MEDICAL ACUPUNCTURE

Volume 24, Number 2, 2012

# Mary Ann Liebert, Inc.
DOI: 10.1089/acu.2011.0824

Relief of Chronic Shoulder and Neck Pain by Electro-Acupuncture

and Transcutaneous Electrical Nervous Stimulation:
A Randomized Crossover Trial

Madoka Yoshimizu, MPH,1 Alan R. Teo, MD,2 Masahiko Ando, MD,1

Kosuke Kiyohara, DPH,1 and Takashi Kawamura, MD1

ABSTRACT

Background: Chronic neck and shoulder pain is common and disabling.

Objective: The aim of this study was to compare the effectiveness of electro-acupuncture and transcutaneous
electrical stimulation (TENS) for relief of shoulder and neck pain.
Materials and Methods: Design: This was a randomized crossover trial. Subjects: Ninety patients were en-
rolled, with a mean age of 34 years, and with females slightly outnumbering males. All subjects completed the
study. Intervention: For electro-acupuncture, acupuncture needles were placed in four different acupoints in the
trapezius muscle and each subject underwent a 15-minute session of low-frequency electrical stimulation. TENS
treatment was similar and used as an active comparator, with a 2-week washout period between treatments.
Outcome Measures: The primary outcome was reduction in pain as measured by a 100 cm visual analogue scale.
Secondary outcomes included quality-of-life (QoL) measures.
Results: Electro-acupuncture produced significantly greater reduction in pain than TENS did the first 2 days
after treatment ( p = 0.001 and p = 0.003, respectively), with pain decreasing from 56 to 33 and 34 versus from
55 to 42 and 42. Electro-acupuncture also produced a significant improvement in the vitality subscale of the
Short Form-36. No adverse effects or carryover effect were detected.
Conclusions: The results of this study offer preliminary evidence for the comparative effectiveness of electro-
acupuncture over TENS for the acute relief of chronic shoulder and neck pain in adults.

Key Words: Electro-Acupuncture, Transcutaneous Electrical Nerve Stimulation, Crossover Trial, Neck Pain, Shoulder
Pain

INTRODUCTION men.2 Health surveys in Japan have found shoulder–neck to

be the most common physical complaint affecting 13% of
the population.3 Such complaints cause a significant disease
S houlder and neck complaints are extremely com-
mon in developed countries. A Swedish study of com-
bined neck and shoulder pain estimated a prevalence of 18%
burden, including chronic disability, diminished work pro-
ductivity, and decreased ability to perform activities of daily
in a random adult population.1 A large French study of a living.4–6 Shoulder–neck pain is an extremely broad term,
working population found the prevalence of chronic neck but careful studies of more precise descriptors have shown
and shoulder pain in women was 15%–18% and 8%–10% in that, by far, the most common form of pain is a dull muscle

1
Kyoto University Health Service, Kyoto, Japan.
2
Robert Wood Johnson Foundation Clinical Scholars Program, University of Michigan, Ann Arbor, Michigan.

97
98 YOSHIMIZU ET AL.

