Yu et al.

Trials (2021) 22:34

[Link]

STUDY PROTOCOL Open Access

Efficacy of acupuncture for sciatica: study

protocol for a randomized controlled pilot
trial
Fang-Ting Yu1,2, Guang-Xia Ni3, Guo-Wei Cai4, Wen-Jun Wan5, Xiao-Qing Zhou6, Xiu-Li Meng7, Jin-Ling Li1,2,
Jian-Feng Tu1,2, Li-Qiong Wang1,2, Jing-Wen Yang1,2, Hai-Yang Fu8, Xin-Chang Zhang3, Jing Li4, Yan-Fu Wang5,
Beng Zhang6, Xiao-Hui Zhang9, Hao-Lin Zhang9, Guang-Xia Shi1,2* and Cun-Zhi Liu1,2,10

Abstract
Background: Acupuncture is widely used for pain diseases while evidence of its efficacy for sciatica is insufficient.
We aim to explore the feasibility and efficacy of acupuncture with different acupoint selecting strategies for sciatica
induced by lumbar disc herniation.
Methods: This is a multicenter, three-arm, patient-assessor-blinded randomized controlled pilot trial. Ninety patients
will be assigned randomly into 3 groups including disease-affected meridians (DAM) group, non-affected meridians
(NAM) group, and sham acupuncture (SA) group in a 1:1:1 ratio. The trial involves a 4-week treatment along with
follow-up for 22 weeks. The primary outcome is the change of leg pain intensity measured by the visual analogue
scale (VAS) from baseline to week 4 after randomization. Secondary outcomes include functional status, back pain
intensity, and quality of life. Adverse events will also be recorded.
Discussion: The results will inspire the optimal acupuncture strategy for sciatica and help establish a better design
as well as power calculation for a full-scale study.
Trial registration: ChiCTR2000030680 (Chinese Clinical Trial Registry, [Link] registered on 9
March 2020).

Background Conservative treatments are the first-line options for

Sciatica is characterized by radiating leg pain along the sciatica [5, 6]. Medicine and epidural steroid injection
course of the sciatic nerve sometimes accompanied by are commonly used although long-term benefits are un-
back pain and neurological deficits [1]. The prevalence certain and side effects (e.g., headache and dizziness) or
ranges from 1.2 to 43% globally based on controversial complications (e.g., epidural hematoma) occur some-
definitions [2]. Lumbar disc herniation is the leading times [7–9]. Most pain and related disabilities could re-
cause of 85% of patients with sciatica [3]. Sciatica affects solve in weeks [5], but up to 30% of patients were
daily life and productivity and consumes more health re- reported with pain lasting for 1 year or longer [10].
sources when compared to low back pain [4]. Therefore, long-term effective and safe conservative
treatments might be potential solutions.
* Correspondence: shiguangxia2008@[Link] Acupuncture has been widely used for pain diseases.
1
International Acupuncture and Moxibustion Innovation Institute, Beijing Meta-analysis indicated that acupuncture had a persist-
University of Chinese Medicine, Beijing 100029, China
2 ent effect on 4 chronic pains which decreased only 15%
Acupuncture Research Center, School of Acupuncture-Moxibustion and
Tuina, Beijing University of Chinese Medicine, Beijing 100029, China after 1 year [11]. However, high-quality evidence remains
Full list of author information is available at the end of the article

© The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License,
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Yu et al. Trials (2021) 22:34 Page 2 of 9

