European Journal of Integrative Medicine 8 (2016) 373–383

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European Journal of Integrative Medicine

journal homepage: www.elsevier.com/eujim

Research paper

Acupuncture for shoulder pain after stroke: A randomized controlled

clinical trial
Go Eun Leea, Chihyoung Sona,*, Jungsup Leeb, Sook Hyun Leec, Hye Jin Leed, Kuem Ju Leec,
Sung Min Limc, Hyun Choic, Dong A Kimd, Wan Ho Kimd
a
Department of Korean Traditional Rehabilitation Medicine, Korean National Rehabilitation Center, Seoul, Republic of Korea
b
Department of Korean Traditional Internal Medicine, Korean National Rehabilitation Center, Seoul, Republic of Korea
c
Department of Clinical Research for Rehabilitation, Korean National Rehabilitation Research Institute, Seoul, Republic of Korea
d
Department of Rehabilitation Medicine, Korean National Rehabilitation Center, Seoul, 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 evaluated the clinical efficacy and safety of acupuncture for the treatment of
Received 26 April 2016 shoulder pain after stroke.
Received in revised form 28 June 2016 Methods: This prospective randomized, sham-controlled clinical trial was conducted from May 2013 to
Accepted 28 June 2016
December 2013. Subacute or chronic stroke patients with shoulder pain were randomly allocated into
either the acupuncture or sham acupuncture (non-acupuncture point shallow penetrating acupuncture)
Keywords: group. Acupuncture was offered to each patient three times a week for 3 weeks, and clinical outcomes
Acupuncture
were assessed during 3 weeks of treatments and 1 week of follow-up using the following assays: the
Randomized controlled trial
Shoulder pain after stroke
Visual Analog Scale (VAS), the Pain Rating Scale (PRS), Passive Range of Motion (PROM), the Manual
Post-stroke shoulder pain Muscle Test (MMT), the Modified Ashworth Scale (MAS), the Korean version of the Beck Depression
Sham acupuncture Inventory (K-BDI) and the Korean Modified Barthel Index (K-MBI). Adverse events were monitored
throughout the study.
Results: Fifty-three participants were included in this study (27 in the acupuncture group and 26 in the
sham acupuncture group). At the 3rd week, there were significant differences between the two groups in
the mean change in the VAS (mean difference: 2.13, 95% CI: [0.72, 3.54]) and PRS (mean difference: 19.41
[5.70, 33.12]). However, there were no significant differences between the two groups on the PROM,
MMT, MAS, K-MBI, or K-BDI at any measurement point. Adverse events related to acupuncture treatment
were not reported.
Conclusion: In this study, we found that acupuncture treatment is effective in reducing shoulder pain after
stroke. The long-term effect of acupuncture must be assessed in future studies.
ã 2016 The Authors. Published by Elsevier GmbH. This is an open access article under the CC BY-NC-ND
license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

1. Introduction stimulation, ultrasound, taping, acupuncture and herbal medicine,

Shoulder pain is one of the most common complications after
stroke and interferes with the activities of daily living and
rehabilitative treatment [1]. One study reported that over 70% of
stroke patients suffer from shoulder pain [2]. Shoulder pain after
stroke is associated with subluxation, spasticity, and contracture,
which originate with a change in muscle balance due to upper
motor neuron disorders [3]. Therefore, various treatment methods,
such as non-steroidal anti-inflammatory drugs, steroid injections,
positioning and handling, shoulder strapping, electrical
have been suggested to relieve pain [4]. Currently, acupuncture is
used to treat many medical problems, particularly chronic pain [5],
and shoulder pain is one of the indications that is most amenable
to treatment with acupuncture [6]. Furthermore, the incidence of
adverse events is lower than that of opioid analgesics and anti-
inflammatory medications [7].
Recent studies of acupuncture for shoulder pain after stroke
reported that acupuncture groups showed significant improve-
ments in pain compared with control groups [8,9]. The latest
systematic review of acupuncture for shoulder pain after stroke

* Corresponding author at: Korean National Rehabilitation Center, 58 Samgaksan-ro, Ganbuk-gu, Seoul, 01022, Republic of Korea.
E-mail addresses: poupee15@naver.com (G.E. Lee), cecilson@hanmail.net (C. Son), uni0700@korea.kr (J. Lee), sh00god@khu.ac.kr (S.H. Lee), entreciel80@nrc.go.kr
(H.J. Lee), kjlee74@korea.kr (K.J. Lee), universalism@korea.kr (S.M. Lim), choi1h@korea.kr (H. Choi), kana69@nrc.go.kr (D.A. Kim), whykim@nrc.go.kr (W.H. Kim).