ache (pain that is like being stiff after exercise), affecting by TENS; or TENS followed by electro-acupuncture. Because
nearly 90% of patients with persistent pain.7 In Japan, the patients received two distinct active treatments making
single word katakori encompasses this quality of pain in the masking unfeasible, this study was conducted as an open trial.
neck and shoulder, which is essentially a myofascial pain
in a region extending from the posterior neck (C-1 level) Patients
through the shoulders and as low as the inferior scapula
Patients between the ages of 20 and 65 who self-identified
(T-7 level). Patients may describe the pain as stiffness,
(as confirmed by written history) as having chronic pain in
discomfort, or an ache.
the neck and/or shoulder region and had minimal experience
Patients in pain often seek complementary and alterna-
with acupuncture or TENS were eligible for inclusion.
tive medicine treatment, such as acupuncture. In 1994,
Patients were recruited from the university community,
1,000,000 Americans utilized acupuncture,8 which doubled
including both students and staff. The clinical definition
to > 2,000,000 by 2002; > 4% of Americans report lifetime
used for neck–shoulder pain (i.e., katakori) was ‘‘tightness
use.9 Among Japanese patients with chronic neck and
or stiffness in the shoulder and lower neck, especially the
shoulder pain, 59% of people are treated by acupuncturists
trapezius and semispinalis muscles.’’ Patients were ex-
and chiropractors, far more commonly than by Western
cluded if they met any of the following criteria: (1) con-
medical practitioners.3 Two such interventions that have
currently undergoing regular (one or more times a week)
shown some evidence of success include electro-acupuncture
treatment for neck–shoulder pain; (2) fear of acupuncture
and transcutaneous electrical nerve stimulation (TENS).10–13
techniques; (3) history of a neurologic condition; (4) history
Both modalities involve the conduction of low frequency
of a significant orthopedic condition; and (5) any other
electricity; in the former, the conduction is subcutaneous
factor that would impair involvement in a clinical trial (e.g.,
through typical acupuncture needles, while, in the latter, it is
inability to complete the follow-up). Baseline characteris-
through non-penetrating electrode pads. Nonetheless, high-
tics were collected for age, gender, history of myofascial
quality evidence of the efficacy of these treatments is scarce.
pain, related symptoms, and past medical history. Patients
Green and colleagues, writing for the Cochrane Collection,
were allocated to one of two groups using block randomi-
noted that few randomized controlled trials (RCTs) have
zation with a block size ranging from 2 to 6.20 Randomi-
been conducted on acupuncture for shoulder pain, those that
zation was performed by a researcher who was uninvolved
exist are methodologically diverse with poor descriptions
with the interventions and data analysis. This study was
of their interventions, and, thus, the researchers concluded
approved by the ethics committee of the Kyoto University
that there is a lack of evidence regarding whether acu-
Faculty of Medicine, and written informed consent was
puncture works or, conversely, is harmful.14 To the current
obtained from all patients before enrollment. A total of 90
authors’ knowledge, there has never been an RCT trial in
patients were enrolled, with a mean age of 34 years, and
the English-language literature comparing the effectiveness
females slightly outnumbered males.
of electro-acupuncture and TENS for shoulder and neck pain.
Trials that have compared electro-acupuncture to TENS have
Interventions
focused on related conditions such as lumbago;10–12,15,16 and
trials that have examined neck and shoulder pain have gen- Interventions were performed with patients in a prone
erally compared acupuncture to a placebo (sham).4,5,17,18 position in an examination room at the Kyoto University
Moreover, there has been a call for more RCTs that mirror Health Service. No special environmental interventions,
the more-realistic clinical situation in which a clinician must including aromatics, music, or lighting, were used. A single
choose between two treatment options, rather than one licensed acupuncturist (M.Y.), with 5 years of professional
versus nothing (i.e., placebo).16,19 experience and trained in both modalities, performed all
Thus, the aim of this clinical trial was to provide a treatments. For the electro-acupuncture treatment, four
practical, head-to-head comparison of the efficacy of elec- 0.20 · 50–mm stainless-steel, disposable acupuncture nee-
tro-acupuncture and TENS for adults who have chronic dles (Yamasho NEO, Nagahama-shi, Shiga-ken, Japan)
shoulder and neck pain or stiffness, using a randomized were inserted at four sites in the upper back and shoulder of
crossover trial design. each subject.18 Japanese-style acupuncture was used. This
style has two major distinctions from Chinese acupuncture:
first, a technique of acupuncture needle insertion called
kanshinhou utilizes a hollow tube through which the needle
MATERIALS AND METHODS
is guided; and second, Japanese acupuncture needles are
shorter (3–60 mm) and thinner (0.16–0.24 mm) than Chi-
Study Design
nese needles.
This study used a prospective, two-period, two-treatment The clinician first palpated for four acupoints associated
crossover design with patients randomized to one of the fol- with neck–shoulder pain and positioned in the trapezius: the
lowing two treatment sequences: electro-acupuncture followed left and right Jianjing (GB 21) and Jianwaishu (SI 14). For
EA AND TENS FOR SHOULDER AND NECK PAIN 99

