Open Access Protocol

Electroacupuncture to alleviate

BMJ Open: first published as 10.1136/bmjopen-2016-015286 on 4 August 2017. Downloaded from [Link] on 20 May 2019 by guest. Protected by copyright.
postoperative pain after a laparoscopic
appendectomy: study protocol for a
three-arm, randomised, controlled trial
Seunghoon Lee,1 Dongwoo Nam,1,2 Minsoo Kwon,1 Won Seo Park,3,4
Sun Jin Park3,4

To cite: Lee S, Nam D, Kwon M, Abstract

et al. Electroacupuncture Strengths and limitations of this study
Background  The purpose of this study is to evaluate
to alleviate postoperative the efficacy and safety of electroacupuncture (EA) for
pain after a laparoscopic ►► This study comprises real electroacupuncture with
postoperative pain after laparoscopic appendectomy
appendectomy: study protocol sham electroacupuncture using non-penetrating
compared with sham electroacupuncture (SEA) and no
for a three-arm, randomised, placebo needles to reduce performance bias.
controlled trial. BMJ Open acupuncture treatment.
►► The electroacupuncture regimen was already used
2017;7:e015286. doi:10.1136/ Methods and analysis  This study is a protocol for a
and validated in the clinic.
bmjopen-2016-015286 three-arm, randomised, patient-assessor-blinded (to
►► Electroacupuncture treatment is difficult to blind
the type of acupuncture treatment), controlled, parallel
►► Prepublication history for practitioners.
trial. 138 participants diagnosed with appendicitis
this paper is available online.
and scheduled for laparoscopic appendectomy will be
To view these files, please visit
the journal online ([Link] randomly assigned to the EA group (n=46), SEA group
scarring and preserved immune func-
org/​10.​1136/​bmjopen-​2016-​ (n=46) or control group (n=46). The EA group will receive
acupuncture treatment at both regional and distal tion.1 2 Among various factors, pain is the most
015286).
acupuncture points with electrostimulation. The SEA important independent predictor of recovery
Received 23 November 2016 group will receive sham acupuncture treatment with mock time after laparoscopic surgery.3 Despite
Revised 13 June 2017 electrostimulation. Both EA and SEA groups will receive small incision size, laparoscopic surgery still
Accepted 13 June 2017 a total of four treatments 1 hour preoperative, 1 hour results in substantial postoperative pain in
postoperative and during the morning and afternoon the the incision region (somatic pain). Moreover,
day after surgery with the same routine postoperative inflation with carbon dioxide during the lapa-
pain control. The control group will receive only routine roscopic procedure induces shoulder pain
postoperative pain control. The primary outcome is the due to irritation of the phrenic nerve, which
11-point Pain Intensity Numerical Rating Scale (PI-NRS) at
is referred to as visceral pain.4
24 hours after surgery. The secondary outcomes are the
Multimodal approaches are beneficial for
PI-NRS, analgesic consumption, opioid-related side effects,
time to first passing flatus, quality of life and adverse treating postoperative pain because there
events evaluated 6, 12, 24 and 36 hours and 7 days after are multiple mechanisms of pain after lapa-
surgery. roscopic surgery.3 Opioid analgesics are
Ethics and dissemination  The study was planned in generally used to control pain with rapid
accordance with the Helsinki Declaration and the Korean onset of action.5 However, side effects asso-
1
Department of Acupuncture and Good Clinical Practice Guidelines to protect the participants ciated with opioids such as nausea/vomiting,
Moxibustion Medicine, Kyung and was approved by the institutional review board (IRB) of pruritus and reduction in bowel motility
Hee University Korean Medicine Kyung Hee University Medical Center (KMC IRB-1427–02).
Hospital, Seoul, South Korea
(leading to ileus and constipation) may lead
2
The results will be disseminated in peer-reviewed journals to a delayed hospital discharge.6 Although
Department of Acupuncture and
and presented at international conferences.
Moxibustion, College of Korean other modalities, such as non-steroidal
Trial registration number  Clinical Research Information
Medicine, Kyung Hee University, anti-inflammatory drugs, cyclooxygenase-2
Seoul, South Korea Service (KCT0001328).
3
inhibitors and local anaesthetics, are also
Department of Surgery, Kyung
Hee University Hospital, Seoul,
used for postoperative pain, patients who
South Korea have undergone laparoscopic surgery are
4
Department of Surgery, Kyung Introduction generally unsatisfied with pain control and
Hee University School of Laparoscopic surgery is a general surgical approximately 30%–40% patients suffer from
Medicine, Seoul, South Korea technique with advantages over traditional moderate pain after hospital discharge.7
Correspondence to open surgery such as reduced postoperative Electroacupuncture (EA) shows the
Professor Sun Jin Park; pain, shorter hospital stay, faster recovery potential to reduce postoperative pain
​gsdrpark@​naver.​com time, decreased postoperative ileus, reduced as an adjuvant therapy to conventional