http://dx.doi.org/10.1016/j.eujim.2016.06.020
1876-3820/ã 2016 The Authors. Published by Elsevier GmbH. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/
4.0/).
374 G.E. Lee et al. / European Journal of Integrative Medicine 8 (2016) 373–383
concluded that acupuncture is effective for the treatment of
shoulder pain after stroke [10]. However, the methodological flaws
of the included studies precluded the gathering of conclusive
evidence on the use of acupuncture for shoulder pain after stroke
[11]. Therefore, well-designed trials with improved methodologi-
cal quality, including allocation concealment and the blinding of
outcome assessors, are necessary to confirm the clinical effective-
ness of acupuncture [10]. Current clinical trials of acupuncture for
stroke patients suffering from shoulder pain included patients
with shoulder pain from shoulder-hand syndrome [12,13] and
shoulder subluxation [14], which might not be directly related to
the shoulder pain after stroke. Additionally, these studies did not
incorporate sham acupuncture, which is an important control
intervention to evaluate the nonspecific effect of acupuncture.
Instead, previous studies used other types of acupuncture [9] or
drugs [15] for the control groups.
Thus, we designed a randomized controlled clinical trial to
investigate whether acupuncture is more effective than sham
acupuncture and is safe to use for the treatment of shoulder pain
after stroke.
The first hypothesis in this study is that acupuncture treatment
for shoulder pain after stroke would be significantly more effective
than sham acupuncture at the 3rd weeks of treatment. Our second
hypothesis is that the effect of acupuncture treatment would be
sustained for 1 week after treatment.
2. Methods
2.1. Study design
This study was a prospective randomized, patient-assessor-
blinded, sham-controlled clinical trial with two parallel arms
conducted from May 2013 to December 2013 at the Korean
National Rehabilitation Center, Seoul. The study protocol was
approved by the Institutional Review Board of the Korean National
Rehabilitation Center (NRC201206040).
The study protocol was registered with the Clinical Research
Information Service (CRIS) of the Republic of Korea (KCT0000988).
We followed the WMA Declaration of Helsinki—Ethical
Principles for Medical Research Involving Human Subjects.
2.2. Recruitment and participants
2.2.1. Recruitment
Participants who were hospitalized in the National Rehabilita-
tion Center were recruited through advertisements in the hospital.
Written informed consent was obtained from each patient before
participation. During the trial period, the participants did not know
to which group they had been allocated. If the participants desired
to know their group allocation, we disclosed this information to
the participants after completion of the trial.
2.2.2. Eligibility criteria for participants
Inclusion criteria were as follows: (1) more than 4 weeks after
stroke; (2) aged 20 years or older; (3) a score of 4 on the visual
analog scale (VAS) for hemiplegic shoulder pain; and (4) subjects
without a previous history of shoulder injury or shoulder
operation. Exclusion criteria were as follows: (1) patients who
received acupuncture treatment for hemiplegic shoulder pain
within the past month; (2) patients who experienced hypersensi-
tivity following acupuncture; (3) patients whose prior medical
history included pacemakers, embedded neural stimulators,
cardiac arrhythmia, epilepsy, or peripheral neural injury; (4)
cognitive impairment that precluded the accurate clinical assess-
ment of the VAS score; (5) patients who had another central
nervous disease or severe neurological or psychiatric symptoms
(e.g., psychosis, major depressive disorder, dementia) or were
taking antipsychotic medication; (6) patients who had communi-
cation difficulties or who did not provide informed consent; and
(7) other patients who were considered inappropriate for
participation in this trial by the conductors of the trial.
2.2.3. Sample size
Based on the results of the previous study on the effectiveness
of acupuncture for shoulder pain after stroke, we established a
significance level of more than 95%, a power of 80%, a 1.29-point
difference in the mean change and a standard deviation of 1.66 on a
0- to 10-point scale. Considering an expected 15% drop-out rate, we
planned to enroll 60 patients in the study [16].
2.2.4. Allocation and randomization
Stroke patients who wanted to participate in the study were
screened for eligibility through a chart review and interview on the
first visit and were randomized to the acupuncture or the sham
acupuncture group.
Random numbers were generated with a statistical software
package (IBM SPSS Statistics for Windows, Version 21.0, Armonk,
NY: IBM Corp., 2012) with a block size of 4. Allocation concealment
was conducted using the concealed opaque envelope method.
Randomization was performed by an independent researcher who
was not involved in the inclusion or exclusion process, treatment
and assessment procedures.
2.2.5. Blinding
Participants were blinded to the assigned treatment. The
outcome assessor was also blinded to the group assignments and
was trained to apply the pain scales and conduct physical tests. To
avoid unblinding of the assessment of outcomes, the participants
were instructed not to discuss any aspect related to their treatment
with the assessor.
2.3. Intervention
Both the acupuncture and sham acupuncture protocols were
developed with the consensus of an expert committee composed
of professors and researchers who specialize in traditional Korean
medicine and were based on a literature review and an
acupuncture textbook [17]. All treatment sessions were adminis-
tered by three traditional Korean medical doctors.
Participants were treated by acupuncture or sham acupuncture
three times per week for 3 weeks (for a total of 9 sessions over 3
weeks).
2.3.1. Acupuncture group
Ten needles were inserted at each session, and the unilateral
(hemiplegic side) LI15, LI14, LI16, LI4, TE14, TE3, SI10, SI13, GB20
and ST36 were used for acupuncture treatment [18–20] (Fig. 1).
Disposable, sterilized, stainless steel needles (Dongbang
Acupuncture Inc., Seoul, Korea; length 40 mm, diameter
0.25 mm) were inserted to a depth of 15–35 mm. All needles were
rotated manually at least once at each session to elicit needle
sensation (De qi). The needle retention time was 15 min.
2.3.2. Sham acupuncture group
Participants allocated to the sham acupuncture group received
acupuncture treatment at 10 body points. We used a form of sham
acupuncture with superficial penetration (less than 15 mm
insertion without needle manipulation) near the points of the
upper arm (2 points at the medial 1/3 and lateral 3/2 between LI11
and LU4), the back (3 points at the same height with GV8, GV9,
GV10 at the subscapular area), the scalp (2 points 30 mm posterior
to BL8), and the leg (3 points 30 mm inferior to the mid-point
 G.E. Lee et al. / European Journal of Integrative Medicine 8 (2016) 373–383 375