electro-acupuncture, needles were then inserted into the Ah Four of the subscales in the SF-36 acute form (symptoms
Shi point within a 1-cm radius of these acupoints. Needles over the last week) were utilized: (1) role physical (4 items);
were inserted perpendicular to the skin, and not twirled. (2) bodily pain (2 items); (3) vitality (4 items); and (4)
Both acupuncture points and Ah Shi points have been shown mental health (5 items). These scores were transformed
to have a high degree (71%) of correspondence.21 Con- linearly to range from 0 (worst score) to 100 (best score).
sistent with previous research protocols and actual clinical Patients provided answers twice per intervention, once be-
practice, needles were inserted into muscle tissue to a depth fore treatment and once per week afterward. Safety of the
of between 10 and 15 mm.16,22 The needles were then treatment was assessed by report of adverse events, and by
connected to a low-frequency electrical generator (Techno monitoring of blood pressure (BP) and heart rate (HR) be-
Link Techtron DSP, Niigata-shi, Niigata-ken, Japan) set to fore and after each intervention.
an electrical frequency of 0.5–10 Hz, a current of 4-4.1 mA,
and a resistance of 500 O (ohms); then, the patients un- Statistical Analysis
derwent 15 minutes of stimulation. This duration was cho-
The average reduction in pain was calculated as the mean
sen based on standard clinical practice.23 Electrical strength
difference between the VAS score immediately before
was adjusted to the highest level that each patient could
treatment and those from immediately after through 6 days
tolerate comfortably (typically creating muscle contraction)
after treatment. A total of 90 subjects (45 for each group)
and readjusted after the first 5 minutes. For the TENS
were planned to be accrued into this study, which assured at
treatment, patients had four gel-type electrode pads placed
least 90% statistical power to detect a 4.5-mm difference in
at the same points (bilateral GB 21 and SI 14), using the
the average VAS score at a 5% significance level. The im-
same electrical generator set to an electrical frequency of 1–
provement of QoL was calculated as the difference between
1.5 kHz, a current of 60–63 mA, and a resistance of 500 O
pretreatment and post-treatment QoL scores. The effect on
(ohms). Duration of stimulation and adjustment were the
vital signs was also evaluated based on the pretreatment and
same as with electro-acupuncture.
post-treatment values. Analyses were performed on an in-
Participants received a single treatment session for each
tention-to-treat (ITT) basis.
intervention. There was a 2-week washout period before
Given that the main potential confounder in a crossover
the second randomized treatment but no washout prior to
trial is treatment-period interactions, that is, carryover ef-
the first. Any subject who developed an adverse reaction
fects,26 the carryover effect was first assessed using an un-
was treated appropriately and study treatment was stopped.
paired t-test applied to the individual sums of the first- and
Patients continued taking their routine medications for any
the second-period data. Treatment effects and period effects
chronic medical conditions (e.g., antihypertensives), but
were then assessed using an unpaired t test according to
were instructed to abstain from taking any new medications
standard analytical methods.27 In multivariate analyses,
(over-the-counter or prescription), including analgesics,
analyses of covariance were used for a crossover design by
during the study period.
the MIXED procedure of SAS, version 9, software (SAS
Institute, Cary, NC). When a treatment-period interaction
Outcome Measures term was not statistically significant, the interaction term
was deleted and the reduced model was used including
Previous articles have commented on the difficulty of
pretreatment value, gender, age, treatment, and period. All
establishing objective outcome measures for myofascial
tests of significance were two-sided and p < 0.05 was de-
pain syndromes, but from the patient’s perspective (which,
fined as significant.
after all, is the most clinically relevant), subjective func-
tional improvement is often measured.24 Thus, the primary
outcome for this study was pain relief as measured by a
RESULTS
100-mm visual analogue scale (VAS), ranging from 0 (‘‘no
pain at all’’) to 100 (‘‘worst neck and shoulder pain I have
Study Population
experienced’’). Subjects drew a hash mark at the point along
the line that best represented their pain level at the time Patient flow through the study is illustrated in Figure 1.
referenced in the question. Patients were asked to provide Ninety patients were enrolled in the study from September
VAS scores for a total of eight timepoints per intervention: 2005 through November 2006 and all completed the plan-
immediately before and after treatment and once daily on ned treatment. According to the randomization procedure,
the second through seventh day after treatment. To exclude 45 patients were allocated to each group. Subjects in group
recall bias, patients completed separate questionnaires at A received electro-acupuncture followed by TENS, while
each of these timepoints. those in group B received TENS followed by electro-
Secondary outcome variables included QoL measures acupuncture. Because of a technical error, two group A
and safety. QoL was assessed using a subset of 15 questions patients underwent the group B protocol, but were analyzed
derived from the Short Form (SF-36) Japanese, version 2.25 on an ITT basis.
100 YOSHIMIZU ET AL.

