5) Treatment with steroids, immunosuppressants, psycho­
tropic medication, or any other drug that may affect outcomes
within the previous 3 months.
6) Severe abnormalities in blood test results, such as
aspartate aminotransferase (AST) or alanine transferase
(ALT) levels three-times the upper normal range limit, or
blood creatinine level twice the upper normal range limit,
7) Treatment with nonsteroidal anti- inflammatory drugs
(NSAIDs) or pharmacopuncture, acupuncture, physical
therapy within 1 week [31].
8) Present or planned pregnancy, and lactation.
9) Active or planned participation in another clinical trial
within 1 month or during the follow-up period, respectively.
10) Unsuitability for the trial, as judged by the principal
investigator.
5. Sample size
This is a preliminary pilot study designed to assess
the feasibility of a larger study. The sample included the
minimum number of participants required to evaluate the
treatment effectiveness. The sample size is based on similar
pilot studies [31,32] rather than on statistical calculations.

www.journal-jams.org 81

Therefore, the number of subjects was set to 20 per group for
a total a 40.
6. Randomization and allocation concealment
Randomization helps eliminate assessment bias in both
participants and assessors. A statistician not involved in
the study is responsible for participant randomization
using a random number table created using SAS® Version
9.4 (SAS Institute. Inc., Cary, NC). The randomization
results are delivered to the investigators in sealed opaque
envelopes, which are then stored in a double-locked cabinet.
All participants will be informed about the study aims and
procedures before signing a consent form. After baseline
assessments, an investigator will open a randomization
envelope. The investigator will write the day and time of
opening on the envelope and sign it before entering group
allocation into the participant’s electronic record.
7. Blinding
The characteristics of the treatments used in this study
precluded participant and administrator blinding; however,
study assessors are blinded to group allocation and are not
involved in the intervention. All evaluations and analyses will
be performed at a site different from the treatment site.
8. Intervention group: acupuncture-
pharmacopuncture combination therapy
Acupuncture-pharmacopuncture combination therapy will
be performed eight times in total, twice weekly for 4 weeks as
standard; it may be performed 1-3 times per week, as required.
A licensed Korean Medicine doctor, with at least two years of
clinical experience in acupuncture and pharmacopuncture,
will conduct the therapy, interacting with the participants as
normal, which is characteristic of a pragmatic clinical trial.
The treatment protocol is not pre-determined and will be
determined at the specialist’s discretion, depending on patient
presentation and changes over time. The intervention details
will be reported in the CRFs and reviewed retrospectively.
9. Control group: acupuncture monotherapy
Acupuncture monotherapy involves dry needling without
additional intervention. The course involves eight treatments,
delivered twice a week for 4 weeks in general; this treatment
may be delivered 1-3 times a week, as required. A licensed
Korean Medicine doctor, with at least two years of clinical
experience in acupuncture, will deliver all treatments and will
interact with the patient as normal, which is characteristic of a
pragmatic clinical trial. The acupuncture protocol is not pre-
determined, and the treatment remains at the administrators’
discretion, depending on patient symptoms and changes over
time. The intervention details will be recorded in the CRFs
82 www.journal-jams.org
Hyun Ji Cha, et al.
and reviewed retrospectively.
10. Co-interventions
All participants may receive other treatments for shoulder
pain relief at other treatment centers in cases of severe pain
onset during the study, including physical and exercise
therapy. Invasive treatments, including medication and
surgery, are not permitted during the trial. Finally, the partici­
pants may not undergo any other Korean medical treatments
for shoulder pain during the study period.
Acetaminophen with a maximum dose of ≤ 4,000 mg (8T/
day) [33,34] per day is provided as a rescue drug at visits 1, 4,
and 8, in cases of intolerable pain; drug consumption must be
reported. Intervention assessments will be performed without
the drug administration on assessment days 4, 8, and 9.
At every visit, the type and frequency of treatments
received elsewhere will be recorded on the CRFs. In cases
where treatments taken by the participants may interfere with
the study, these participants may be excluded.
Assessments of treatment safety and effectiveness will be
performed at baseline and weeks 2, 4, and 8.