Fig. 1. The acupoints in the experimental group and non-acupoints in the sham acupuncture group.
Ten needles were inserted at each session, and the unilateral (hemiplegic side) LI15, LI14, LI16, LI4, TE14, TE3, SI10, SI13, GB20 and ST36 were used for acupuncture treatment.
The minimal acupuncture points were located on the upper arm (2 points at the medial 1/3 and lateral 3/2 between LI11 and LU4), the back (3 points at the same height as GV8,
GV9, and GV10 in the subscapular area), the scalp (2 points 30 mm posterior to BL8), and the leg (3 points 30 mm inferior to the mid-point between ST36 and GB34). Red stars
represent real acupuncture points in the experimental group, and blue dots represent non-acupoints in the sham acupuncture group.

between ST36 and GB34) for 15 min. We utilized different
acupuncture points to minimize the nonspecific effect of sham
acupuncture.
2.3.3. Education of practitioners
All treatments were performed by 3 traditional Korean medical
doctors certified by the Korean Ministry of Health and Welfare who
had at least 6 years of education in traditional Korean medicine and
at least 4 years of clinical experience. Each doctor took a pre-trial
training course for this clinical research. The lead doctor, who
specialized in acupuncture, trained the other practitioners and
observed their techniques periodically to ensure standardization
among practitioners. During the treatment period, any discussion
related to treatment between the participants and the traditional
Korean medical doctor was restricted to a minimum of necessary
explanations to ensure the success of the blinding procedure.
2.3.4. Concomitant treatments
All participants were treated with conventional rehabilitative
treatments, including physical therapy, occupational therapy and
heat-electromechanical therapy (heat pack, Interferential Current
Therapy (ICT)), during the period of study.
Physical therapy and occupational therapy were conducted
twice daily for 30 min per session, for a total of 10 sessions per
week. Additionally, heat-electromechanical therapy (heat pack,
ICT) was conducted once daily for 15 min per session for a total of 5
sessions per week.
All participants were allowed to take an analgesic medicine
prescribed by the rehabilitation doctors. During the trial period, it
was not permitted that other analgesic medicines were added or
that doses were increased.
However, injection treatments for hemiplegic shoulder pain
were prohibited during the study period in both groups.
2.4. Outcome measures
The protocol of assessments and treatments was as follows.
Baseline assessment (BA) was performed on the first day of the
study. The first to third treatments (Tr1-3) were conducted within
one week on different days. Assessment at the 1 st week (A1w) was
performed 1 week after BA. Tr4-6, A2w, Tr7-9, A3 w were
conducted in order, and a follow-up assessment (FA) was
performed 1 week after treatment. The treatments and assess-
ments were conducted on different days.
2.4.1. Primary outcome measures
The primary outcome measure was the pain level experienced
by the patients, which was assessed by the VAS. The VAS is a simple
tool consisting of a 10-cm line with 0 on one end representing no
pain and 10 on the other end representing the worst pain. Patients
were asked to answer the following question: how intense was
your average pain during the past week? Pain was assessed at BA,
A1W, A2W, A3 W and FA for a longitudinal analysis. Of those
assessment points, A3 W was the primary end-point for analysis.
2.4.2. Secondary outcome measures
The Pain Rating Scale (PRS) [21] included the pain intensity (0–
10), pain duration (0–5), pain frequency (0–5), and aggravating
activity depending on movement (0–5). The total PRS score was
calculated as the score of pain intensity  (pain duration + fre-
quency + aggravating activity). The total PRS score sensitively
376 G.E. Lee et al. / European Journal of Integrative Medicine 8 (2016) 373–383

reflects the changes of pain and was assessed at BA, A1W, A2W,
A3 W and FA (similar to the VAS).
The Passive Range of Motion (PROM) test evaluates the painless
passive range of motion of the involved shoulder. PROM was
passively assessed while the patient was sitting in three positions
(flexion, abduction, and extension). For each patient, measure-
ments were manually collected using a goniometer.
The Manual Muscle Test (MMT) is the most commonly used
method for documenting impairments in muscle strength [22,23].
We assessed the flexor, extensor, abductor and adductor muscle
groups of the shoulder joint on a scale from 0 to 5, where 0
represents no activity in the muscle and 5 represents full/normal
activity of the tested muscle or muscle group.
Spasticity of the upper flexor muscles was measured for the
involved shoulder using the modified Ashworth scale (MAS). The
MAS is a six-point ordinal scale used to grade the resistance
encountered during passive muscle stretching. MAS grades are as
follows: 0 = no increase in muscle tone; 1 = slight increase in

Fig. 2. Flow chart of participants’ progress duringthe trial.