FIG. 1. Outline of patient enrollment and randomization. TENS, transcutaneous electrical stimulation.

Baseline characteristics of the study patients are shown electro-acupuncture). Electro-acupuncture then produced
in Table 1. The mean age was 34 years and females slightly sustained pain reduction on days 2 and 3 (VAS scores of
outnumbered males. Most patients complained of pain or 33 and 34, respectively), whereas TENS produced a more-
stiffness in both shoulders and in the neck, and these rapid decay in effect (VAS scores of 42 on days 2 and 3).
patients’ symptoms were chronic. Electro-acupuncture provided significantly more relief of
pain, compared to TENS on days 2 and 3 ( p = 0.001 and
Reduction in Pain p = 0.003, respectively).
In the standard crossover-design analyses, there was
Shoulder and neck pain over time by treatment is shown
neither a significant carryover effect ( p = 0.508) nor a pe-
in Figure 2. Patients had moderate pain at baseline (a VAS
riod effect ( p = 0.108) on pain reduction. Because there was
of 55 for TENS and a VAS of 56 for electro-acupuncture),
no evidence of systematic bias caused by order of treatment,
which substantially decreased immediately after treatment
pooled data from both periods were used to estimate treat-
in both treatment arms (VAS of 34 for both TENS and
ment effect. For the treatment effect, which was assessed
using the average reduction in pain from immediately after
Table 1. Baseline Characteristics of Patients treatment through day 7, electro-acupuncture showed a fur-
Group A Group B ther 5.3-mm improvement in VAS, score compared with
Electro–acupuncture TENS followed TENS ( p = 0.025). In an analysis of covariance, the treat-
followed by by Electro- ment-period interaction term was not significant ( p = 0.296).
Characteristics TENS n = 45 acupuncture n = 45 The pain-relief effect of electro-acupuncture remained sig-
nificantly greater ( p = 0.010) after adjustment for pretreat-
Age, yr – SD 33 – 11 34 – 12
ment VAS score, gender, age, and period. No covariates,
Female/male 25/20 27/18
Previous acupuncture
for shoulder/neck 1 (2%) 1 (2%)
symptom
for other complaints 4 (9%) 2 (4%)
Pain and stiffness location, no. (%)
Shoulder 14 (31%) 8 (18%)
Neck 1 (2%) 1 (2%)
Both 30 (67%) 37 (80%)
Duration of symptoms, no (%)
< 1 year 8 (18%) 7 (16%)
1–4 years 13 (28%) 11 (24%)
5–9 years 9 (20%) 11 (24%)
10–19 years 12 (27%) 12 (27%)
> 20 years 3 (7%) 4 (9%)
TENS, transcutaneous electrical nerve stimulation; yr, years; SD, FIG. 2. Shoulder and neck pain over time by treatment. VAS,
standard deviation. visual analogue scale; TENS, transcutaneous electrical stimulation.
EA AND TENS FOR SHOULDER AND NECK PAIN 101

Table 2. Quality of Life Measurements Before and After Treatment

Electro-acupuncture TENS

Subscale of SF-36 Before After Before After p-Value*

Role physical 83.3 – 19.2 89.0 – 14.8 84.2 – 19.4 86.1 – 17.4 0.129
Bodily pain 67.5 – 23.0 72.5 – 21.4 66.7 – 23.2 68.4 – 20.7 0.314
Vitality 54.2 – 21.1 61.5 – 18.1 56.9 – 19.5 58.6 – 21.7 0.005
Mental health 70.9 – 17.6 72.3 – 17.3 70.3 – 20.5 70.6 – 20.2 0.572
SF-36, Short-Form–36; TENS, transcutaneous electrical nerve stimulation.
*Comparison was made for the pre- and post-treatment difference between electroacupuncture and TENS.