11. Primary outcome: VAS shoulder pain score
The VAS score helps to evaluate pain levels. Subjects mark
the point representing their pain level on a straight 100-
mm line, which represents a range from “no pain at all” to
“maximum imaginable pain”. VAS scores will be the primary
outcomes in the study [35].
12. Shoulder pain and disability index (SPADI)
The SPADI helps estimate shoulder pain and dysfunction
caused by musculoskeletal pathology. It involves a pain and
disability subscale of five and eight items, respectively. A score
of 0 points indicates ‘best’ and 100 points indicates ‘worst’
outcomes. It uses an average of 13 subscale items with higher
scores indicating a greater degree of disability [36].
13. Shoulder motion range
The active range of motion represents shoulder function.
An assessor measures the angle of f lexion, extension,
abduction, external rotation, and internal rotation using a
goniometer, considering spinal movement [37,38].
14. EuroQol 5-Dimension 5-Level (EQ-5D-5L)
The EQ-5D-5L is an instrument for measuring the quality
of life using five levels of severity across five dimensions. Each
dimension has five response categories corresponding to
absent, slight, moderate, severe, and extreme problems. The
vertical VAS score helps evaluate overall health on the day of
assessment on a vertical line marked from 0-100 points [39].
Pharmacopuncture for Rotator Cuff Disease
15. Patient Global Impression of Change (PGIC)
The PGIC score reflects treatment efficacy by evaluating
changes in pain levels as ‘very much improved’, ‘much
improved’, ‘minimally improved’, ‘no change’, ‘minimally
worse’, ‘much worse’, or ‘very much worse’ relative to baseline
values [40].
16. ‘No worse than mild pain’
Reducing pain to levels of ‘no worse than mild pain’ has
economic and health benefits. Although treating pain is
challenging, maintain the levels mild and below may be
considered effective pain control [41].
17. Drug consumption
Acetaminophen is provided to participants experiencing
uncontrolled severe shoulder pain during the study period.
The consumption of the drugs reflects the analgesic effects
of the intervention. Participants will be required to complete
a dosing diary and bring the remaining drug amounts to the
assessment [42-44].
18. Adverse events
Adverse events are undesirable and unintended effects of
treatments and procedures, and they may not necessarily be
related to trial intervention. Adverse events will be compiled
into CRFs based on vital signs, medical history, and clinical
evaluation at every visit. Serious adverse events will be
reported to the institutional review board and monitored
by a designated agent within 24 hours of reporting until
resolution. Researchers will classify these events as treatment-
related or unrelated, and examine their incidence.
19. Statistical analysis
The full analysis set will be utilized to compare the
intervention and control groups. Statistical analysis will
involve two-tailed tests, with a significance level of 5%. All
analyses will be performed using SAS ® Version 9.4 (SAS
instrument, Inc., Cary, NC). Missing data will be applied
intent-to-treat with multiple imputation.
Demographic and clinical characteristics will be presented
as descriptive statistics for each group, including sex, age,
and medical and drug administration history. Continuous
variables will be compared using the independent t-test or
Wilcoxon rank sum test; summary statistics will be presented
as means and standard deviations. A 95% confidence interval
will be reported, as required. Categorical variables will be
compared using the chi-squared test or Fisher’ exact test;
summary statistics will be frequencies and percentiles.
The primary outcome measure will be the difference in
VAS score at visit eight relative to the baseline value. This
effect will be analyzed using covariance analysis, with
baseline VAS values and age as covariates and fixed factors
per group. If there is a clinical difference between each group
among the demographic and pre-treatment characteristics, it
will be added and stratified as a covariate, as necessary.
Secondary outcomes will be analyzed according to the
primary protocol. Categorical variables will be examined
using the chi-squared test or Fisher’s exact test. The paired
t-test or Wilcoxon signified-rank test will be used for the
first and second efficacy evaluation variables to analyze the
difference in pre-treatment measurements within each group,
and repeated measures analysis of variance will be performed
to test the difference in trend changes after treatments.