A total of 53 patients (27 in the acupuncture group and 26 in the sham acupuncture group) were enrolled in the study. Forty eight subjects (90.5%) completed the study
without protocol violations.
 G.E. Lee et al. / European Journal of Integrative Medicine 8 (2016) 373–383 377

muscle tone, manifested by a catch and release or by minimal
resistance at the end of the range of motion when the affected part
(s) is moved in flexion or extension; 1 + =slight increase in muscle
tone, manifested by a catch, followed by minimal resistance
throughout the remainder (less than half) of the ROM; 2 = more
marked increase in muscle tone through most of the ROM, but the
affected part(s) are easily moved; 3 = considerable increase in
muscle tone, passive movement difficult; 4 = affected part(s) rigid
in flexion or extension [24,25].
PROM, MMT and MAS were assessed at BA, A2 W and FA.
The Korean version of the Beck Depression Inventory (K-BDI)
was used to measure depressive mood. The K-BDI, which is a 21-
item self-administered questionnaire, was developed to assess the
severity of subjective depression. Scores were obtained by
summing responses with higher scores indicating more strongly
perceived depression [26].
The Korean Modified Barthel Index (K-MBI) is a measure of the
activities of daily living, which reflects the patient’s degree of
independence. Total scores may range from 0 to 100 with higher
scores indicating greater independence [27].
The K-BDI and K-MBI were assessed at BA and FA.
2.4.3. Safety
Adverse events were monitored throughout the study by the
participants’ self-reported subjective and objective symptoms
(e.g., pneumonia, bleeding, hematoma, syncope). We considered
these events to be mild when the patients did not require
treatment, moderate when patients required treatment without
dropping out, and severe when patients required treatment with
dropping out.
2.5. Statistical analyses
The intent-to-treat (ITT) analysis included all randomized
participants classified according to their randomization, irrespec-
tive of their completion of acupuncture or sham treatments.
Missing data in dropouts were replaced using the last-observation-
carried-forward method. We used Student’s t-tests and the Chi
square test to compare the baseline characteristics of the 2 groups.
The independent t-test and repeated-measures ANOVA (RMA-
NOVA) were used for between-group comparisons and to evaluate
changes in the outcome measures (VAS, PRS, K-MBI, K-BDI, and
PROM). Changes in the MMT and MAS from baseline were classified
into 3 groups (improved, unchanged, or worse). Fisher's exact test
was used to analyze the MAS and MMT changes from baseline to
the 2nd week of treatment and 1 week after treatment, and the
results were classified into three groups (improved, unchanged, or
worse).
Repeated-measures ANOVA was applied to evaluate the effect
of acupuncture treatment on the VAS and PRS measures over 4
time points from baseline to 1, 2 or 3 weeks of treatment or to the
follow-up visit to compare the 2 groups (acupuncture versus sham
acupuncture). The quantitative data are presented as the mean 
standard deviation and 95% confidence interval, and categorical
data are presented as numbers (percentages).
Effect size was calculated using the Effect Size Calculator by Dr.
Lee A. Becker (http://www.uccs.edu/lbecker/). Cohen’s d repre-
sents the effect size as follows: small effects (0.2), medium effects
(0.5) and large effects (0.8) [28].
IBM SPSS Statistics version 21.0 was used for the analyses.
Results were considered significant on a comparison-wise basis at
an a equal to 0.05 for 2-tailed tests.
3. Results
3.1. Participants
A total of 135 patients were interested in participating in this
study, and 53 patients were enrolled in the study (Fig. 2). The
reasons for exclusion were lack of shoulder pain (n = 39, 29%),
communication disorder (n = 35, 26%), cervical herniated nucleus
pulposus disc (n = 1, 0.7%), cardiac disease (n = 1, 0.7%), asthma
(n = 1, 0.7%), and previous history of shoulder operations (n = 5, 4%).
Twenty-seven subjects were assigned to the acupuncture
group, and 26 subjects were assigned to the sham acupuncture
group.
Twenty-three acupuncture subjects and 25 sham acupuncture
subjects completed the treatment protocol. Thus, 48 subjects

Table 1
Baseline demographic and clinical characteristics of the participants.

Characteristics All (N = 53) Acupuncture group (N = 27) Sham Acupuncture group (N = 26) P-value

Age (years) 57.58  11.25 56.81  10.23 58.38  12.38 0.31(a)

Sex (N) Male 35 (66%) 15 (56%) 20 (77%) 0.10(b)
Female 18 (34%) 12 (44%) 6 (23%)
Time since Stroke Less than 6 Months 51 (77%) 23 (85%) 18 (69%) 0.17(b)
Over 6 Months 12 (23%) 4 (15%) 8 (31%)
Type of Stroke ICH 14 (26%) 7 (26%) 7 (27%) 0.93(b)
Infarction 39 (74%) 20 (74%) 19 (73%)
Stroke lesion Right 17 (32%) 8 (30%) 9 (35%) 0.70(b)
Left 36 (68%) 19 (70%) 17 (65%)
Analgesics None taken 29 (55%) 16 (59%) 13 (50%) 0.50(b)
Taken 24 (45%) 11 (41%) 13 (50%)
Duration of Shoulder Pain Less than 3 Months 25 (47%) 13 (48%) 12 (46%) 0.90(b)
3–6 Months 21 (40%) 10 (37%) 11 (42%)
Over 6 Months 7 (13%) 4 (15%) 3 (12%)
VAS 6.85  2.01 7.15  1.85 6.54  2.16 0.28(a)
PRS 55.77  27.05 59.30  28.60 52.12  25.38 0.34(a)
MMT Below Grade 3 25 (47%) 15 (56%) 10 (38%) 0.21(b)
Over Grade 3 28 (53%) 12 (44%) 16 (62%)
MAS Below Grade 2 30 (57%) 13 (48%) 17 (65%) 0.21(b)
Over Grade 2 23 (43%) 14 (52%) 9 (35%)
PROM Flexion 108.66  19.48 104.33  21.12 113.15  16.87 0.10(a)
Extension 49.06  12.29 49.07  10.75 49.04  13.93 0.99(a)
Abduction 85.55  22.85 84.33  19.70 86.81  26.06 0.70(a)
K-MBI 56.75  22.24 54.44  19.37 59.15  25.04 0.44(a)
K-BDI 16.62  12.36 16.74  12.53 16.50  12.42 0.94(a)

