Fu et al.

Trials 2014, 15:130

TRIALS
http://www.trialsjournal.com/content/15/1/130

STUDY PROTOCOL Open Access

Acupuncture at local and distal points for chronic

shoulder pain: study protocol for a randomized
controlled trial
Qing-Nan Fu1,2, Guang-Xia Shi1, Qian-Qian Li1, Tian He1, Bao-Zhen Liu3, San-Feng Sun3, Jun Wang4, Cheng Tan4,
Bo-Feng Yang1 and Cun-Zhi Liu1*

Abstract
Background: Chronic shoulder pain (CSP) is the third most common type of musculoskeletal pain. It has a major
impact on health-related quality of life. In Chinese medicine, CSP is considered one of the conditions most
amenable to treatment with acupuncture. The purpose of this study is to evaluate the efficacy of local acupoints in
combination with distal acupoints in pain relief and shoulder function improvement in CSP patients.
Methods/Design: This is a multicenter, single blind, factorial randomized controlled clinical trial. A total of 164
participants will be randomly allocated to four different groups: Group A will receive acupuncture at local acupoints
in combination with distal acupoint. Group B will receive acupuncture at local acupoints in combination with distal
non-acupoint. Group C will receive acupuncture at local non-acupoints in combination with distal acupoint. Group
D will receive acupuncture at local non-acupoints in combination with distal non-acupoint. Each group will receive
12 treatments of acupuncture one to three times per week for six weeks in total. The primary outcome is shoulder
pain intensity, which is graded using a 100 -mm Visual Analogue Scale. The assessment is at baseline (before
treatment initiation), 6 weeks after the first acupuncture, 10 weeks after the first acupuncture and 18 weeks after
the first acupuncture.
Discussion: This trial will be helpful in identifying whether acupuncture at local acupoints in combination with
distal acupoints may be more effective than needling points separately.
Trial registration: International Standard Randomized Controlled Trial Number Register: ISRCTN61861069
(http://www.controlled-trials.com).