Lee S, et al. BMJ Open 2017;7:e015286. doi:10.1136/bmjopen-2016-015286 1

Open Access

anaesthetics. Several clinical trials have shown that preop- acupuncture treatment 1 hour before the scheduled lapa-

BMJ Open: first published as 10.1136/bmjopen-2016-015286 on 4 August 2017. Downloaded from [Link] on 20 May 2019 by guest. Protected by copyright.
erative or postoperative EA reduced postoperative pain roscopic surgery. The postoperative pain management of
and analgesic consumption with no significant adverse all patients will be performed according to the manual
effects.8–11 However, based on a recent systematic review, of the Department of Surgery of the Kyung Hee Univer-
there is still insufficient evidence to conclude that EA is sity Medical Center. The patients assigned to the EA or
an effective method for controlling postoperative pain in SEA groups will receive acupuncture treatments again
surgery due to methodological flaws in the studies that 1 hour after surgery and the morning and afternoon of
have been performed. Moreover, previous acupuncture the following day. Patients will be discharged on 2 days
trials have mostly focused on postoperative pain after after surgery, and follow-up visits will be scheduled on 7
open surgery12 or orthopaedic surgery such as total knee (±3) days after surgery (figure 1).
arthroplasty13–15 or back surgery.16 For this reason, despite
Participants
the potential benefits of EA for postoperative pain, the
Inclusion criteria
efficacy and safety of EA for laparoscopic surgery remains
Participants who meet the following conditions will be
to be examined. We aim to evaluate the effects of EA on
included: (1) men or women aged 19 to 65 years, (2)
postoperative pain after laparoscopic appendectomy as a
diagnosed with appendicitis and scheduled for laparo-
basic, common and representative laparoscopic surgery.
scopic appendectomy and (3) agreement via written
informed consent after being provided with an expla-
nation regarding the purpose and characteristics of this
Methods/design study.
Objective
The aim of this study is to assess the efficacy and safety Exclusion criteria
of EA for postoperative pain through pain intensity, anal- Participants who have experienced or have one or more
gesic consumption, opioid-related side effects, time to of the following conditions will be excluded: (1) accom-
first passing flatus, quality of life and adverse events after panying complications such as perforated appendicitis
laparoscopic appendectomy compared with sham elec- or diffuse peritonitis, (2) development of a surgical site
troacupuncture (SEA) and no acupuncture treatment. infection during the hospital stay, (3) regular use of pain-
killers or use of other pain relieving medicine on the
Design and setting day of the surgery, (4) cardiovascular disorders such as
This study is a single-centre, three-arm, equal randomised, arrhythmia or use of a pacemaker, (5) received acupunc-
patient-blinded and assessor-blinded (to the type of ture treatment within 6 weeks prior to surgery, (6) known
acupuncture treatment), parallel-group, clinical trial hypersensitive reaction to acupuncture treatment or the
conducted in Korea. inability to cooperate with the acupuncture procedure,
Recruitment period (7) pregnant, breast feeding or expecting a pregnancy
The participants will be recruited from the Kyung Hee during the study period and (8) others that have been
University Medical Center in Seoul, Korea. Recruitment deemed inadequate for participation by research inves-
is expected to span from April 2015 to March 2017. tigators.
Methods of recruitment Randomisation and allocation concealment
A total of 138 participants diagnosed with appendicitis Enrolled participants will be randomly assigned to EA,
and scheduled for laparoscopic appendectomy through SEA or control group ([Link]). An independent, blinded
the outpatient department or emergency room will be statistician will generate the block randomisation scheme.
recruited at the Department of Surgery of Kyung Hee The table will be managed by another independent
University Medical Center. researcher who is not involved in the recruitment,
acupuncture treatment or assessment. The CRC will send
Study setting
the assignment information to the researcher who will
Oral and written consent will be obtained from patients
conduct random allocation, then the researcher will only
who are potentially eligible for the study before surgery.
provide assignment information to the doctors of Korean
A researcher will explain the two types of EA treatments
medicine (DKMs) that perform the acupuncture treat-
as ‘classical EA, typically used in Korean medicine clinics’
ment. To ensure allocation concealment, the allocated
and ‘non-classical EA, rarely used in Korean medicine
group information will be recorded in an allocation log
clinics’.17 After a patient voluntarily consents to the
by the researcher and will not be opened until the data
study, a researcher will screen whether the patient can
are locked.
participate in the study. If the patient satisfies the inclu-
sion/exclusion criteria, a clinical research coordinator Blinding
(CRC) will contact an independent researcher who The participants will be blinded to the type of acupunc-
has the random number table, and the patient will be ture treatment and the assessor, data managers,
randomly allocated into one of three groups (the EA, statisticians and study monitors will be blinded to the
SEA or control group) at a [Link] allocation ratio. Only the allocation. All participants who receive acupuncture will
patients assigned to the EA or SEA group will receive the be treated using the Park sham device (PSD; Acuprime,