Data were analyzed by the independent t-test (a) or chi-square test (b).
378 G.E. Lee et al. / European Journal of Integrative Medicine 8 (2016) 373–383

Table 2
Differences in the changes of VAS from baseline to the 1st, 2nd, or 3rd week of treatment and to 1 week after treatment.

Differences in VAS Acupuncture group (n = 27) Sham acupuncture group (n = 26) Mean difference between groups P-value (between-group difference)

Mean  SD (95% CI) Mean  SD (95% CI) Mean  SE (95% CI)

After 1 week 2.15  2.48 1.12  2.03 1.03  0.62 0.103
( 0.22–2.28)
After 2 weeks 2.44  2.78 1.38  2.23 1.06  0.69 0.133
( 0.33–2.45)
After 3 weeks 3.52  2.67 1.38  2.43 2.13  0.70 0.004**
(0.72–3.54)
1 week 3.00  3.28 1.65  2.50 1.34  0.80 0.099
after treatment ( 0.27–2.96)

Data were analyzed by the independent t-test at each point of measurement.

**
p < 0.01.

(90.5%) completed the study without protocol violations. Five
subjects (4 from the acupuncture group, 1 from the sham
acupuncture group) withdrew consent due to personal problems
(long travel time to attend appointments or pressed for time). Two
subjects dropped out during the 1 st week of treatment, 1 subject
dropped out during the 2nd week of treatment, and 2 subjects
dropped out during the 3rd week of treatment. None of the missed
visits were due to illnesses, worsening pain, or any issues related to
the clinical trial.
3.2. Baseline characteristics of subjects
There were no significant differences between groups with
respect to baseline characteristics and outcomes (VAS, PRS, MMT,
MAS, PROM, K-MBI and K-BDI) (Table 1).
The mean of age of the subjects was 57.58  11.25. The subjects
were predominantly composed of males and the patients
experienced an infarction, less than 6 months since the occurrence
of stroke with anda duration of shoulder pain less than 3 months.
3.3. Primary outcome measures
3.3.1. Changes in VAS scores
Considering the changes in the VAS score from baseline to each
measurement period, the acupuncture group demonstrated a
significant change compared with the sham acupuncture group at
the 3rd week of treatment (mean difference: 2.13, 95% CI [0.72,
3.54], p = 0.004) but not at 1 week after treatment (mean
difference: 1.34, 95% CI [ 0.27, 2.96], p = 0.099) according to the
independent t-test (Table 2, Fig. 3).
The repeated-measures ANOVA revealed that the interaction
between time and group was significant (F = 3.158, p = 0.022).
The effect size (Cohen’s d) of changes in the VAS was 0.84,
representing a large effect.
3.4. Secondary outcome measures
3.4.1. PRS
Significant differences between the two groups were observed
in the change in the total PRS scores from baseline to the 3rd week
 G.E. Lee et al. / European Journal of Integrative Medicine 8 (2016) 373–383 379

Table 3
Differences in the changes of the total PRS score from baseline to the 1st, 2nd, or 3rd week of treatment and to 1 week after treatment.

Differences Acupuncture group (n = 27) Sham acupuncture group (n = 26) Mean difference between groups P-value (between-group difference)
in PRS score
Mean  SD Mean  SD Mean  SE (95% CI)
After 1 week 19.07  23.95 9.19  23.49 9.88  6.52 ( 3.21–22.97) 0.136
After 2 weeks 27.33  26.49 16.00  24.07 11.33  6.96 ( 2.64–25.31) 0.110
After 3 weeks 35.26  26.22 15.85  23.35 19.41  6.83 (5.70–33.12) 0.006**
1 week 33.96  36.34 15.50  25.98 18.46  8.71 (0.98–35.94) 0.039*
after treatment

Data were analyzed by the independent t-test at each point of measurement.

*
p < 0.05.
**
p < 0.01.