Background the long run [4-6]. In Chinese medicine, CSP is consid-

Chronic shoulder pain (CSP) is the third most common ered one of the conditions most amenable to treatment
type of musculoskeletal pain. It has a major impact on with acupuncture [4]. The purpose of this study is to
health-related quality of life [1]. Disorders of the shoul- evaluate whether local acupoints in combination with
der muscles and tendons (rotator cuff ) are thought to be distal acupoints are more effective than local acupoints
the most common causes of the pain [2]. The true or distal acupoints alone in pain relief and shoulder
prevalence is unknown, varying in different reports from function improvement in CSP patients.
4 to 34% [3]. The conventional treatments for shoulder
pain are NSAIDs, physiotherapy, cortisone injections Methods/Design
and ‘wait and see’ [4,5]. Unfortunately, none of these Ethics
treatments are clearly proven to be effective for CSP in The study is in accordance with the Declaration of
Helsinki and has been approved by the Research Ethical
* Correspondence: lcz623780@126.com Committee of Beijing Hospital of Traditional Chinese
1
Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Medicine Affiliated to Capital Medical University(refer-
Chinese Medicine affiliated to Capital Medical University, 23 Meishuguanhou
Street, Dongcheng District, Beijing 100010, China ence: 201315). This trial was registered with ISRCTN at
Full list of author information is available at the end of the article Current Controlled Trials (ISRCTN61861069). Before
© 2014 Fu et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain
Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article,
unless otherwise stated.
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randomization all patients will be requested to sign a individuals had not received acupuncture in the preceding
written informed consent, and they will also be given month; and a signed informed consent form.
enough time to decide whether they are willing to par-
ticipate in the trial or choose other treatment options.
Exclusion criteria
The exclusion criteria are as follows: referred pain from the
Population
cervical spine, history of shoulder trauma, shoulder surgery,
Patients will be recruited in acupuncture clinics in the
stoke, ipsilateral breast surgery, heart diseases and severe
Beijing Hospital of Traditional Chinese Medicine Affili-
hypertension; osteoarthritis of the glenohumeral joint or
ated to Capital Medical University, the Beijing Huairou
systemic bone and joint disorder (rheumatoid arthritis);
District Hospital of Traditional Chinese Medicine, and
endocrine diseases such as hyperthyroidism; severe infec-
the Dongzhimen Hospital Affiliated to Beijing University
tion; and undergoing current therapy involving analgesics.
of Chinese Medicine, with a target sample size of 164
subjects. The trial will be executed from January 2014 to
December 2015. Interventions
The participating acupuncturists will be members who
Recruitment of participants have been qualified for at least three years and who hold
Two strategies will be used to recruit participants with a Chinese medicine practitioner license from the Minis-
CSP. One is to recruit participants in outpatient clinics try of Health of the People’s Republic of China. The acu-
from the three hospitals mentioned above. The other is puncture treatments will be performed according to a
to show recruitment posters outside the clinics. The treatment protocol already developed for this purpose.
posters will contain brief introductions about the popu- This will allow for each patient having a customized
lation needed, the free acupuncture treatments offered treatment within a standardized theory-driven frame-
to eligible participants, and the contact information of work. All patients will have a standardized interview and
the researcher. Screening forms will be completed by in- receive more information about the study and treat-
terested patients, which will be conducted via a face-to- ments. Patients are informed in a manner suggesting
face interview and assessment with a researcher at one that four different types of acupuncture treatment are
of the hospital sites prior to randomization. compared some are traditional and others are new. As