2 Lee S, et al. BMJ Open 2017;7:e015286. doi:10.1136/bmjopen-2016-015286

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BMJ Open: first published as 10.1136/bmjopen-2016-015286 on 4 August 2017. Downloaded from [Link] on 20 May 2019 by guest. Protected by copyright.
Figure 1  Flow chart of study process. EA, electroacupuncture; SEA, sham electroacupuncture.

Exeter, UK) regardless of what group they are included needling components,18 and both groups will be given
in. Moreover, mock EA will be provided with the same the same postoperative analgesics in accordance with the
pulse sound and lamp light as real EA, so the participants predefined protocol and SOPs. This information will be
will not be able to predict the allocated group based given to the practitioners during workshops before the
on the appearance of the acupuncture treatment. The study begins to ensure standardisation of the treatments.
blinding will be maintained until the data are locked. For A Park sham needle guide tube19 20 will be used for both
blinding evaluation, allocation guessing will be assessed EA and SEA groups to ensure that the patients remain
immediately after the final treatment. Practitioners unaware of the differences between the two acupunc-
and assessors will be instructed to treat the participants ture treatments. This will ensure that the patients do
according to predefined standard operating procedures not discern any differences between the individualised,
(SOPs) during the trial to maintain blinding. real acupuncture and sham acupuncture treatments,
Intervention although the penetration of the needles will vary between
EA treatment will be conducted by DKMs with more than the two groups.
6 years of Korean medicine college education and at least Surgical procedure
2 years of clinical experience. A total of four acupuncture The surgical department is part of a tertiary teaching
treatments will be performed in the EA and SEA groups. hospital, in which 12 surgeons and 7 residents partici-
One hour preoperative and 1 hour postoperative treat- pate. Laparoscopic appendectomies are performed by
ments will be performed on the day of the surgery (day surgeons or residents under the supervision of a surgeon.
0). On the day after surgery (day 1), one treatment will The operation is performed under general anaesthesia
be carried out in the morning (08:00–12:00) and another with the patient in a supine position. A 12 mm trocar for
in the afternoon (13:00–17:00) with at least 4 hours the camera is inserted just below the umbilicus. Two addi-
between treatments. Each acupuncture treatment will tional 5 mm trocars are inserted in the suprapubic area
be performed after the acupuncture points are sterilised and right or left lower abdomen. The surgical procedure is
with a disposable ethyl alcohol swab and the acupuncture performed using standard laparoscopic instruments and
needles will be retained for 30 min. Both EA and SEA are in a usual manner including dividing the mesoappendix,
performed under the same conditions, except for the ligating the appendix and removing the specimen using