of treatment (mean difference: 19.41, 95% CI [5.70, 33.12],
p = 0.006) and to the 1-week follow-up (mean difference: 18.46,
95% CI [0.98, 35.94], p = 0.039) (Table 3).
The repeated-measures ANOVA model showed that the
interaction between time and group was significant (F = 3.072,
p = 0.034).
The effect size (Cohen’s d) of changes in the PRS was 0.51,
representing a medium effect.
3.4.2. Motor function (MMT), spasticity (MAS) and PROM of the
shoulder joint
The changes in MMT and MAS from baseline, which were
classified into 3 groups (improved, unchanged, worse), were not
significantly different between the two groups at any time point
(Table 4).
The PROM of the shoulder joint (flexion, extension, abduction)
improved slightly in both groups, but there were no significant
differences within or between the groups at any time point
(Table 5).
The effect sizes (Cohen’s d) of changes in the PROM of the
shoulder joint in flexion, extension and abduction were 0.42, 0.01
and 0.001, respectively, representing a medium and small effect.
3.4.3. K-MBI and K-BDI
The change in K-MBI from baseline to 1 week after treatment
was not significantly different between the two groups. However, it
significantly increased within the groups (p = 0.008 for acupunc-
ture group, p = 0.004 for sham acupuncture group) (Table 6).
K-BDI was not significantly different between the groups at
each assessment. The change in K-BDI from baseline was not
significantly different between the two groups. In the acupuncture
group, K-BDI decreased from baseline, whereas it increased in the
sham acupuncture group. However, there were no significant
differences between the groups (Table 6).
The effect size (Cohen’s d) of changes in the K-MBI and K-BDI
were 0.17 and 0.20, respectively, representing small effects.
3.5. Adverse events
In both the acupuncture and sham acupuncture groups, there
were no acupuncture-related adverse events, such as pain,
palpitations, nausea, vomiting, eruptions, bruising, or bleeding.
No serious adverse events were reported. Additionally, the 5
subjects who dropped out did not report any complaints or serious
adverse events.
4. Discussion
This study was performed to determine whether acupuncture
treatment is effective and safe for the treatment shoulder pain
after stroke.
The results showed that shoulder pain after stroke, as measured
by the VAS and PRS, decreased more rapidly in the acupuncture
treatment group than in the sham acupuncture treatment group
up until the 3rd week. However, at follow up, 1 week after
treatment, there was no significant difference between the two
groups. The other secondary outcomes also failed to show any
significant difference between the two groups at 1 week after
treatment.
The exact etiology of post-stroke shoulder pain remains
unknown [29], and many factors are typically involved [30].
According to previous epidemiological and radiological studies,
pain is related to neurological abnormalities, including thalamic
pain [31], sympathetic dystrophy [32] and biomechanical alter-
ations of the hemiplegic limb, resulting in spasmodic or spastic
muscles and contracted joints [33,34]. Repeated micro-traumas to
the shoulder joint may cause chronic pain and exacerbate an
abnormal, regional sensory-sympathetic reflex arc [34].

Table 4
Changes in the MMT and MAS grade from baseline to the 2nd week of treatment and to 1 week after treatment.

Time of assessment Change of Grade Acupuncture group (n=23) Sham acupuncture P-value
n (%) group (n=25)
n (%)
MMT After 2 weeks Worsened 3 (5.7%) 1 (1.9%) 0.558
Unchanged 16 (30.2%) 18 (34%)
Improved 8 (15.1%) 7 (13.2%)
1 week after treatment Worsened 2 (3.8%) 0 (0%) 0.168
Unchanged 12 (22.6%) 17 (32.1%)
Improved 13 (24.6%) 9 (17%)
MAS After 2 weeks Worsened 2 (3.8%) 4 (9.5%) 0.523
Unchanged 22 (41.5%) 17 (32.1%)
Improved 3 (5.7%) 5 (9.4%)
1 week after treatment Worsened 1 (1.9%) 3 (5.7%) 0.409
Unchanged 18 (34.0%) 17 (32.1%)
Improved 8 (15.2%) 6 (11.4%)

Data were analyzed by Fisher’s exact test at each point of measurement.

380 G.E. Lee et al. / European Journal of Integrative Medicine 8 (2016) 373–383

Table 5
Changes in PROM from baseline to the 2nd week of treatment and to 1 week after treatment.

PROM Time Acupuncture group Sham acupuncture group P-value (between-group

of assessment difference)(b)
Mean  SD P-value (within-group Mean  SD P-value (within-group
difference)(a) difference)(a)
flexion Baseline 104.33  21.12 113.15  16.87 0.100
2nd week 104.96  26.94 0.908 113.85  19.09 0.820 0.174
1 week 112.22  19.23 0.030* 113.27  21.26 0.976 0.851
after
treatment
extension Baseline 49.07  10.75 49.04  13.93 0.992
2nd week 50.04  9.35 0.697 51.15  16.75 0.327 0.764
1 week 54.44  9.84 0.060 54.23  13.62 0.099 0.948
after
treatment
abduction Baseline 84.33  19.70 86.81  26.06 0.697
2nd week 88.15  20.76 0.149 87.31  23.03 0.874 0.889
1 week 85.37  19.51 0.766 87.69  25.39 0.810 0.710
after
treatment

Data were analyzed by the dependent t-test (a) and independent t-test (b).*p < 0.05

Table 6
Changes in the total score of K-MBI and K-BDI from baseline to 1 week after treatment.

Items Time of Assessment Acupuncture group Sham acupuncture group P-value (between-group
difference)(b)
Mean  SD P-value (within-group Mean  SD P-value (within-group
difference)(a) difference)(a)
K- baseline 54.44  19.37 59.15  25.04 0.446
MBI 1 week after 63.56  19.23 0.008** 71.31  17.17 0.004** 0.128
treatment
K-BDI baseline 16.74  12.53 16.50  12.42 0.944
1 week after 15.56  14.57 0.455 17.27  12.55 0.737 0.649
treatment

Data were analyzed by the dependent t-test (a) and independent t-test (b).).**p < 0.01.
K-MBI and K-BDI were assessed once per month, which means that this assessment was conducted 1 week after the end of the treatment.