the effect of all four is uncertain, terms such as ‘placebo’
Inclusion criteria or ‘sham’ were not used. Similar strategies of informed
Patients who meet all of the following conditions will be consent have been used in most previous acupuncture
considered for enrollment. The inclusion criteria are as trials [7]. After obtaining informed consent from each
follows: aged between 25 and 65 years (either sex); participant and completing a baseline evaluation, they
present with a primary complaint of shoulder pain with will receive 12 treatments of acupuncture, one to three
one-sided shoulder pain for at least six weeks and up to times per week for six weeks in total. Time points are as
two years; a pain score of 50 mm or more on a 100 -mm shown in Figure 1.
visual analogue scale (VAS); plain radiography is normal, Patients who meet the inclusion criteria are random-
but osteoporosis or a calcification shadow may be present; ized to one of four treatment groups:

Figure 1 Flow chart.

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Group A will receive acupuncture at local acupoints in The doctor should ensure the patient is kept in the sit-
combination with distal acupoint. ting position, and insert a 0.25 mm × 75 mm acupuncture
Group B will receive acupuncture at local acupoints in needle from ST 38 to BL 57 (Chengshan). The needle will
combination with distal non-acupoint. be rotated up and down to induce a needle sensation
Group C will receive acupuncture at local non- (called ‘de qi’) for 30 seconds. At the same time, the
acupoints in combination with distal acupoint. patient will be instructed to demonstrate a small amount
Group D will receive acupuncture at local non- of range of motion in the shoulder, such as abduction, ex-
acupoints in combination with distal non-acupoint. ternal rotation and elevation. Local acupoints will be
We selected local acupoints and local non-acupoints inserted 10 to 15 mm in depth with a 0.25 mm × 40 mm
on the same side of the shoulder lesion, while distal acu- acupuncture needle. Local non-acupoints and distal non-
point and distal non-acupoint were opposite to the acupoint will be inserted less than 5 mm in depth with a
shoulder lesion. Acupuncture points are selected as 0.25 mm × 40 mm acupuncture needle.
shown in Figure 2. Local acupoints: Jianyu (LI 15),
Jianliao (TE 14), Jianzhen (SI 9), Binao (LI 14). Distal Randomization and blinding
acupoint: Tiaokou (ST 38). Local non-acupoints (LN): This is a block randomized single blind 2 × 2 factorial
(1) anterior axillary fold; (2) posterior axillary fold; (3) in design. Randomization is to be conducted by a statistics
the shoulder department, 2 cm below Tianzong (SI 11); specialist who will have no contact with the participants.
(4) inside of the upper arm side, Tianfu (LU 3) inward Random numbers with block randomization are gener-
1 cm, between pericardium meridian and lung meridian. ated with SAS software (SAS Institute, Inc., Cary, NC,
Distal non-acupoint (DN): lateral to the shank, 3 cun USA). Participants will be allocated to one of the four
below Yanglingquan (GB34), the midway between gall groups at a ratio of 1:1:1:1. The research coordinator,
bladder meridian and bladder meridian. who will not be involved with data collection, will in-
We will use sterile, prepacked needles (Huatuo dispos- form the acupuncturist of the treatment assignment via
able acupuncture needle, Suzhou Medical Co. Ltd., the telephone.
Jiangsu, China). The sizes to be used are 0.25 mm × The patients, data collection staff, and data analysts will
40 mm and 0.25 × 75 mm. The doctor will first insert a be blinded during the study period. Acupuncturists are not
needle into the distal acupoint or distal non-acupoint blinded to the treatments they deliver due to the nature of
(during the needling of these distal points a brief move- the intervention. During the intervention, the acupuncturist
ment of the shoulder is allowed) for 20 minutes, and and personnel who collect data will be segregated immedi-
then insert a needle into the local acupoints or local ately after the start of treatment and are instructed not to
non-acupoints for a further 20 minutes. exchange information with each other.