except pretreatment VAS scores, were significantly corre- pretreatment value in electroa-cupuncture, probably be-
lated with pain reduction. cause of a fear of pricking pain, decreased to the same level
as TENS after treatment, yielding a small, but significant
QoL treatment-related change ( p = 0.021). In the analysis of
covariance, electro-acupuncture was associated with a
QoL measures showed that vitality was similar pretreat-
significantly larger change in HR ( p = 0.021) than TENS
ment (54.2 for electro-acupuncture and 56.9 for TENS), but
after adjustment for pretreatment score, gender, age, and
that QoL only improved post-treatment for electro-
period. There were no such differences in systolic or dia-
acupuncture (61.5) and not for TENS (56.6). In the analysis
stolic BP between electro-acupuncture and TENS in the
of covariance, electro-acupuncture produced a significantly
analysis of covariance. The treatment-period interaction
greater improvement in vitality ( p = 0.005) than TENS did
term was not significant in either of these analyses.
after adjustment for pretreatment score, gender, age, and
period (Table 2). For role physical, bodily pain, and mental
health subscales, there were no significant differences in
DISCUSSION
improvement between electro-acupuncture and TENS. The
treatment-period interaction term was not significant in
To the authors’ knowledge, this is the first randomized
these analyses. Furthermore, there were no significant car-
trial that compared electro-acupuncture and TENS for
ryover effects in the role physical, bodily pain, vitality, and
shoulder and neck pain. The results suggest that both
mental health subscales of the SF-36 ( p = 0.741, 0.646,
electro-acupuncture and TENS are effective short-term
0.273, and 0.072, respectively).
therapies for chronic shoulder and neck pain, but electro-
acupuncture is preferable because its pain-relieving effect
Safety
is more durable. Specifically, the superiority of electro-
No serious adverse events were reported. BP and HR were acupuncture continued for at least 2 days after treatment
stable for both electroacupuncture and TENS (Table 3). and then gradually attenuated.
There were no significant carryover effects in systolic BP, The effect size of electro-acupuncture, while not large,
diastolic BP, and HR ( p = 0.213, 0.189, and 0.825, re- was clinically significant. Specifically, electro-acupuncture
spectively). Systolic and diastolic BP readings were sim- produced a 41% reduction in pain 1 day after treatment,
ilar between electro-acupuncture and TENS, and no whereas TENS produced only a 24% reduction at that same
significant treatment effects ( p = 0.307 and 0.312, respec- timepoint. For patients with chronic pain, a 16% benefit for
tively) were found. In terms of HR, a slightly increased a treatment modality is meaningful and similar to results

Table 3. Vital Signs Before and After Treatment

Electro-acupuncture TENS

Vital sign Before After Before After p-Value*

Blood pressure
Systolic 109.4 – 16.4 109.0 – 14.9 110.0 – 14.5 108.6 – 14.4 0.307
Diastolic 66.4 – 13.7 67.5 – 11.8 66.2 – 13.1 66.0 – 13.7 0.312
Heart rate 66.2 – 9.8 62.6 – 7.9 64.9 – 8.7 62.5 – 8.0 0.021
TENS, transcutaneous electrical nerve stimulation.
*Comparison was made for pre- and post-treatment difference between electroacupuncture and TENS.
102 YOSHIMIZU ET AL.