scarce for acupuncture treating sciatica [12, 13]. Acu- and Technology; the Department of acupuncture,
points play a key role in treatment that different acu- Shenzhen Hospital, Beijing University of Chinese
point selecting strategies could generate discrepant Medicine; the Department of pain medicine center
effects [14, 15]. To optimize acupuncture strategy for and traditional Chinese medicine, Peking University
sciatica, this pilot study will evaluate feasibility and effi- Third Hospital; and the Department of acupuncture,
cacy of acupuncture with different acupoint selecting Dongzhimen Hospital Affiliated to Beijing University
methods. The hypothesis is that acupuncture on disease- of Chinese Medicine. The Research Ethics Committee
affected meridians might have better effects. Reliable of Beijing University of Chinese Medicine has ap-
data will be used to develop a better design including proved the study protocol (version 2.0, 13 January
sample size calculation for a further randomized con- 2020) with an approval number of 2020BZHYLL0105.
trolled trial (RCT). It was registered at the Chinese Clinical Trial Registry
([Link] on 9th March 2020 with
Methods/design the registration number of ChiCTR2000030680. The
Study design protocol is reported in accordance with the Standard
The detailed study process is illustrated in Fig. 1. We de- Protocol Items (SPIRIT) (Additional file 1).
sign this multicenter, parallel-group, patient-assessor
blinded RCT following the Consolidated Standards of Patients
Reporting Trials (CONSORT) and the Standards for There will be 6 centers conducting this study to ensure
Reporting Interventions in Clinical Trials of Acupunc- recruitments where many patients visit doctors for sciat-
ture (STRICTA) guidelines [16, 17]. The trial will be ica every day. Eligible patients will be recruited from
conducted in outpatient departments of 6 hospitals in 4 outpatient clinics through advertisements on posters,
cities in China, including the Department of acupunc- newspapers, and WeChat. To promote recruitment as
ture, Union Hospital, Union Hospital, Tongji Medical well as compliance, all treatment during the study will
College, Huazhong University of Science and Technol- be offered freely.
ogy; the Department of acupuncture, Affiliated Hospital
of Nanjing University of Chinese Medicine; the Depart- Inclusion criteria
ment of Rehabilitation, the Central Hospital of Wuhan, The study will include both male and female patients (1)
Tongji Medical College, Huazhong University of Science aged between 18 and 70 years; (2) having symptoms of
sciatica for 1 month or longer from the onset, diagnosed
as unilateral radiating leg pain below the knee with posi-
tive straight-leg raise test or at least one neurological
deficit symptoms as paraesthesia, muscle weakness, or
reflex abnormalities. The imaging evidence of lumbar
disc herniation is requested on either magnetic reson-
ance imaging (MRI) or computed tomography (CT); (3)
leg pain intensity for 40 mm or more measured by the
visual analogue scale (VAS) [18].

Exclusion criteria
Patients will be excluded if they meet any of the follow-
ing criteria: (1) patients who have or are suspected to
have severe spinal diseases (e.g., cauda equina syndrome)
or progressive neurological symptoms (e.g., progressive
muscle weakness); (2) patients with sciatica caused by
other conditions than lumbar disc herniation; (3) pa-
tients who have undergone surgery for lumbar disc her-
niation within the past 6 months; (4) patients who plan
to have spinal surgery or other interventional therapies
during the first 4 weeks of the trial; (5) patients continu-
ally taking antiepileptic medication, antidepressant medi-
cation, opioids or corticosteroids; (6) patients who have
cardiovascular, liver, kidney, or hematopoietic system
Fig. 1 Flowchart of the trial procedure. DAM, disease-affected
diseases, mental health disorders, or other severe coex-
meridians; NAM, non-affected meridians; SA, sham acupuncture
isting diseases (e.g., cancer); (7) patients who are
Yu et al. Trials (2021) 22:34 Page 3 of 9