Lee S, et al. BMJ Open 2017;7:e015286. doi:10.1136/bmjopen-2016-015286 3

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is indistinguishable from a real acupuncture needle, but

BMJ Open: first published as 10.1136/bmjopen-2016-015286 on 4 August 2017. Downloaded from [Link] on 20 May 2019 by guest. Protected by copyright.
it does not penetrate the skin.
For local abdomen points, SEA treatment will be
performed on the abdomen region (two sites; 3 cm above
and 2 cm lateral to the umbilicus). For distal points, both
arms (two sites per arm; 5 cm and 7 cm below the midpoint
of the cubital crease) and both legs (two sites; 7 cm above
the medial malleolus and 0.3 cm lateral to the tibia and
9 cm above the medial malleolus and 0.3 cm lateral to the
tibia) will be treated using the PSD and sham acupunc-
ture needles creating a false movement that is similar to
the twisting manoeuvre of acupuncture. No deqi sensa-
tion will be induced. To simulate electrical stimulation,
Figure 2  Acupuncture points of treatment. (A) The hands an electrical stimulating device will be connected to the
will be treated at two standard acupuncture points (LI4 needles, but no electrical current will be delivered. The
and PC6). (B) The legs will be treated at four standard patient will see the light and hear the sound of the pulse
acupuncture points (ST36, GB34, SP6 and LR3). (C) The generator equal to those of the EA group. The rest of the
abdomen will be treated four ashi points located within a procedure is equal to that of EA group.
diameter of 5 cm from the incision site. (A written consent
for the picture was obtained from the pictured subject. Postoperative pain control
Photograph by Seunghoon Lee). All participants will receive standard postoperative pain
control in accordance with the manual of the Depart-
ment of Surgery at Kyung Hee University Medical Center.
a pouch. The 12 mm port site is closed using 2-0 Vicryl The standard postoperative pain control procedure is as
sutures and the skin incision is closed with subcuticular follows.
sutures. Nefopam hydrochloride (ACUPAN INJ 20 mg/2 mL;
Electroacupuncture treatment Pharmbio Korea, Chungju, South Korea) and Ketorolac
A total of four acupuncture sessions will be performed tromethamine (KETOCIN INJ 30 mg/mL; Myungmoon
using 0.25×40 mm disposable sterile acupuncture needles Pharm., Seoul, South Korea) will be routinely used to
(Dong Bang Acupuncture, Chungnam, South Korea). control postoperative pain. Nefopam hydrochloride
After penetration, deqi sensation will be induced using 100 mg and Ketorolac tromethamine 60 mg will be mixed
reinforcing-reducing techniques such as rotating and and diluted in 500 mL dextrose and given intravenously
lifting–thrusting methods. An EA device (Partner-1; ITC, twice during the hospitalisation period.
Daejeon, South Korea) will be used to apply 2/120 Hz If additional pain control is needed, tramadol hydro-
(acupuncture points: bilateral ST36, GB34, LI4, PC6, SP6, chloride (TRAMADOL HCL INJ 50 mg/L; Shin Poong
LR3) and 120 Hz (acupuncture points: four ashi points Pharm, Seoul, South Korea) 50 mg (intramuscular or
located within a diameter of 5 cm from the incision site) at intravenous injection) will be administered no more than
80% of the maximum intensity that the patient can endure. once every 4–5 hours, and the maximum dose of tramadol
Acupuncture point selection (including local abdomen HCl will not exceed 400 mg per day. The total amount of
and distal points) and frequency of electrical stimulation tramadol use will be recorded by a blinded researcher.
were based on traditional acupuncture theory and clinical
Outcome measures
experience by clinicians. The practitioner will regulate the
The details of the outcome measures and time points are
intensity based on the degree of the twitching of muscles or
shown in table 1.
by request from the subject, and only one adjustment will
be allowed during treatment. In both acupuncture groups, Primary outcome
an infrared lamp will be applied to keep the abdominal The primary outcome is pain intensity in the abdomen
area of the patients warm during treatment (figure 2). region using the 11-point Pain Intensity Numerical
Rating Scale (PI-NRS; 0=no pain and 10=worst possible
Sham electroacupuncture treatment
pain, 11-point Likert scale) 24 hours after surgery. The
PSD will be used for SEA treatment. It is a validated
PI-NRS has been widely used to assess all kinds of pain,
sham acupuncture device that consists of two tubes
and recently it has been validated for measuring postop-
and a sham acupuncture needle.20 The ‘Guide tube’
erative pain intensity.21 The patients are asked to choose
supports the needle as it penetrates the skin vertically.
a value that best represents the intensity of pain that they
A larger tube called the ‘Park tube’ is attached to the
are experiencing at the moment. A written form with
ring base and allows the ‘Guide tube’ to move along the
numeric values from 0 to 10 is frequently used as well.
‘Park tube.’ A silicon base is attached to the skin using
In a previous study, a threshold of NRS ≥4 was the cut-off
double-sided tape.19 A sham acupuncture needle of PSD
value for distinguishing mild and moderate-to-severe
postoperative pain intensity during the first 24 hours after