Dunnett's procedure will be used to correct for multiple
comparisons. Safety evaluation will involve the analysis of
adverse and serious event frequencies, provided the events are
attributed to the study treatment.
20. Withdrawal and dropout
The investigators will record the reasons for study drop-out
and treatment discontinuation. Participants enrolled in the
study will be excluded from analyses despite not complying
with the eligibility criteria. If serious adverse events attri­
butable to the study treatment occur, the study may be
discontinued.
21. Ethical approval and monitoring
This study was approved by the Institutional Review Board
of Daejeon University Daejeon Korean Medicine Hospital
(DJDSKH-22-BM-05) and was registered at the Clinical
Research Information Service and International Clinical
Trials Registry Platform of the World Health Organization
(identifier, KCT0007416). The study protocol complies with
the principles of the Declaration of Helsinki.
All participants will be provided with sufficient infor­
mation about the study before being asked to sign an
informed consent form. The participants may withdraw
from the study at any time without any disadvantage; all
participant data are confidential. After the study completion,
an independent researcher will analyze the data compiled
through CRFs and source documents stored separately, as
stipulated by the Institutional Review Board (IRB) regulations
of Daejeon University Daejeon Korean Medicine Hospital.
A clinical research associate will monitor study compliance
with the trial protocol and the applicable standards and
regulations. Monitoring is planned at a minimum of three
timepoints: site initiation visit, interim monitoring visit,
and site closing visit. Interim monitoring will be conducted
when five participants are enrolled or once a month, and
the schedule will be adjusted according to the recruitment
situation.
www.journal-jams.org 83

22. Recruitment
Participants will be recruited through advertisements
posted on hospital boards and online, as well as those posted
on regional bulletin boards and public transportation. Study
recruitment began in July 2022.
DISCUSSION
A pragmatic/practical clinical trial (PCT) is used to
inform decisions in clinical practice [45]. PCT involves
randomization into intervention and control groups, as does
a randomized controlled trial. However, while a randomized
trial assesses intervention efficacy in a perfect situation, PCT
evaluates its effectiveness in routine care, which involves
treatment personalization. In addition, PCT findings have
high generalizability and can easily be translated into
practical clinical situations [46].
In Korean Medicine research, trials are conducted to
evaluate the treatment safety and effectiveness [39]. It has
been suggested that PCTs should be conducted before
performing randomized controlled trials [47]. A recent study
compared outcomes of surgical and rehabilitation-based
interventions for chronic low back pain [48]. In this study,
surgery was recommended at the physician’s discretion rather
than being prescribed by the study protocol. Other studies
have evaluated the effectiveness of pharmacopuncture for
cervical pain using PCTs [49].
Korean Medicine tends to customize treatments; this
feature is difficult to represent in conventional randomized
clinical trials, which require that treatment protocols be
pre-specified regardless of participant needs. This design
limitation precludes meaningful conclusions, given the high
heterogeneity of pharmacopuncture. Accordingly, this pilot
trial used a PCT design to reflect clinical practice.
Pragmatic Explanatory Continuum Indicator Summary
(PRECIS) is a tool to help ascertain whether a trial is
pragmatic or explanatory using a continuum [50]. This tool
has been improved and validated to create PRECIS-2, which
covers nine domains: eligibility criteria, recruitment, setting,
organization, flexibility (delivery), flexibility (adherence),
follow-up, primary outcome, and primary analysis, which are
scored on a scale from 1 point (very explanatory) to 5 points
(very pragmatic) [51].
Herein, the eligibility is given a score of 4 points, reflecting
the recruitment of a broad spectrum of patients with
limitations in age and VAS scores. Similarly, recruitment is
given a score of 4 points, as diverse advertisements were used
to reach diverse subjects. Setting could be given a score of 3
points due to the single-center nature of this study, which is
based at a tertiary healthcare institution. Organization could
be assigned a score of 4 points, as we planned imaging and
84 www.journal-jams.org
Hyun Ji Cha, et al.
laboratory evaluations, which are difficult to perform at other
Korean Medicine clinics. Flexibility (delivery) is given a score
of 5 points because this study lacks a predefined treatment,
which is at the administrator’s discretion and determined by
patient presentation. Flexibility (adherence) could be given
a score of 4 points, as we recruit participants who can visit
frequently during the study period. Follow-up could be given
a score of 2 points because the participants are required to
complete questionnaires and in-person assessments. The
primary outcome domain could be given a score of 5 points,
as the primary outcome of this study is VAS for shoulder
pain, which captures patient symptoms. The primary analysis
could be given a score of 5 points, as we planned an intent-to-
treat analysis using data from the CRFs.