pregnant, breastfeeding, or planning to conceive during Interventions

the trial; (8) patients who received acupuncture therapy All patients will receive advice for managing sciatica in
within the past 6 months. daily life such as remaining active, using a hard bed, or
losing weight. Based on the assignment, they will receive
Dropout criteria 12 sessions of 30-min treatments over 4 weeks (ideally 3
Patients will be removed if they are unwilling to con- times a week with an interval of 1 or 2 days). Acupoints
tinue participation. The reasons for dropouts will be are predefined based on experienced acupuncturists’
recorded. consensus and literature review [19]. Locations of acu-
points are all according to the WHO Standard Acupunc-
Randomization ture Locations shown in Tables 1 and 2 and Fig. 3 [20].
An independent statistician will generate the random se- Patients could ask for Celebrex (Pfizer Pharmaceutical
quence by the central block randomization method Co., Ltd) from researchers with guidance, and the use
using IBM SPSS Statistics, version 21.0 (International will be recorded in detail.
Business Machines Corporation, China). Eligible patients
will be assigned randomly into the disease-affected me- DAM group
ridians (DAM) group, non-affected meridians (NAM) Semi-standardized treatment will be provided with acu-
group, and sham acupuncture (SA) in a 1:1:1 ratio. An points on affected meridians in this group. There will be
independent researcher in charge of informing assign- four obligatory acupoints and five adjunct acupoints.
ment will implement the allocation schedule through a Obligatory acupoints are bilateral Dachangshu (BL25)
centralized telephone randomization procedure. To en- and Guanyuanshu (BL26). Depending on the distribution
sure the allocation concealment, acupuncturists will of the pain, sciatica localized at the side of the affected
make a call to ask for the information of assignment be- leg will be treated with adjunct acupoints on gallbladder
fore the first treatment. The independent researcher will meridian including Huangtiao (GB30), Fengshi (GB31),
send messages containing allocation details immediately. Xiyangguan (GB33), Yanglingquan (GB34), and Xuanz-
Before randomization, trial information will be provided hong (GB39). Sciatica localized at the back of the af-
to each eligible patient. Researchers (doctors) will get fected leg will be treated with adjunct acupoints on
written informed consent from eligible patients who are bladder meridian including Zhibian (BL54), Chengfu
willing to participate. (BL36), Weizhong (BL40), Chengshan (BL57), and Kun-
lun (BL60). For patients with pain in both side and back,
Blinding adjunct acupoints will be selected from the ten adjunct
Patients, outcome assessors, and statistician will be acupoints above based on the personal experiences of
blinded to the assignment. Differences between groups acupuncturists.
present mainly at point selections and acupuncture per- After strict disinfection of the skin around acupoints
formance. Blunt-tipped needles for blinding will be simi- and acupuncturists’ hands using 75% alcohol, adhesive
lar to conventional needles. Adhesive foam pads will be foam pads (10-mm diameter and 5-mm height) will be
put on treating points to cover the difference in acu- placed on all acupoints with patients in a prone position.
puncture performance (Fig. 2). Disposable stainless steel acupuncture needles (0.30 × 75
mm, Suzhou Huatuo Medical Instrument Co, Ltd) will
be inserted in BL25 and BL26 on the affected side deeply
to 40–70 mm. After performing twirling, lifting, and
thrusting manipulations for about 10 s, patients are ex-
pected to have “de qi” sensation (a complex feeling in-
cluding soreness, numbness, heaviness, distention and
dull pain, etc.) radiating down to the affected leg. Other
acupoints will be treated with needles (0.30 mm × 40/50/
75 mm) inserted to normal depths to reach “de qi” sen-
sation locally. All needles will be retained for 30 min.

NAM group
Nine acupoints on non-affected meridians will be used
as follows: bilateral Yaoyan (EX-B7) and Pigen (EX-B4)
and unilateral Yinbao (LR9), Ququan (LR8), Ligou
(LR5), Fuliu (KI7), and Gongsun (SP4) on the affected
Fig. 2 Schematic diagram of acupuncture and sham acupuncture
leg. All acupoints will be treated by needles (0.30 × 40/
Yu et al. Trials (2021) 22:34 Page 4 of 9