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The opioid-related side effects such as nausea, vomiting,

Table 1  Schedule for treatment and outcome

BMJ Open: first published as 10.1136/bmjopen-2016-015286 on 4 August 2017. Downloaded from [Link] on 20 May 2019 by guest. Protected by copyright.
measurements itching and ileus will be measured by PI-NRS at 6, 12, 24,
36 hours and 7 days after surgery.
Period S T F
Time-to-first-passing flutus first after surgery will be
Day 0 0 1 2 7 checked.
Informed consent ● The EuroQol Five Dimensions Questionnaire (EQ-5D)
Demographic characteristics ●
will be used to evaluate the quality of life of a patient with
postoperative pain at 24 hours and 7 days after surgery.
Inclusion/exclusion criteria ● EQ-5D is a standardised tool used to measure health
Conformity assessment ● outcomes that includes generic questions about quality
Random allocation ● of life as it relates to personal health status. EQ-5D is
regarded as one of the most appropriate instruments to
Acupuncture treatment ○ ○
evaluate patient quality of life after surgery.25 We will use
Laparoscopic surgery ● the Korean version of the EQ-5D.26
Efficacy assessments
Safety and adverse events
 PI-NRS ● ● ● ● The practitioners will be instructed to record all unex-
 Consumption of analgesics ● ● ● pected and unintended responses that are not necessarily
 Opioid-related side effects ● ● ● related to the EA treatment on an adverse event report
form. Pain, bruising, bleeding, dizziness, anxiety and
 Time to first passing flatus ● ● ●
infection are some of the adverse events known to be
 EQ-5D ● ● ● ● related to EA treatments.27 A causal relationship between
Blinding test ○ the EA treatment and adverse events will be assessed using
Safety assessment ● ● ● ● a 6-point scale (1=definitely related, 2=probably related,
3=possibly related, 4=probably not related, 5=definitely
Day 0: surgery day; day 1: 1 day after surgery; day 2: 2 days after not related and 6=unknown), and the severity of the
surgery;day 7: 7 days after surgery (±3 days).
Acupuncture treatment will be conducted two times at day
adverse events will be scored using a 4-point scale (1=mild,
1. Efficacy assessments will be conducted 6, 12, 24, 36 and 2=moderate, 3=severe and 4=extremely severe).
72 hours after surgery during the treatment period.
● All groups.
Blinding assessment
○ Both the electroacupuncture and sham acupuncture groups. At the end of treatment, the patients will guess to which
EQ-5D, EuroQol Five Dimensions Questionnaire; F, follow-up group they were allocated: real or sham EA treatment.
visit; PI-NRS, 11-point Pain Intensity Numerical Rating Scale; S, The patients will choose one of the following three
screening visit; T, treatment period.  options based on their personal feelings about the treat-
ment they received: ‘classical acupuncture typically used
in Korean medicine clinics’, ‘non-classical acupuncture,
surgery. This value was confirmed using four different rarely used in Korean medicine clinics’ or ‘do not know’.
methodological approaches.22
In cases where additional pain medicine is adminis- Sample size calculation
tered, the assessors will be instructed to evaluate pain The sample size was calculated based on the mean and SD
intensity 2 hours after drug administration. of NRS from the previous study.9 The mean and SD of the
EA group (2.1 and 1.2) and those of the control group
Secondary outcomes (3.2 and 1.8) were used as the expected values in our
The pain intensity of the abdomen region at rest, coughing study. With a two-sided significance level of 5% (α=0.05)
and overall average will be measured by the PI-NRS at 6, and 80% power (1-β=0.8), 32 patients are required per
12, and 36 hours and 7 days after surgery. Moreover, lapa- treatment group. Considering a 30% dropout rate, a total
roscopy-induced shoulder pain will also be measured 6, of 138 patients are needed for the study. The software
12, 24, 36 hours and 7 days after surgery. We predefined PASS V.12 (NCSS, Kaysville, Utah, USA) was used for the
the type of improvement for clinical relevance as follows: calculation.
a 30% reduction in PI-NRS is ‘minimal improvement’; a Statistical analysis
70% reduction in PI-NRS is ‘much improvement’ and a Analysis populations
90% reduction in PI-NRS is ‘complete improvement.’23 24 The analysis set will include a full-analysis set (FAS),
Therefore, in this trial, both the absolute and relative per-protocol (PP) set and safety set. The safety set will
score changes will be used to analyse the clinical rele- consist of all randomised participants who received
vance. laparoscopic surgery or at least one EA, SEA or no
The total amount of analgesic consumption used will acupuncture (NA) treatment during the course of the
be evaluated by an independent researcher blinded to study. The FAS population will consist of all partici-
the allocation at 6, 12, 24 and 36 hours and 7 days after pants in the safety population who are evaluable for the
surgery. primary outcome. The FAS population will be used as the