Acupuncture may confer an analgesic effect [35–37]. Several
hypotheses have been proposed to explain the mechanisms of
action of acupuncture on pain relief [36,38]. One of the most
popular theories is the Gate Control Theory [38,39]. The gate that
controls the perception of pain closes during acupuncture. Some
authors attribute the analgesic effects to the release of endorphins,
acetylcholine, 5-hydroxytryptophan and noradrenaline within the
central nervous system [37,39–41]. However, a centrally acting
agent cannot explain why acupuncture is conventionally applied in
close proximity to the locus of pain and why the analgesic effects of
acupuncture are restricted to the ipsilateral side [42,43]. A recent
study found that the triggering of adenosine A1 receptors and the
release of ATP metabolites are central factors in the anti-
nociceptive effects of acupuncture. Adenosine may accumulate
during acupuncture treatments and dampen pain in part by the
activation of A1 receptors on the sensory afferents of ascending
nerve tracks [44].
Some studies have also reported that acupuncture therapy may
not only decrease pain but also improve the shoulder girdle’s range
of motion, relieve paralysis, and decrease spasticity and subluxa-
tion [14,15,45,46].
Therefore, MMT, MAS, PROM, MBI and BDI were selected as
secondary outcomes because these scales are related to pain. This
study showed improvement of the shoulder joint’s PROM in the
acupuncture group, but the improvement was not significant
compared with the sham acupuncture group. Though K-MBI
significantly improved in both groups, there was no significant
difference between the two groups, possibly because the power of
this study was based solely on the VAS.
A range of acupuncture-related adverse events, including
syncope, needle bending, needle sticking, needle breaking, residual
sensations, burns, allergy, hemorrhage, hematoma, pain, infection,
and injury to internal organs or tissues, have been reported
elsewhere [47]. However, none of the participants experienced
adverse events in this study. We were vigilant in conducting proper
procedures with complete sterilization under the guidance of a
certified doctor.
When interpreting the results of this study, certain weaknesses
should be considered. First, the number of subjects enrolled in this
study fell short of the targeted total sample size. This factor
theoretically undermines the study's power to detect differences
between the groups. Originally, we planned on including 60
patients, but the research period that was originally approved by
the institution ended before we could recruit 60 participants.
However, because the statistical power of 53 participants was
86.3%, greater than the planned 80%, the results of this study
represent the efficacy of acupuncture treatment with shoulder
pain after stroke. The effect size calculated by the VAS also showed
a large effect (Cohen’s d = 0.84).
It is controversial whether superficial penetrating sham
acupuncture (minimal acupuncture) may have an effect similar
to real acupuncture [48]. Some research has suggested that
minimal acupuncture on the skin has been used in traditional
Chinese medicine and can also affect body systems similar to real
acupuncture [49]. Non-penetrating sham acupuncture could not
be used, as it would be easily recognized by many people in Korea
who have previously experienced acupuncture and therefore make
blinding impossible [50]. Therefore, we decided to use superficial
 G.E. Lee et al. / European Journal of Integrative Medicine 8 (2016) 373–383 381

penetrating sham acupuncture on non-acupoints. According to Conflicts of interest

research, using sham acupuncture as a control group may
underestimate the efficacy of acupuncture treatment [51].
Although this study revealed a significant improvement in pain
as measured by the VAS in the acupuncture group compared with
the minimal acupuncture group, the efficacy of the acupuncture
treatment may have been underestimated.
The side effects of this study might also be underestimated
because the participants who had experienced hypersensitivity to
acupuncture because of IRB were excluded. Although we tried to
overcome the selection bias through the recruitment advertise-
ment and the method of randomization, there may have been some
limitations due to the sampling process in recruiting participants,
but it is hard to control the motivation of participants. Finally, the
follow-up period was short, and the long-term effect of acupunc-
ture on pain was not determined.
Despite these limitations, this study is important because we
utilized rigorous statistical analyses in a prospective randomized
controlled trial and tried to remove the biases. This study provides
some positive evidence suggesting the effectiveness of acupunc-
ture on shoulder pain after stroke.
Future studies should control for the exact number of treat-
ments required and have a longer follow-up period for monitoring
the long-term effects and cost effectiveness of acupuncture.
5. Conclusions
Acupuncture treatment led to a significant improvement in
shoulder pain after stroke at the 3rd week of treatment without
critical side effects. However, short term acupuncture effects on
pain were not observed by 1 week after treatment, and significant
acupuncture effects on the PROM, MMT, MAS, K-MBI, and K-BDI
were not observed.
There are no conflicts of interest in this study.
Author contributions
CHS conceived the trial together with JSL, SHL, KJL, SML, CH,
DAK and WHK. CHS drafted the manuscript and the design of the
acupuncture and sham acupuncture treatments with GEL. JSL
conducted the acupuncture and sham acupuncture treatments.
SHL evaluated the assessment tools. KJL conducted allocation and
randomization. HJL, DAK and WHK were involved in the diagnoses.
GEL prepared the manuscript with CHS and SHL. DAK and WHK
reviewed the manuscript. All authors read and approved the final
manuscript.
Financial support
This study was supported by the Korean National Rehabilitation
Center, Ministry of Health & Welfare, Government of the Republic
of Korea (13-B-04).
Acknowledgements
We appreciate the researchers who assisted us with their
helpful discussion.
This research was supported by a grant (#13-B-04) from the
National Rehabilitation Center Research Institute.
Appendix.
See Tables A1–A3.