Table 1 Location of acupoints in DAM group

Acupoints Location
Dachangshu (BL25) In the lumbar region, at the same level as the inferior border of the spinous process of the
fourth lumbar vertebra (L4), 1.5 cun lateral to the posterior median line.
Guanyuanshu (BL26) In the lumbar region, at the same level as the inferior border of the spinous process of the
fifth lumbar vertebra (L5), 1.5 cun lateral to the posterior median line
Huantiao (GB30) In the buttock region, at the junction of the lateral one third and medial two thirds of the
line connecting the prominence of the greater trochanter with the sacral hiatus.
Fengshi (GB31) On the lateral aspect of the thigh, in the depression posterior to the iliotibial band where
the tip of the middle finger rests, when standing up with the arms hanging alongside the thigh.
Xiyangguan (GB33) On the lateral aspect of the knee, in the depression between the biceps femoris tendon
and the iliotibial band, posterior and proximal to the lateral epicondyle of the femur.
Yanglingquan (GB34) On the fibular aspect of the leg, in the depression anterior and distal to the head of the fibula.
Xuanzhong (GB39) On the fibular aspect of the leg, anterior to the fibula, 3 cun proximal to the prominence of
the lateral malleolus.
Zhibian (BL54) In the buttock region, at the same level as the fourth posterior sacral foramen, 3 cun lateral
to the median sacral crest.
Chengfu (BL36) In the buttock region, at the midpoint of the gluteal fold.
Weizhong (BL40) On the posterior aspect of the knee, at the midpoint of the popliteal crease.
Chengshan (BL57) On the posterior aspect of the leg, at the connecting point of the calcaneal tendon with
the two muscle bellies of the gastrocnemius muscle.
Kunlun (BL60) On the posterolateral aspect of the ankle, in the depression between the prominence of
the lateral malleolus and the calcaneal tendon.
One “cun” is defined as the width of the interphalangeal joint of patient’s thumb

50 mm) inserted into the skin with manipulations later is required in this group and other settings will be the
to reach the “de qi” sensation. Other treatment settings same.
are the same as those for the DAM group.

SA group Outcomes
We select nine non-acupoints in this group with loca- The primary outcome is defined as the change of leg
tions shown in Table 3. They are localized in the middle pain intensity on VAS from baseline to week 4 measur-
of the gallbladder meridian and bladder meridian as one ing pain over the prior 24 h. The VAS presents as a 0–
selecting method for non-acupoints [21]. Blunt-tipped 100 mm ruler with 0 representing no pain and 100
needles (0.30 × 25 mm) will be inserted only into the pad representing unbearable pain. The specific score will be
with no penetration into the skin. No “de qi” sensation determined by the distance from 0 to the patient’s mark.

Table 2 Location of acupoints in NAM group

Acupoints Location
Yaoyan (EX-B7) In the lumbar region, at the same level as the inferior border of the spinous process of
the fourth lumbar vertebra (L4), 3.5 cun lateral to the posterior median line.
Pigen (EX-B4) In the lumbar region, at the same level as the inferior border of the spinous process of
the first lumbar vertebra (L1), 3.5 cun lateral to the posterior median line.
Yinbao (LR9) On the medial aspect of the thigh, between the gracilis and the sartorius muscles, 4 cun
proximal to the base of the patella.
Ququan (LR8) On the medial aspect of the knee, in the depression medial to the tendons of the
semitendinosus and the semimembranosus muscles, at the medial end of the popliteal
crease.
Ligou (LR5) On the anteromedial aspect of the leg, at the center of the medial border (surface) of
the tibia, 5 cun proximal to the prominence of the medial malleolus.
Fuliu (KI7) On the posteromedial aspect of the leg, anterior to the calcaneal tendon, 2 cun superior
to the prominence of the medial malleolus.
Gongsun (SP4) On the medial aspect of the foot, anteroinferior to the base of the first metatarsal bone,
at the border between the red and white flesh.
One “cun” is defined as the width of the interphalangeal joint of patient’s thumb
Yu et al. Trials (2021) 22:34 Page 5 of 9

Fig. 3 Locations of acupoints and non-acupoints. DAM, disease-affected meridians; NAM, non-affected meridians; SA, sham acupuncture

