current development and research in traditional chinese...

Current Development and Research in Traditional Chinese Nonpharmacologic Therapy for Pain

Guest Editors: Fan-rong Liang, Jianping Chen, Xin Gao, Richard E. Harris, and Bai-Yun Zeng

Evidence-Based Complementary and Alternative Medicine

Current Development and Research inTraditional Chinese NonpharmacologicTherapy for Pain

Evidence-Based Complementary and Alternative Medicine

Current Development and Research inTraditional Chinese NonpharmacologicTherapy for Pain

Guest Editors: Fan-rong Liang, Jianping Chen, Xin Gao,Richard E. Harris, and Bai-Yun Zeng

Copyright © 2016 Hindawi Publishing Corporation. All rights reserved.

This is a special issue published in “Evidence-Based Complementary and Alternative Medicine.” All articles are open access articlesdistributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in anymedium, provided the original work is properly cited.

Editorial Board

Mona Abdel-Tawab, GermanyJon Adams, AustraliaGabriel A. Agbor, CameroonUlysses P. Albuquerque, BrazilSamir Lutf Aleryani, USAM. S. Ali-Shtayeh, PalestineGianni Allais, ItalyTerje Alraek, NorwayShrikant Anant, USAIsabel Andújar, SpainLetizia Angiolella, ItalyVirginia A. Aparicio, SpainMakoto Arai, JapanHyunsu Bae, Republic of KoreaGiacinto Bagetta, ItalyOnesmo B. Balemba, USAWinfried Banzer, GermanyPanos Barlas, UKVernon A. Barnes, USASamra Bashir, PakistanJairo Kennup Bastos, BrazilArpita Basu, USASujit Basu, USAGeorge David Baxter, New ZealandAndré-Michael Beer, GermanyAlvin J. Beitz, USALouise Bennett, AustraliaMaria Camilla Bergonzi, ItalyAnna R. Bilia, ItalyYong C. Boo, Republic of KoreaMonica Borgatti, ItalyFrancesca Borrelli, ItalyGloria Brusotti, ItalyArndt Büssing, GermanyRainer W. Bussmann, USAAndrew J. Butler, USAGioacchino Calapai, ItalyGiuseppe Caminiti, ItalyRaffaele Capasso, ItalyFrancesco Cardini, ItalyOpher Caspi, IsraelSubrata Chakrabarti, CanadaPierre Champy, FranceShun-Wan Chan, Hong KongIl-Moo Chang, Republic of Korea

Kevin Chen, USAEvan P. Cherniack, USASalvatore Chirumbolo, ItalyJae Youl Cho, Republic of KoreaK. Bisgaard Christensen, DenmarkShuang-En Chuang, TaiwanY. Clement, Trinidad And TobagoPaolo Coghi, ItalyMarisa Colone, ItalyLisa A. Conboy, USAKieran Cooley, CanadaEdwin L. Cooper, USAOlivia Corcoran, UKMuriel Cuendet, SwitzerlandRoberto K. N. Cuman, BrazilVincenzo De Feo, ItalyRocío De la Puerta, SpainLaura De Martino, ItalyNunziatina De Tommasi, ItalyAlexandra Deters, GermanyFarzad Deyhim, USAManuela Di Franco, ItalyClaudia Di Giacomo, ItalyAntonella Di Sotto, ItalyM.-G. Dijoux-Franca, FranceLuciana Dini, ItalyCaigan Du, CanadaJeng-Ren Duann, USANativ Dudai, IsraelThomas Efferth, GermanyAbir El-Alfy, USATobias Esch, USAGiuseppe Esposito, ItalyKeturah R. Faurot, USANianping Feng, ChinaYibin Feng, Hong KongPatricia D. Fernandes, BrazilJosue Fernandez-Carnero, SpainAntonella Fioravanti, ItalyFabio Firenzuoli, ItalyPeter Fisher, UKFilippo Fratini, ItalyBrett Froeliger, USAMaria pia Fuggetta, ItalyJoel J. Gagnier, Canada

Siew Hua Gan, MalaysiaJian-Li Gao, ChinaMary K. Garcia, USASusana Garcia de Arriba, GermanyDolores García Giménez, SpainGabino Garrido, ChileIpek Goktepe, QatarMichael Goldstein, USAYuewen Gong, CanadaSettimio Grimaldi, ItalyGloria Gronowicz, USAMaruti Ram Gudavalli, USAAlessandra Guerrini, ItalyNarcis Gusi, SpainSvein Haavik, NorwaySolomon Habtemariam, UKAbid Hamid, IndiaMichael G. Hammes, GermanyKuzhuvelil B. Harikumar, IndiaCory S. Harris, CanadaThierry Hennebelle, FranceLise Hestbaek, DenmarkEleanor Holroyd, AustraliaMarkus Horneber, GermanyChing-Liang Hsieh, TaiwanBenny T. K. Huat, SingaporeR. Huber, GermanyHelmut Hugel, AustraliaCiara Hughes, IrelandAttila Hunyadi, HungarySumiko Hyuga, JapanH. Stephen Injeyan, CanadaChie Ishikawa, JapanAngelo A. Izzo, ItalyChris J. Branford-White, UKSuresh Jadhav, IndiaG. K. Jayaprakasha, USAZeev L Kain, USAOsamu Kanauchi, JapanWenyi Kang, ChinaShao-Hsuan Kao, TaiwanJuntra Karbwang, JapanKenji Kawakita, JapanDeborah A. Kennedy, CanadaCheorl-Ho Kim, Republic of Korea