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primary population for all efficacy analyses. The PP popu- measures will be performed for repeated measure

BMJ Open: first published as 10.1136/bmjopen-2016-015286 on 4 August 2017. Downloaded from [Link] on 20 May 2019 by guest. Protected by copyright.
lation will consist of the all participants included in the outcomes.
FAS population, but will exclude the following: (1) partic- Data and safety monitoring
ipants violating any inclusion/exclusion criterion and To ensure the quality of the data is in accordance with
(2) participants with major protocol violations (eg, poor the predetermined protocol and SOPs, regular moni-
compliance (<75%  treatment compliance), incorrect toring will be carried out. Monitors will be blinded to
completion of study); only sufficiently serious violations the allocation and will examine whether the recruitment
will warrant exclusion. procedures and data recording followed the protocol in
General statistical methodology the case report forms. In case modifications in the study
Descriptive summaries will be provided where appro- methods are necessary, such as changes to the eligibility
priate for each of the primary and secondary outcomes. criteria, treatment regimens or duration of follow-up,
In general, summaries will be presented by the partici- the principal investigator may discuss the issue with inde-
pant population and by treatment groups and/or overall. pendent researchers and statisticians. In case of severe
In general, continuous variable summaries will include adverse events or crucial issues, the principal investigator
the number of participant, mean, SD, median, minimum will determine whether the events are acceptable or
and maximum and first and third quartiles, as appro- whether it is necessary to change or terminate the trial.
priate. Categorical variable summaries will include the
Ethics and dissemination
frequency and percentage of participants who are in the
The study was planned in accordance with the Helsinki
particular category.
Declaration and the Korean Good Clinical Practice Guide-
The last observation carried forward method will
lines to protect the participants and was approved by the
be used to process the missing data for the primary
institutional review board (IRB) of Kyung Hee University
outcome. All hypothesis testing will be carried out at the
Medical Center (KMC IRB-1427–02). The participants will
5% (two-sided) significance level. All secondary outcomes
be informed on the potential benefits, risks, alternatives
are exploratory and therefore no adjustment for multiple
and responsibilities of the study by the researchers during
testing will be applied.
the consent process. To avoid potential adverse events,
Statistical software if there is a patient whom the practitioner considers
Data manipulation, statistical summaries and statistical unsuitable for EA treatment due to an abnormal health
analyses will be performed using SAS V.9.4 by an inde- condition such as severe pain or vomiting, the treatment
pendent biostatistician. Some analysis may be carried out will be rescheduled within 2 hours at the practitioner’s
in R V.3.2.0 or higher ([Link] discretion. The findings will be disseminated in peer-re-
Analysis of demographics and other baseline characteristics viewed journals and conference presentations.
Comparisons of demographic and other baseline charac-
teristics among the three groups will be made using the
χ2 test, Fisher’s exact test, analysis of variance or Krus- Discussion
kal-Wallis test, according to the type of variable. The purpose of this study is to evaluate the efficacy and
safety of EA for postoperative pain after laparoscopic
Primary efficacy outcome analysis appendectomy compared with SEA and no acupunc-
For a confirmatory analysis, an a priori-ordered two-sided ture treatment. When planning an EA study, timing of
null hypothesis will be tested using the Student’s t-test treatment, treatment points and frequency of electric
or Wilcoxon rank sum test in a stepwise fashion with a stimulation should all be carefully considered as these can