Figure 2 The points used in the trial.

Fu et al. Trials 2014, 15:130 Page 4 of 5
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Primary outcome measures is 34 patients in each group. Allowing for 20% attrition,
Shoulder pain intensity will be graded using a 100-mm we should recruit 164 patients, with 41 in each group.
Visual Analogue Scale (VAS) by patients themselves, with
0 representing ‘no pain at all’ and 100 mm representing Data analysis
‘the most intense pain imaginable’ [4]. The assessment is Statisticians who are independent from the research
at baseline (before treatment initiation), 6 weeks after the team will analyze data in accordance with a 2 × 2 ran-
first acupuncture, 10 weeks after the first acupuncture and domized factorial study design. Every analysis is to be
18 weeks after the first acupuncture. conducted using the software of SPSS 12.0. The statis-
tical model includes two fixed factors (local acupoints
Secondary outcome measures and distal acupoints). Interaction is to be evaluated by
There will be three secondary outcome measures. First, the interaction term in the analysis of variance
functions of the shoulder joint will be evaluated using (ANOVA) model and visual assessment of profile plots.
the Constant-Murley score (CMS). This consists of four
domains: pain (one item), activities of daily living (ADL; Discussion
three items for activity level, such as work, sports and We have presented the design and protocol for the ran-
sleep), one item for hand positioning (rotation), mobility domized controlled trial of acupuncture at local and dis-
(four items: forward and lateral abduction and elevation, tal points for CSP. Completion of this trial will help to
external and internal rotation), and power or strength identify whether acupuncture at local acupoints in com-
(one item). Pain and ADL 1 to 3 are interviewed from bination with distal acupoints are more effective than
the patient (self-assessed); all other items are assessed by local acupoints or distal acupoints alone.
examiner [8]. The assessment will be performed at base- A Cochrane systematic review of acupuncture for
line (before treatment initiation), 6 weeks after the first shoulder pain concluded that there is not enough pub-
acupuncture, 10 weeks after the first acupuncture, and lished evidence of sufficient quality to support or refute
18 weeks after of the first acupuncture. Second, the its use [12]. A trial of acupuncture for shoulder pain
quality of life is assessed using Short form-36 (SF-36) concluded that acupuncture is an effective long-term
[9]. The assessment is at baseline (before treatment initi- treatment for patients with shoulder pain (from soft-
ation), 6 weeks after the first acupuncture, 10 weeks tissue lesions) in a primary care setting [13]. Typically
after the first acupuncture and 18 weeks after the first acupuncturists often use a combination of local and distal
acupuncture. Third, the perceived credibility of acupunc- points to treat a condition such as CSP. According to ex-
ture is evaluated by The Treatment Credibility Scale perience from our clinical practice, we consider that distal
(TCS) [10] after a 6-week acupuncture session. It is a points could improve range of motion while local points
five-item questionnaire ranging from 1 (not at all) to 5 could be effective in providing pain relief. Therefore we
(very confident). Items are averaged to provide a single hypothesize that acupuncture at local acupoints in com-
treatment credibility score, with high scores reflecting bination with distal acupoints may be more effective than
high treatment credibility. needling points separately to treat CSP. This project will
Participants will also be advised to report any adverse not only increase the knowledge about the effects of acu-
events they experience, including discomfort or bruising puncture treatment for CSP, but also confirm the effect of
at the sites of needle insertion, nausea, or feeling faint a combination of local and distal acupoints.
after a 6-week acupuncture treatment.
Trial status
Sample Size This trial is currently recruiting participants.
According to the previous pilot study [4],an average 20-
Abbreviations
point reduction on the VAS scores relating to shoulder
CSP: Chronic shoulder pain; CMS: Constant-Murley score; SF-36: Short
pain has a clinically significant difference, and percent- form-36; TCS: Treatment Credibility Scale; VAS: Visual Analogue Scale.
ages of responders for the primary endpoint are verum
65%, sham 24%. The following formula is used for a Competing interests
The authors declare that they have no competing interests.
four-group trial [11]:
Authors’ contributions
CZL: conception and design, critical revision for important intellectual
2λ content and final approval of the manuscript. QNF: conception and design,
n¼ pffiffiffiffiffiffiffiffiffi 2 drafting the manuscript and final approval of the manuscript. GXS:
2sin‐1 Pmax ‐2sin‐1 Pmin
conception and design, drafting the manuscript and final approval of the
manuscript. QQL: data collection and analysis and final approval of the
manuscript. TH: data collection and analysis and final approval of the
Based on 0.9 power to detect a significant difference manuscript. BZL: conception and design, final approval of the manuscript.
(α = 0.05,ν = 4-1 = 3,λ =14.17), the required sample size SFS: data collection and analysis and final approval of the manuscript. JW:
Fu et al. Trials 2014, 15:130 Page 5 of 5
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data collection and analysis, final approval of the manuscript. CT: data 11. Hu LP: SAS Experimental Design and Statistical Analysis. Beijing: People’s
collection and analysis and final approval of the manuscript. BFY: data Medical Publishing House; 2010.
collection and analysis and final approval of the manuscript. All authors have 12. Green S, Buchbinder R, Hetrick S: Acupuncture for shoulder pain. Cochrane
read and approved the manuscript. Database Syst Rev 2005, 2:CD005319.
13. Guerra De Hoyos JA, Andrés Martín Mdel C, Bassas y Baena de Leon E,
Vigára Lopez M, Molina López T, Verdugo Morilla FA, González Moreno MJ:
Acknowledgements Randomized trial of long term effect of acupuncture for shoulder pain.
The trial is sponsored by the National Natural Science Foundation for Pain 2004, 112:289–298.
Excellent Young Scholars of China (Grant No. 81222050), the Beijing
Technology Development of Traditional Chinese Medicine Foundation – doi:10.1186/1745-6215-15-130
Annual Planning Project (ref: JJ 2013-40), and the Beijing Health System - Cite this article as: Fu et al.: Acupuncture at local and distal points for
High Level Health Technology Talent Cultivation Plan chronic shoulder pain: study protocol for a randomized controlled trial.
(ref: 2011-3-055). Trials 2014 15:130.

Author details
1
Acupuncture and Moxibustion Department, Beijing Hospital of Traditional
Chinese Medicine affiliated to Capital Medical University, 23 Meishuguanhou
Street, Dongcheng District, Beijing 100010, China. 2Shandong University of
Traditional Chinese Medicine, Jingshi Street, Lixia District, Jinan 250014,
China. 3Beijing Huairou District Hospital of Chinese Medicine, 1 Houheng
Street jia, Huairou District, Beijing 101400, China. 4Dongzhimen Hospital
Affiliated to Beijing University of Chinese Medicine, 5 Haiyuncang,
Dongcheng District, Beijing 100010, China.

Received: 25 January 2014 Accepted: 3 April 2014

Published: 17 April 2014

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