Youn C. Kim, Republic of KoreaYoshiyuki Kimura, JapanToshiaki Kogure, JapanJian Kong, USATetsuya Konishi, JapanKarin Kraft, GermanyOmer Kucuk, USAVictor Kuete, CameroonYiu W. Kwan, Hong KongKuang C. Lai, TaiwanIlaria Lampronti, ItalyLixing Lao, Hong KongChristian Lehmann, CanadaMarco Leonti, ItalyLawrence Leung, CanadaShahar Lev-ari, IsraelChun-Guang Li, AustraliaMin Li, ChinaXiu-Min Li, USABi-Fong Lin, TaiwanHo Lin, TaiwanChristopher G. Lis, USAGerhard Litscher, AustriaI-Min Liu, TaiwanYijun Liu, USAVíctor López, SpainThomas Lundeberg, SwedenDawn M. Bellanti, USAFilippo Maggi, ItalyValentina Maggini, ItalyGail B. Mahady, USAJamal Mahajna, IsraelJuraj Majtan, SlovakiaFrancesca Mancianti, ItalyCarmen Mannucci, ItalyArroyo-Morales Manuel, SpainFulvio Marzatico, ItalyMarta Marzotto, ItalyJames H. McAuley, AustraliaKristine McGrath, AustraliaJames S. McLay, UKLewis Mehl-Madrona, USAPeter Meiser, GermanyKarin Meissner, GermanyAlbert S Mellick, AustraliaA. Guy Mensah-Nyagan, FranceAndreas Michalsen, GermanyOliver Micke, Germany

Roberto Miniero, ItalyGiovanni Mirabella, ItalyFrancesca Mondello, ItalyAlbert Moraska, USAGiuseppe Morgia, ItalyMark Moss, UKYoshiharu Motoo, JapanKamal D. Moudgil, USAYoshiki Mukudai, JapanFrauke Musial, GermanyMinKyun Na, Republic of KoreaHajime Nakae, JapanSrinivas Nammi, AustraliaKrishnadas Nandakumar, IndiaVitaly Napadow, USAMichele Navarra, ItalyIsabella Neri, ItalyPratibha V. Nerurkar, USAKaren Nieber, GermanyMenachem Oberbaum, IsraelMartin Offenbaecher, GermanyJunetsu Ogasawara, JapanKi-Wan Oh, Republic of KoreaYoshiji Ohta, JapanOlumayokun A. Olajide, UKThomas Ostermann, GermanySiyaram Pandey, CanadaBhushan Patwardhan, IndiaBerit S. Paulsen, NorwayFlorian Pfab, GermanySonia Piacente, ItalyAndrea Pieroni, ItalyRichard Pietras, USAAndrew Pipingas, AustraliaJose M. Prieto, UKHaifa Qiao, USAWaris Qidwai, PakistanXianqin Qu, AustraliaE. Ferreira Queiroz, SwitzerlandRoja Rahimi, IranKhalid Rahman, UKCheppail Ramachandran, USAElia Ranzato, ItalyKe Ren, USAMan Hee Rhee, Republic of KoreaLuigi Ricciardiello, ItalyDaniela Rigano, ItalyJosé L. Ríos, Spain

Paolo Roberti di Sarsina, ItalyMariangela Rondanelli, ItalyOmar Said, IsraelAvni Sali, AustraliaMohd Z. Salleh, MalaysiaAndreas Sandner-Kiesling, AustriaManel Santafe, SpainTadaaki Satou, JapanMichael A. Savka, USAClaudia Scherr, SwitzerlandAndrew Scholey, AustraliaRoland Schoop, SwitzerlandSven Schröder, GermanyHerbert Schwabl, SwitzerlandVeronique Seidel, UKSenthamil Selvan, USAFelice Senatore, ItalyHongcai Shang, ChinaKaren J. Sherman, USARonald Sherman, USAKuniyoshi Shimizu, JapanKan Shimpo, JapanYukihiro Shoyama, JapanMorry Silberstein, AustraliaKuttulebbai N. S. Sirajudeen, MalaysiaGraeme Smith, UKChang-Gue Son, Republic of KoreaRachid Soulimani, FranceDidier Stien, FranceCon Stough, AustraliaAnnarita Stringaro, ItalyShan-Yu Su, TaiwanBarbara Swanson, USAGiuseppe Tagarelli, ItalyOrazio Taglialatela-Scafati, ItalyTakashi Takeda, JapanGhee T. Tan, USAHirofumi Tanaka, USALay Kek Teh, MalaysiaNorman Temple, CanadaMayank Thakur, GermanyMenaka C. Thounaojam, USAEvelin Tiralongo, AustraliaStephanie Tjen-A-Looi, USAMichał Tomczyk, PolandLoren Toussaint, USAYew-Min Tzeng, TaiwanDawn M. Upchurch, USA