The National Institute for Korean Medicine Development
[52] recommends conventional acupuncture along with
warm acupuncture, cupping, pharmacopuncture, and
chuna. Pharmacopuncture is a type of acupuncture that is
performed in combination with other modalities rather than
alone. Pharmacopuncture may be suitable for adults with
shoulder pain. However, evidence of pharmacopuncture use
is considered low, and the effectiveness of this treatment is
unclear. Therefore, this study aims to compare outcomes
of acupuncture alone and acupuncture combined with
pharmacopuncture for rotator cuff disease. Both interventions
will be performed, and the outcomes will be compared.
The limitations of this study include the small sample
size and the short intervention period. Owing to the
pragmatic nature of the research design, the participants
and administrators will not be blinded to the interventions.
However, blinded assessors will perform outcome evaluations
to overcome bias. Moreover, the continuity and safety
of the treatments can be evaluated by setting a 4-week
treatment period and a 4-week follow-up period after the last
treatment. This pragmatic, randomized controlled, parallel-
group clinical study may help evaluate the contribution of
acupuncture and pharmacopuncture to the non-surgical
treatment of rotator cuff disease.
FUNDING
This study was financially supported by grants from
the project KSN2022210 of the Korea Institute of Oriental
Medicine (KIOM), Republic of Korea.
AUTHORS' CONTRIBUTIONS
YIK and CHH determined the study design as principal
investigators and were responsible for the final decision to
submit the manuscript for publication. HJC, JHJ, HKK, CHH,
and IHH designed the study. HJC drafted the manuscript.
Pharmacopuncture for Rotator Cuff Disease
JHJ, JKJ and YIK conducted intervention. JHJ and JKJ revised
the manuscript. BKK determined the statistical analysis
procedures. BKK, MJK, YEC and CY provided technical
advice and made critical revisions to the study. All the authors
read and approved the final manuscript.
INSTITUTIONAL REVIEW BOARD
STATEMENT
This study was approved by the Institutional Review Board
of Daejeon University Daejeon Korean Medicine Hospital
(DJDSKH-22-BM-05, 2022-04-29) and was registered at the
Clinical Research Information Service and International
Clinica l Tria ls Registr y Platform of World Hea lt h
Organization (identifier: KCT0007416). The study protocol
complies with the principles of the Declaration of Helsinki.
INFORMED CONSENT STATEMENT
Informed consent will be obtained from all the subjects
enrolled in the study.
DATA AVAILABILITY STATEMENT
The data from this trial will be accessible to other
researchers upon reasonable request from the corresponding
author. The trial findings will be disseminated through open-
access journals and at national and international conferences.
CONFLICT OF INTEREST
The authors declare no conflict of interest.
ORCID
Hyun Ji Cha, https://orcid.org/0000-0003-3791-5266
Chang-Hyun Han, https://orcid.org/0000-0003-4285-3063
Ju Hyun Jeon, https://orcid.org/0000-0001-6666-7922
Jeong Kyo Jeong, https://orcid.org/0000-0001-5917-2358
Hong Kyoung Kim, https://orcid.org/0000-0002-8893-5112
Changsop Yang, https://orcid.org/0000-0003-1277-3329
Byoung-Kab Kang, https://orcid.org/0000-0002-3016-2428
Min Ji Kim, https://orcid.org/0000-0001-5806-964X
Young Eun Choi, https://orcid.org/0000-0001-6915-3716
In-Hyuk Ha, https://orcid.org/0000-0002-5020-6723
Young Il Kim, https://orcid.org/0000-0001-9221-3238
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