found in other studies, such as in acupuncture for low-back subjects improved merely because of an anticipatory ef-
pain.28 Improvement in vitality was more modest, at 13% fect, it would be quite odd for this delayed peak in the
for electro-acupuncture versus - 1% for TENS; we suspect effectiveness of acupuncture, but it is consistent with
this was the result of post-treatment measurement not acupuncturists’ clinical experience. In short, the authors
occurring until 1 week later. suggest that the relief from TENS served as an effective
The relative simplicity and uniformity of the electro- control intervention. Second, both interventions were gi-
acupuncture treatment protocol makes it amendable to both ven equal consideration with equal one-on-one therapeutic
clinical application and reproducibility. Only four needle care, which should have equalized any psychological
locations, standardized to easily identifiable anatomical benefits intrinsic to undergoing treatment. The authors felt
landmarks on the easily accessible trapezius muscle, with that it was not feasible to create a believable placebo
just 15-minute electrical stimulation was enough to produce treatment group with electro-acupuncture. Moving needle
both a clinically and statistically significant difference. placement away from acupoints, though used sometimes in
Physicians and researchers have noted that the efficacy of sham manual acupuncture, was also felt to be too similar to
acupuncture may depend on the individual skill of the real treatment because the larger area of effect provided by
practitioner, and interpatient variation in placement of electrical stimulation.
needles is widely regarded by acupuncturists as essential to This study has some other noteworthy limitations. First,
treatment. Electro-acupuncture requires less technical ex- because it did not include a placebo control, it was not
pertise than manual acupuncture, because even a deviation possible to evaluate the magnitude of change relative to no
off an acupoint is partially accommodated for by the re- treatment at all in this study population. Second, lack of
gional effect of the electrical current. With relatively limited blinding limited the internal validity of the study. Third,
training, even non-acupuncturist clinicians working in pri- treatment was limited to a single session for each modality,
mary care or pain clinics could be capable of performing the whereas in actual clinical practice most patients would un-
electroacupuncture treatment protocol used in this study. dergo repeated treatments. Studies with longer treatment
Strengths of this study included its randomized design, and follow-up periods to evaluate how long-lasting a benefit
perfect follow-up rate, lack of interoperator bias, and rela- can be achieved are warranted.29,30 Fourth, outcomes re-
tively larger sample size (especially when considering the flected subjective data, based on a VAS and the SF-36. In
effective doubling of data with a crossover design), com- future experiments, adding more physiological measures as
pared to similar studies. A crossover design was well-suited well as use of validated tools, such as a pressure alg-
to this trial for two reasons. One, treatment for myofascial ometer,29,30 would complement subjective measures.
neck and shoulder pain temporarily alleviates but does not
cure the pain, which is key to achieving a washout between
interventions.26,27 Second, this study uniquely allowed pa- CONCLUSIONS
tients to serve as their own controls, which is useful when
treatment responses and subjective assessments of im- Taken together, these results provide preliminary evidence
provement have wide individual variations. supporting the use of electro-acupuncture for relief of neck
Another major strength of this study is its clinical appli- and shoulder pain. It is notable that a single, simple, and short
cability. Designed to be a practical comparison, this study form of electro-acupuncture treatment can make a significant
was a head-to-head comparison of two reasonable, compa- reduction of chronic symptoms, compared to TENS treat-
rable therapeutic options used in clinical practice. Despite ment. More research, including longitudinal follow-up, a
neck and shoulder complaints being among the most preva- placebo treatment arm, and other outcome measures are es-
lent in primary care, few high-quality studies have compared sential to strengthen and validate these findings.
the results of the many treatment choices available. By sug-
gesting the superiority of an acupuncture technique to a
technique similar in all ways, except for use of needling, this ACKNOWLEDGMENTS
study helps fill in the gap of knowledge necessary for clini-
cians to make good, evidence-based treatment decisions. Dr. Teo wishes to acknowledge support for this study
Because this was an open trial, a placebo effect could provided by grants from the Robert Wood Johnson Foun-
have accounted for observed differences. However, the dation Clinical Scholars program and the University of
authors find this unlikely for two reasons. First, the pain California, San Francisco School of Medicine Office of
trend observed in this study argues against a simple pla- International Programs.
cebo effect. TENS provided significant immediate relief;
indeed, pain relief from TENS was essentially identical
to electro-acupuncture immediately after treatment. This DISCLOSURE STATEMENT
trend changed, however, a day after treatment when elec-
tro-acupuncture showed that it was more effective. If No competing financial interests exist.
EA AND TENS FOR SHOULDER AND NECK PAIN 103

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