Konrad Urech, SwitzerlandTakuhiro Uto, JapanSandy van Vuuren, South AfricaAlfredo Vannacci, ItalyS. Vemulpad, AustraliaCarlo Ventura, ItalyGiuseppe Venturella, ItalyAristo Vojdani, USAChong-Zhi Wang, USAShu-Ming Wang, USA

Yong Wang, USAJonathan L. Wardle, AustraliaKenji Watanabe, JapanJ. Wattanathorn, ThailandMichael Weber, GermanySilvia Wein, GermanyJanelle Wheat, AustraliaJenny M. Wilkinson, AustraliaD. R. Williams, Republic of KoreaChristopher Worsnop, Australia

Haruki Yamada, JapanNobuo Yamaguchi, JapanEun J. Yang, Republic of KoreaJunqing Yang, ChinaLing Yang, ChinaKen Yasukawa, JapanAlbert S. Yeung, USAArmando Zarrelli, ItalyChris Zaslawski, AustraliaRuixin Zhang, USA

Contents

Current Development and Research in Traditional Chinese NonpharmacologicTherapy for PainFan-Rong Liang, Jianping Chen, Xin Gao, Richard E. Harris, and Bai-Yun ZengVolume 2016, Article ID 4657572, 1 page

Acupuncture for Lateral Epicondylitis: A Systematic ReviewHongzhi Tang, Huaying Fan, Jiao Chen, Mingxiao Yang, Xuebing Yi, Guogang Dai, Junrong Chen,Liugang Tang, Haibo Rong, Junhua Wu, and Fanrong LiangVolume 2015, Article ID 861849, 13 pages

Sharp-Hook Acupuncture (Feng Gou Zhen) for Patients with Periarthritis of Shoulder: A RandomizedControlled TrialLaixi Ji, Haijun Wang, Yuxia Cao, Ping Yan, Xiaofei Jin, Peirui Nie, Chaojian Wang, Rangqian Li,Chunlong Zhang, Mingxiao Yang, and Jie YangVolume 2015, Article ID 312309, 8 pages

Warm Needling Therapy and Acupuncture at Meridian-Sinew Sites Based on the Meridian-SinewTheory: Hemiplegic Shoulder PainHong Zhao, Wenbin Nie, Yuxiu Sun, Sinuo Li, Su Yang,Fanying Meng, Liping Zhang, Fang Wang, and Shixi HuangVolume 2015, Article ID 694973, 8 pages

Pain-Induced Pulsograph Changes in Patients with Primary Dysmenorrhea: A Pilot StudyWan-hong Chen, Yan Zhao, Chang-chun Zeng, Dao-ning Zhang, Yan-ping Wang, Ling Tang,Xiao-mei Zhang, and Tian-fang WangVolume 2015, Article ID 385136, 7 pages

Short-Term Effect of Laser Acupuncture on Lower Back Pain: A Randomized, Placebo-Controlled,Double-Blind TrialJae-Young Shin, Boncho Ku, Jaeuk U. Kim, Yu Jung Lee, Jae Hui Kang, Hyun Heo, Hyo-Joon Choi,and Jun-Hwan LeeVolume 2015, Article ID 808425, 8 pages

EditorialCurrent Development and Research in Traditional ChineseNonpharmacologic Therapy for Pain

Fan-Rong Liang,1 Jianping Chen,2 Xin Gao,3 Richard E. Harris,4 and Bai-Yun Zeng5

1Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan 610072, China2University of Hong Kong, Hong Kong3University of Pennsylvania, Philadelphia, PA, USA4University of Michigan, Ann Arbor, MI, USA5King’s College London, London, UK

Correspondence should be addressed to Fan-Rong Liang; [email protected] and Jianping Chen; [email protected]

Received 31 December 2015; Accepted 3 January 2016

Copyright © 2016 Fan-Rong Liang et al.This is an open access article distributed under theCreativeCommonsAttribution License,which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Pain is a common symptom of disease. According to theMedical Expenditure Panel Survey (MEPS), about 100millionadults in the United States were affected by chronic painin 2008. The annual cost spent on curing pain was greaterthan the annual costs of treating heart disease, cancer, anddiabetes in 2010. With the rapid development of medicine,there are a lot of approaches and medication for relievingpain used in clinic. However, these therapeutic approachesare not always effective and the clinical outcomes as shownin survival rates are still poor. More importantly, there arelots of side effects about these approaches. Seeking innovativetherapeutic approaches to improving the outcome of paintreatment is therefore of timely importance. Complementaryand alternative medicine (CAM) has attracted much atten-tion as innovative approaches, especially traditional Chinesenonpharmacologic. TraditionalChinesemedicine (TCM)haslong history in treating pain with good clinical experiences,and a lot of therapeuticmethods without pharmacologic havebeen used in treating pain so far, including acupuncture(针灸), tuina (推拿), scrapping (刮痧), cupping (拔罐), andelectroacupuncture (電針). In order to find the scientificevidences and convincing data, an increasing number ofscholars and research teams focus on traditional Chinesenonpharmacologic to cure pain. The research area is broad,from use of traditional approaches to approaches which com-bine traditional Chinese and modern technology, from basicresearch to clinical trial. Some exciting outcomes and recog-nized conclusions have emerged. Therefore, giving attentionto this issue is very significant as it provides the necessary