Secondary outcomes include VAS for leg pain and SF-36 is used to assess the quality of life on eight as-
back pain at other time points, Oswestry Disability pects including physical functioning, bodily pain, role
Index (ODI) [22], the Sciatica Frequency and Bother- limitations due to physical health problems, personal
someness Index (SFBI) [23], 36-item Short Form or emotional problems, emotional well-being, social
Health Survey (SF-36) [24], straight leg raise test [25], functioning, energy/fatigue, general health perceptions,
painDETECT questionnaire [26], global perceived re- and a single item that indicates perceived change in
covery on 7-point Likert self-rating scale [27], the health. PainDETECT questionnaire is used to discern
Credibility/Expectancy Questionnaire [28], blinding the variation of neuropathic pain as one common
assessment and medicine use. The ODI plays a role method. A 7-point Likert self-rating scale is used to
in giving a subjective percentage score of function assess the recovery compared to the onset with op-
level for patients with low back pain through examin- tions from “completely recovered” to “worse than
ing perceived disability in 10 activities of daily living. ever.” The Credibility/Expectancy Questionnaire is
The SFBI measures the frequency and symptom se- capable to assess the credibility and expectancy of pa-
verity with scores ranging from 0 to 24 respectively. tients. Maintenance of blinding will be determined by

Table 3 Location of non-acupoints in SA group

Non-acupoints Location
NA 1 (bilateral) In the lumbar region, 2.5 cun beside Dachangshu (BL25), in the middle of gallbladder meridian and bladder meridian.
NA 2 (bilateral) In the lumbar region, 2.5 cun beside Guanyuanshu (BL26), in the middle of gallbladder meridian and bladder meridian.
NA 3 In the middle of Zhibian (BL54) and Huantiao (GB30) acupoints on the affected leg.
NA 4 10 cun above the popliteal crease, in the middle of gallbladder meridian and bladder meridian on the affected leg.
NA 5 5 cun above the popliteal crease, in the middle of gallbladder meridian and bladder meridian on the affected leg.
NA 6 In the middle of Weizhong (BL40) and Yanglingquan (GB34) acupoints on the affected leg.
NA 7 In the middle of Chengshan (BL57) and Waiqiu (GB36) acupoints on the affected leg.
One “cun” is defined as the width of the interphalangeal joint of patient’s thumb
Yu et al. Trials (2021) 22:34 Page 6 of 9

Table 4 Schedule of recruitment, interventions, and assessments

DAM disease-affected meridians, NAM non-affected meridians, SA sham acupuncture, w week, VAS visual analogue scale, ODI Oswestry Disability Index, SFBI the
Sciatica Frequency and Bothersomeness Index, SF-36 36-item Short Form Health Survey

asking patients to report the group which they believe charge of the completed CRFs, he will be asked to input
they had been assigned to. Categories and frequency data doubly for proofreading. All data related to the trial
of medicines use during the trial will be recorded in will be saved for at least 5 years after publication.
detail. Detailed arrangements of every outcome are Readers will be permitted to access the original data by
shown in Table 4. contacting the corresponding author. Information on pa-
Adverse events will be recorded, valued, and treated tients will remain anonymous including name, age, and
timely. Continuous investigation and reexaminations will telephone number. An independent DSMB is established
be conducted until the end of the study. Independent to ensure the integrity of the research data. The DSMB
clinical specialists who are blinded to the assignment will review the progress and decide whether a premature
will judge the severity and relationship between adverse closure is needed or not.
events and acupuncture. Sever adverse events will be re-
ported to the principal investigator and the data and Quality control
safety monitor board (DSMB) within 24 h after occur- The study protocol has been reviewed and revised by ex-
rence to determine subsequent participation. The occur- perts of acupuncture, orthopedics, statistics, and meth-
rence ratio of adverse events will be calculated at the odology. All researchers who conduct the study will
end of the study. attend a series of training to promote the implementa-
tion. Data will be monitored on 3 levels by the head of
Data management sub-centers, researchers from the Beijing University of
Data will be collected clearly and completely on case re- Chinese Medicine, and the DSMB pre-set for this study.
port forms (CRFs). All original data sources will be pre- The Research Ethics Committee of Beijing University of
served including CRFs, informed consents, and Chinese Medicine will audit the study on a regular basis
inspection results. An independent data manager is in independently.