significance level of 5%.9 28 First, whether EA was more affect the outcomes of EA. In several EA trials for post-
efficacious than no acupuncture treatment in reducing operative pain, it is likely that the results varied because
postoperative pain 24 hours after laparoscopic surgery will of heterogeneity in the protocol. For this reason, we
be investigated and second (only if the first null hypoth- established a regimented EA protocol based on previous
esis was rejected), whether EA was more efficacious than research and our clinical experience. This protocol has
SA will be investigated. All efficacy analyses will use the been tested and optimised at the Kyung Hee University
FAS and the PP population. Medical Center.
Secondary outcome analysis While acupuncture is usually applied after the onset
The secondary outcomes will be evaluated using a of pain in most pain-related conditions such as low
Student’s t-test or Wilcoxon rank sum test for continuous back pain, knee pain or headache, acupuncture can be
data or χ2 test or Fisher’s exact test for categorical data. performed before, during or after surgery to alleviate
These results will be compared with an adjusted result postoperative pain. Most preoperative and postoperative
using an analysis of covariance with the baseline measure- acupuncture trials have shown to be effective for reducing
ments (eg, PI-NRS before surgery, type of appendicitis postoperative pain and analgesic consumption. However,
(suppurative, exudative, gangrenous or perforated) and intraoperative EA has shown little to no effect on anal-
age) as a covariate, the treatment group as a fixed effect. gesic consumption, though only a few studies have been
Multivariate analysis using a mixed model for repeated conducted. Adding the fact that it is realistically difficult

6 Lee S, et al. BMJ Open 2017;7:e015286. doi:10.1136/bmjopen-2016-015286

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to conduct EA during surgery, we planned to perform EA Provenance and peer review  Not commissioned; externally peer reviewed.

BMJ Open: first published as 10.1136/bmjopen-2016-015286 on 4 August 2017. Downloaded from [Link] on 20 May 2019 by guest. Protected by copyright.
treatments only before and after surgery. Data sharing statement  We will share the data after the trial is finished. The full
Previous studies have used various acupuncture points data set will be available by an author contact when this trial is completed and
published.
that include distal points such as ST36 and LI4,8 9 11 29
local points around the incision region29 or a combina- Open Access  This is an Open Access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which
tion of points.10 30 There have not yet been any studies permits others to distribute, remix, adapt, build upon this work non-commercially,
that directly compare the effects of distal and local points, and license their derivative works on different terms, provided the original work is
but one study29 reported that electrical nerve stimulation properly cited and the use is non-commercial. See: [Link]
significantly reduced postoperative pain in both local and licenses/​by-​nc/​4.​0/
distal point treatment groups. Some studies used only © Article author(s) (or their employer(s) unless otherwise stated in the text of the
distal points due to fear of potential adverse events by article) 2017. All rights reserved. No commercial use is permitted unless otherwise
expressly granted.
direct electrical stimulation around the incision site, but
there has not been any reports of adverse events such as
increased pain or infection of the surgical site in studies
that have applied electrical stimulation directly near the References
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There is still a lot of debate on the optimal frequency cholecystectomy--a review of the current options. Pain Pract
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4. Tsai HW, Chen YJ, Ho CM, et al. Maneuvers to decrease
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