platform for improving and communicating. It is also a goodway for the researchers to understand the development ofthis specific area and to promote the sustainability of researchin this international background. In conclusion, developingstrategy of nonpharmacologic therapy for pain relief is anexploring and creative activity. It will not only bring about thediscovery of new anticancer drugs with lesser or even no sideeffects, but also make contributions to the globalization andmodernization of traditional Chinese medicine. Meanwhile,the great progress of traditional and modern approaches forpain will be beneficial for patients who suffer from pain ofdifferent kinds across the globe.

Fan-Rong LiangJianping Chen

Xin GaoRichard E. Harris

Bai-Yun Zeng

Hindawi Publishing CorporationEvidence-Based Complementary and Alternative MedicineVolume 2016, Article ID 4657572, 1 pagehttp://dx.doi.org/10.1155/2016/4657572

http://dx.doi.org/10.1155/2016/4657572

Review ArticleAcupuncture for Lateral Epicondylitis: A Systematic Review

Hongzhi Tang,1 Huaying Fan,2 Jiao Chen,2 Mingxiao Yang,2 Xuebing Yi,1 Guogang Dai,1

Junrong Chen,1 Liugang Tang,1 Haibo Rong,1 Junhua Wu,1 and Fanrong Liang2

1Sichuan Orthopaedic Hospital, Chengdu, Sichuan 610041, China2Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan 610075, China

Correspondence should be addressed to Fanrong Liang; [email protected]

Received 27 August 2015; Accepted 29 November 2015

Academic Editor: Christopher Zaslawski

Copyright © 2015 Hongzhi Tang et al. This is an open access article distributed under the Creative Commons Attribution License,which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Objective. This systematic review aimed to assess the effectiveness and safety of acupuncture for lateral epicondylitis (LE).Methods.Seven databases and the WHO International Clinical Trials Registry Platform Search Portal were searched to identify relevantstudies. The data were extracted and assessed by two independent authors, and ReviewManager Software (V.5.3) was used for datasynthesis with effect estimate presented as standard mean difference (SMD) and mean difference (MD) with a 95% confidenceinterval. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) was used to assess the level ofevidence. Results. Four RCTs with 309 participants were included with poor methodological quality. Participants who receivedacupuncture and acupuncture plus moxibustion with material insulation were likely to have an improvement in elbow functionalstatus and/or myodynamia. The overall quality rated by GRADE was from very low to low. Two studies reported that the needlepain would be the main reason for the dropout. Conclusion. For the small number of included studies with poor methodologicalquality, no firm conclusion can be drawn regarding the effect of acupuncture of elbow functional status and myodynamia for LE.This trial is registered with CRD42015016199.

1. Introduction

Lateral epicondylitis (LE), also known as tennis elbow, isupper limbs associated musculoskeletal disorder and canbe responsible for loss of function of the affected limband substantial pain, which can have a major impact onpatient’s social and professional life [1]. It is estimated thatthe prevalence of LE ranges from 1% to 3% in the overallpopulation [2], mainly occurring in those aged 45–54 years[3]. Activities that involve excessive and repetitive use of theforearm extensor, such as typing, tennis, badminton, andmanual work, may cause LE [4]. The principal cause of LE isthe degeneration of the proximal wrist extensor tendons [5].

LE not only is a major problem that causes prolongedrecovery of functional disability and long-time pain thatimpact patient’s daily life, but also produces a heavy economicburden as lost workdays and, in some patients, inability towork may last for several weeks [6, 7]. While a number oftreatment methods, such as nonsteroidal anti-inflammatorydrugs (NSAIDs), corticosteroid injections, exercise and

mobilization, extracorporeal shock wave therapy, orthoses,and surgery, are used for LE, the lines of evidence of theeffectiveness and safety of these therapy methods still remainuncertain [8–13].

As acupuncture is a green, simple, inexpensive, andhelpful treatment which has been widely practiced in Chinaand increasingly used in someWestern countries, such as theUnite States, it has been accepted for treatingmusculoskeletaldisease, especially for the functional disability and painsymptoms [14]. In recent years, a number of clinical trialshave been conducted to assess the effectiveness and safety ofacupuncture therapy for LE.