Table A1
Acupuncture interventions according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA).

STRICTA ITEM Details

Acupuncture rationale
a. Style of acupuncture
b. Reasoning for treatment provided
c. Extent to which treatment was varied The practitioner followed a fixed acupuncture protocol.
Details of needling
a. Number of needle insertions per
subject per session
b. Names of points used
c. Depth of insertion
d. Response sought
e. Needle stimulation
f. Needle retention time
g. Needle type
Treatment regimen
a. Number of treatment sessions
b. Frequency and duration of treatment Participants were treated by acupuncture or sham-acupuncture three times per week for 3 weeks.
sessions
Other components of treatment
a. Details of other interventions
b. Setting and context of treatment
Traditional Korean Medicine.
This treatment was based on the previous studies and the experiences of experts concerning the acupuncture treatment of
shoulder pain after stoke.
Ten needles were inserted.
Local (LI15, LI14, LI16, TE14, SI10, SI13) and distal (LI 4, TE3) acupuncture points of three meridians were selected, and GB20,
ST36 were combined.
A depth of 15–35 mm.
All needles were rotated manually at least once each session to elicit needle sensation (de qi).
Manual stimulation.
Fifteen minutes.
Disposable, single-use, sterilized, stainless-steel needles (Dongbang Acupuncture Inc., Seoul, Korea; length 40 mm, diameter
0.25 mm).
A total of 9 sessions administered over 3 weeks.
All participants were treated by conventional rehabilitative treatments including physical therapy, occupational therapy and
heat-electromechanical therapy (heat pack, Interferential Current Therapy (ICT)) during the study period. Physical therapy and
occupational therapy were conducted twice daily for 30 min per session, for 10 sessions per week. Heat-electromechanical
therapy (heat pack, ICT) was conducted for once daily for 15 min per session, for 5 sessions per week. All participants were
allowed to take analgesic medication prescribed by rehabilitation doctors before 2 weeks of the study without change of doses
during the study. Injection treatments for hemiplegic shoulder pain were prohibited during the study period in both groups.
Each doctor took a pre-trial training course for this clinical research. The lead doctor, who specialized in acupuncture, trained
the other practitioners and observed their techniques periodically to ensure standardization among practitioners. During the
treatment period, any discussion related to treatment between the participants and the traditional Korean medical doctor was
restricted to a minimum of necessary explanations to ensure the success of the blinding procedure.
382 G.E. Lee et al. / European Journal of Integrative Medicine 8 (2016) 373–383

Table A1 (Continued)
STRICTA ITEM
Practitioner background
Control or comparator interventions
a. Rationale for the control or
comparator
b. Precise description of the control or
comparator
Details
Participants were informed prior to randomization that the purpose of the study was to evaluate the effectiveness of
acupuncture for hemiplegic shoulder pain and they would be allocated to either the treatment group or the control group.
Treatment was performed by 3 traditional Korean medical doctors certified by the Korean Ministry of Health and Welfare who
had 6 years of education in traditional Korean medicine and at least 4 years of clinical experience.
Most Korean subjects had experience with acupuncture; thus, minimal acupuncture with non-classic acupuncture points, a
shallow insertion procedure and the same numbers of acupuncture points on the hemiplegic side, including the brachium and
leg, were used to enhance the credibility of the sham intervention.
The minimal acupuncture points were located on the upper arm (2 points at the medial 1/3 and lateral 3/2 between LI11 and
LU4), the back (3 points at the same height as GV8, GV9, and GV10 in the subscapular area), the scalp (2 points 30 mm posterior
to BL8), and the leg (3 points 30 mm inferior to the mid-point between ST36 and GB34). The needle was inserted to a minimal
depth below 15 mm (just penetrating the skin), and the retention time of the needles was 15 min, the same as in the
acupuncture group. However, in the sham acupuncture group, manual stimulation to elicit needle sensation (de qi) was not
applied. Our unique sham acupuncture procedure employed a superficial insertion procedure and the same numbers of
acupuncture sites on the hemiplegic side, including the brachium and leg, to enhance the credibility of the sham intervention.

Table A2
Changes in VAS from baseline to the 1st, 2nd, and 3rd weeks of treatment and 1 week after treatment.

Assessment time Acupuncture group Sham acupuncture group P-value (between-group difference)
Mean  SD Mean  SD
baseline 7.15  1.85 6.54  2.16 0.275
1 st week 5.00  2.29 5.42  2.06 0.483
2nd week 4.70  2.25 5.15  2.13 0.458
3rd week 3.63  2.26 5.15  2.52 0.024*
1 week after treatment 4.15  2.68 4.88  2.45 0.303

Data were tested by the independent t-test. *p < 0.05, **p < 0.01, ***p < 0.001.

Table A3
Changes in the total PRS score from baseline to the 1st, 2nd, and 3rd weeks of treatment and 1 week after treatment.

Time of Assessment Acupuncture group Sham acupuncture group Between-group difference

Mean  SD Mean  SD
baseline 59.30  28.60 52.12  25.38 0.339
1 st week 40.22  28.69 42.92  19.94 0.693
2nd week 31.96  20.08 36.12  20.02 0.455
3rd week 24.04  18.57* 36.27  25.07* 0.048*
1 week after treatment 25.33  21.02 36.62  25.44 0.084

Data were tested by the independent t-test. *p < 0.05, **p < 0.01, ***p < 0.001.

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