There were five systematic reviews that have been pub-lished during the last few years for assessing the effectivenessand safety of acupuncture for LE by evaluating the painchanges, but none of them draw a definitive conclusion onwhether acupuncture is effective for LE or not.The systematicreview published in 2002 by Green et al. [15] on lateralepicondylitis did not draw a conclusion on whether theacupuncture is effective for LE or not because of the small

Hindawi Publishing CorporationEvidence-Based Complementary and Alternative MedicineVolume 2015, Article ID 861849, 13 pageshttp://dx.doi.org/10.1155/2015/861849

http://dx.doi.org/10.1155/2015/861849

2 Evidence-Based Complementary and Alternative Medicine

number of included trials and problems with methodologyof the included trials, and the systematic review publishedin 2008 by Buchbinder et al. [16] also did not draw aspecific conclusion because they thought there is conflictingevidence about the value of acupuncture for LE. However,the systematic review published in 2004 by Trinh et al. [17]suggested that acupuncture is effective for short-term painrelief for LE pain, and another systematic review publishedin 2005 by Bisset et al. [18] suggested that acupuncture iseffective over placebo as treatment for LE in short-termoutcomes, and the systematic review published by Gadau etal. in 2014 [19] also showed that acupuncture may be effectivein the relief of LE pain up to a period of six months. Besides,although the systematic reviews published by Buchbinder etal. [16] and Gadau et al. [19] have also assessed the functionalimprovement or arm strength of LE, the conclusion stillremains unclear because there was only one RCT includedby assessing the functional improvement in review publishedby Buchbinder et al. and the author did not pool-analyze theincluded studies in the review published by Gadau et al.

Therefore, we can see in these systematic reviews thatacupuncture has some effect on treating LE pain, but whatremains unclear is whether acupuncture is effective andsafe in improving the functional disability and changing themyodynamia, which seems to be important to improvingpatient’s quality of life, or not.Thus,we decided to conduct thelatest systematic review by evaluating the elbow functionalstatus and myodynamia changes of the included trials toassess the effectiveness and safety of acupuncture for LE.

2. Method and Analysis

2.1. Search Method. The following 7 databases were elec-tronically searched from their inception to 2015: EMBASE,PubMed, the Cochrane Library, China National KnowledgeInfrastructure (CNKI), Chinese Scientific Journal Database(VIP database), Wanfang Database, and Chinese BiomedicalLiterature Database (Sinomed). For the last four Chinesedatabases, we only included the researches published oncore journals, such as Chinese Acupuncture and Moxibus-tion. The search terms consisted of four parts: acupuncture(acupuncture, electroacupuncture, warm acupuncture, nee-dle acupuncture, and manual acupuncture), LE (lateral epi-condylitis, tennis elbow, lateral epicondyle, external humeralepicondylitis, and lateral humeral epicondylitis), and ran-domized controlled trial. The detailed search strategies arepresented in the Appendix.

Besides, we also searched theWHOInternational ClinicalTrials Registry Platform Search Portal that contains CurrentControlled Trials, ClinicalTrials.gov, and Chinese ClinicalTrial Register for ongoing or recently completed studies byusing simple search combining acupuncture and LE.

2.2. Inclusion Criteria

2.2.1. Type of Studies. All randomized controlled trials(RCTs) involving acupuncture for treating LE were included.Completed or ongoing trials were included in this review, aswell as trials using only the two parallel designs.

2.2.2. Type of Participants. Adult participants (≥18 years old)presenting with LE were included regardless of sex, race, oreducational and economic status.

2.2.3. Types of Interventions. Interventions in the treatmentgroup included acupuncture, electroacupuncture, warmacupuncture, needle acupuncture, and manual acupuncture.Controlled interventions with sham acupuncture, placebocontrol, no treatment/waiting list control, or active treatment(e.g., nonsteroidal anti-inflammatory drugs and/or localinjection of corticosteroids) were included. RCTs evaluatingacupuncture combined with another treatment comparedwith that other treatment alone will also be included.

2.2.4. Types of Outcome Measures. Studies that reported atleast one clinical outcome related to LEwere included. Studiesreporting only physiological or laboratory parameters wereexcluded. The primary outcome was the elbow functionalstatus. The secondary outcome was the myodynamia andadverse events.

2.3. Exclusion Criteria

2.3.1. Other Types of Studies. Nonrandomized controlledtrials, randomized crossover trials, retrospective studies, casestudies, and review studies were excluded.

2.3.2. Other Participants. Participants with severe physical ormental disease were excluded.

2.3.3. Other Types of Interventions. We did not include trialsin which points were stimulated without needle insertion(such as via laser stimulation, acupressure, or transcutaneouselectrical nerve stimulation). Besides, RCTs that comparedifferent forms of acupuncture or herbal medicine wereexcluded.

2.4. Study Identification and Data Extraction. Two reviewers(Hongzhi Tang andHuaying Fan) independently assessed theeligibility of the searched studies. The full-text articles thatmet the inclusion criteria were obtained, and the relevant ref-erences were retrieved according to predefined eligibility cri-teria.Thedata has been extracted by two reviewers (JiaoChenand Huaying Fan) independently using a specially designedextraction form developed according to the Cochrane Hand-book. The following factors were included in the dataextraction form: participants’ characteristics, study methods,interventions, and outcomes. We resolved any disagreementsof study identification and data extraction by discussion andadjudication with a third reviewer (Hongzhi Tang). If anydata were insufficient or unclear, the first or correspondingauthor for the study concernedwould be contacted via E-mailor telephone to provide additional information.

2.5. Risk of Bias of the Included Studies. Two reviewers(Hongzhi Tang and Jiao Chen) assessed the included studiesfor bias risk according to the Cochrane Collaboration Riskof Bias Tool based on the following six separate domains:

Evidence-Based Complementary and Alternative Medicine 3

random sequence generation (selection bias), allocation con-cealment (selection bias), blinding of participants and per-sonnel (performance bias), blinding of outcome assessment(detection bias), incomplete outcome data (attrition bias),and selective reporting (reporting bias). The assessmentswere categorized into three levels of bias: low risk, high risk,or unclear risk.

2.6. Data Synthesis. Meta-analysis was done by using ReviewManager Software (V.5.3) developed by the Cochrane Col-laboration. Trials are combined according to the type ofintervention, type of outcome measure, and control. Forthe continuous data, the mean difference (MD) with 95%confidence intervals was used with random-effects model.For different studies assessed the elbow functional status andmyodynamia in a variety of ways, according to the CochraneHandbook, the standardized mean difference (SMD) wasused to standardize the results of the studies to a uniformscale before they were combined. Heterogeneity among theincluded studies was assessed using chi-square and 𝐼2 test. 𝐼2values indicate the degree of statistical heterogeneity. When𝑃 > 0.1, it was considered that there was no statisticalheterogeneity among studies; if 𝑃 ≤ 0.1, it was inverse.𝐼2 values less than 50% were accepted as homogeneous.If substantial heterogeneity was detected, we explored thereason for heterogeneity.

2.7. Quality of Evidence. We used the Grading of Rec-ommendations Assessment, Development, and Evaluation(GRADE), which is a method of grading the level of evidenceand is developed by the GRADEWorking Group [24, 25], toassess the quality of evidence, and the GRADEpro software(version 3.6 for Windows, Grade Working Group) was used.

3. Results

3.1. Study Identification. The flow of the literature search andselection process is shown in Figure 1. A total of 344 recordsand two registered trials were identified from the includeddatabases. 75 duplicate records were excluded, among which74 records were excluded by reading the title and abstract,and one record was excluded by reading the full article.264 articles were excluded (including one registered trial)because they did not meet the inclusion criteria; one articlewas further excluded because the data of the study cannot becollected from the article and there was no response from thecorresponding author. Two studies about acupuncture of LEare ongoing. Finally, four studies [20–23] were included andtwo ongoing trials [26, 27] were described in this systematicreview.

3.2. Characteristics of the Included Studies. Characteristicsof the methods, participants, intervention, and outcomemeasures of all included studies and ongoing studies wereshown in Tables 1 and 2 separately. Among the four includedstudies, there were two conducted in China [22, 23], andtwo were conducted in Germany [20, 21]. In total, there were309 patients who participated in the included studies, among

which there were 155 patients in the acupuncture group and154 patients in the controlled group.Their age ranged from 18years to 70 years, and the duration of the LE was varied fromone month to 15 months. All studies included both men andwomen. Two trials [20, 21] compared acupuncture with shamacupuncture, one trial [22] compared electroacupunctureplus moxibustion with material insulation with blockagetherapy, and one trial [23] compared electroacupunctureplus blockage therapy with blockage therapy. In these trials,frequency of acupuncture was at least 20min per treatmentand 3 treatments. Four studies [20–23] reported outcomesincluding the functional status and pain change; three studies[20, 21, 23] reported the myodynamia change as outcome.

3.3. Methodological Quality of Included Studies. Themethod-ological quality of included studies was assessed by riskof bias, presented in Figures 2 and 3. All of the includedstudies reported randomization allocation. One study [20]described the method of random sequence generation whichwas a list random number prepared by the Department ofBiostatistics of Hannover Medical School. One study [23]reported the randomization allocation by using MicrosoftOffice Excel, and another two studies [21, 22] used therandomization allocation method according to sequence ofpatients’ attendance. All of the four studies did not describethe allocation concealment in sufficient detailed ways. Onlyone study [21] reported the blinding of the participants, andtwo studies [20, 21] reported the blinding of the outcomeassessment, in which one [20] was assessed by an assessorwho had no knowledge of acupuncture and another one [21]was assessed by a blinded study nurse. Two trials [21, 22] hadlow risk of attrition bias, which reported that no participantsdropped out or were excluded from the primary analysis, andanother two trials [20, 23] also had low risk for reportingthe number of dropouts. All of the relevant outcomes werereported in detail in the four trials [20–23], which had lowrisk of reporting bias. None of the four trials [20–23] reportedthe source of financial support, declared that no financialinterests exist, or mentioned that the research was approvedby ethics committee.

3.4. Measures of Effect

3.4.1. Elbow Functional Status

Acupuncture versus Sham Acupuncture. The clinical hetero-geneity of two trials [20, 21] comparing acupuncture withsham acupuncture is considerable. Pooled analysis showedno statistical heterogeneity among the studies (𝑃 > 0.1)and was statistically significant (SMD −0.56, 95% CI −0.98to −0.15, 𝑃 = 0.008), which suggested that the effectivenessof acupuncture on treating function disability of LE is betterthan sham acupuncture (see Figure 4).

Acupuncture PlusMoxibustionwithMaterial Insulation versusBlockageTherapy. Only one trial [22] compared the acupunc-ture plusmoxibustionwithmaterial insulationwith acupunc-ture alone (MD 12.10, 95% CI 10.65 to 13.55). The resultshowed that acupuncture plus moxibustion with material


(i) PubMed: 41(ii) EMBASE: 46(iii) Cochrane Library: 12(iv) Sinomed: 31(v) VIP database: 8(vi) CNKI: 38(vii) Wanfang Database: 167

(i) Current Controlled Trials: 1(ii) ClinicalTrials.gov: 1(iii) Chinese Clinical Trial Register: 0

A total 344 records and 2 registeredtrials

271 records after duplicates are removed

74 duplicate records were excluded by reading the title

and abstract1 duplicate record was

excluded by reading full article

7 records screened and assessed foreligibility

6 studies included in systematic review(i) Included studies: 4(ii) Ongoing studies: 2

264 articles were excluded because they did not

meet the inclusion criteria

1 eligibility article was further excluded because the data of the study cannot be obtained although the corresponding

author was contacted via E-mail

Figure 1: Flow diagram for search and selection of the included studies.

Low risk of biasUnclear risk of biasHigh risk of bias

5025 75 1000(%)

Random sequence generation (selection bias)Allocation concealment (selection bias)

Blinding of participants and personnel (performance bias)Blinding of outcome assessment (detection bias)

Incomplete outcome data (attrition bias)Selective reporting (reporting bias)

Figure 2: Risk of bias graph: review authors’ judgements about each risk of bias item presented as percentages across all included studies.

insulation is superior for improving the function disability toacupuncture alone (see Figure 5).

Acupuncture Plus Blockage Therapy versus Blockage Therapy.One trial [23] revealed no statistically significant differencebetween acupuncture plus blockage therapy and blockagetherapy alone (MD 2, 95% CI −0.98 to 4.98), which demon-strated that acupuncture plus blockage therapy was not

superior to blockage therapy alone in improving functiondisability of LE (see Figure 6).

3.4.2. Myodynamia

Acupuncture versus Sham Acupuncture. Two trials [20, 21]were included to pool-analyze the change in myodynamia,which showed that acupuncture group had better effect than


Table1:Th

echaracteristicso

fincludedstu

dies

inthissyste

maticreview

.

Author,year

Metho

dParticipants

total(𝑇/𝐶)

Mean(SD)/rangea

geInterventio

nAc

upun

cture

points

Frequencyanddu

ratio

nof

acup

unctureintervention

Outcomes

Treatm

ent

Con

trol

Treatm

ent

Con

trol

Fink

etal.,

2002

[20]

RCT

45(23/22)52.5±8.751.6±10.0

Realacup

uncture

Sham

acup

uncture

Ashi,LI10,LI11,

LU5,LI4,and

SJ5

25min/treatm

ent;10

treatments,w

ith2

treatmentsperw

eek

(1)M

axim

almuscle

strength

(2)V

AS

(3)D

ASH

Irnich

etal.,

2003

[21]

RCT

50(25/25)

31–70

38–6

5Re

alacup

uncture

Sham

acup

uncture

LI4,LI10,SI3,

SJ5,andGB3

425

min/treatm

ent;3

treatmentswith

in10

days

(1)P

PT(2)G

S(3)IP

Jiang

etal.,

2005

[22]

RCT

128(64/64

)42.14±5.6241.68±5.76

Electro

acup

uncture

plus

moxibustio

nwith

material

insulation

Blockage

therapy

LI4,LR

320

min/treatm

ent;10

treatmentswith

in5

treatmentsperw

eek

Elbo

wfunctio

nstatus

Lietal.,2014

[23]

RCT

86(43/43)

18–22

18–22

Electro

acup

uncture

plus

massage

and

blockage

therapy

Blockage

therapy

Ashi,LI11,LI12,

LI10,SJ5,and

LI4

30min/treatm

ent;on

ceper

dayfor10days

(1)V

AS

(2)G

SI(3)M

EPS

VAS:VisualAnalogS

cale;D

ASH

:disa

bilitieso

fthe

arm,sho

ulder,andhand

;PPT

:pressurep

ainthreshold;GS:gripstr

ength;IP:im

pairm

entcausedby

pain;G

SI:grip

strengthindex;MEP

S:MayoE

lbow

Perfo

rmance

Score.


Table2:Th

echaracteristicso

fongoing

studies

inthissyste

maticreview

.

Title

Cou

ntry

Trialregistratio

nInclu

sioncriteria

Exclu

sioncriteria

Metho

dParticipantstotal

Interventio

nOutcomes

Treatm

ent

Con

trol

Prim

ary

outcom

eSecond

outcom

e

Acup

uncturefor

Lateral

Epicon

dylitis(Tennis

Elbo

w):Stud

yProtocol

fora

Rand

omized

Practitioner-A

ssessor

Blinded,Con

trolled

PilotC

linicalTrial

Korea

ClinicalRe

search

Inform

ationService

(CRIS),R

epub

licof

Korea:KC

T000

0628

(1)Ind

ividualsbetweenthea

ges

of19

and65

yearsw

ithlateral

epicon

dylitison

onea

rmand

pain

persistingfora

tleast4

weeks;(2)ind

ividualswith

tend

ernesslim

itedto

thee

lbow

jointand

surrou

ndingarea;(3)

individu

alsreportin

gpain

underresisted

extensionof

the

middlefi

nger

andwris

t;(4)

individu

alsw

ithan

averagep

ain

of40

ormore(0–

100)

onthe

VisualAnalogueS

cale(VAS)

inthew

eekpriortothes

creening

visit;(5)ind

ividualswho

volunteeredto

participateinthe

study

andwho

signedac

onsent

form

(1)Ind

ividualswho

seradiologicalexam

inations

show

abno

rmalities

such

ascalcificatio

n,arthritis,

and

inflammatoryarthropathyof

thee

lbow

joint;(2)ind

ividuals

with

ahistoryof

trauma,

ligam

entd

amage,fracture,

tumor,orsurgery

ofthee

lbow

joint;(3)ind

ividualswho

have

been

diagno

sedwith

ortre

ated

forc

ervicalradiculop

athy

orherniatio

nof

intervertebral

disc;(4)ind

ividualswho

have

received

injections

forlateral

epicon

dylitisdu

ringthelast6

mon

ths;(5)ind

ividualswho

have

received

treatmentssuch

asno

nsteroidal

anti-inflammatorydrugs

(NSA

IDs),acupu

ncture,and

physiotherapyforlateral

epicon

dylitisdu

ringthelast2

weeks;(6)ind

ividualsjudged

bythep

ersonin

charge

ofthe

clinicaltria

lasu

nsuitablefor

participation,such

asthosew

ithmentald

isorders,thosew

hoare

pregnant,ortho

sethathave

othera

cuteor

chronicd

isorders

RCT

45Ipsilateral

acup

uncture

grou

p

Con

tralateral

acup

uncture

grou

p

Con

trol

grou

p

TheV

isual

AnalogScale

(VAS)

at4weeks

(1)Th

eVisu

alAnalogScale

(VAS)

at8and12

weeks;(2)the

patie

nt-rated

tenn

iselb

owevaluatio

n(PRT

EE);(3)

pain-

free/maxim

umgrip

strength;(4)

pressure

pain

threshold;(5)

clinically

relevant

improvem

ent,

patie

ntglob

alassessment,and

EuroQolat4,8,

and12

weeks

ClinicalCom

parativ

eEff

ecto

fPhysio

therapy

orAc

upun

cture

Treatm

ento

fLateral

Epicon

dylitis:

ARa

ndom

ized

Con

trolled

PilotT

rial

Norway

ClinicalTrials.gov:

NCT

02321696

(1)L

ateralepicon

dylitis(LE)

(duration:>2weeks);(2)

unilaterallocalization;

(3)

individu

alsw

ithaveragep

ainof

NRS

4or

high

erdu

ringthelast

weekpriortoscreening;(4)a

gebetween18

and67

years;(5)

writteninform

edconsent

(1)C

ortic

osteroid

injections

durin

gthelast4

weeks;(2)

diseases

ofthec

entralor

perip

heraln

ervous

syste

m;(3)

inflammatoryrheumatic

diseases;(4)radioulnaro

rradioh

umeralosteoarthritis;(5)

unwillingn

esstoparticipate

RCT

36Ac

upun

cture

andeccentric

exercise

Physiotherapy

andeccentric

exercise

Watchful

waitin

gand

eccentric

exercise

Elbo

wpain

onNum

ericRa

ting

Scale(0–

10)

(1)Th

edisabilitieso

fthe

arm,sho

ulder,

andhand

(quick-D

ASH

);(2)q

ualityof

life

byEQ

-5D;(3)

sicklistin

g;(4)

patie

nts

satisfaction;

glob

alperceived

effectand

satisfactionwith

treatment;(5)u

seof

analgesic

s;(6)

numbero

ftre

atment

sessions


Random sequence generation (selection bias)

Blinding of outcome assessment (detection bias)

Incomplete outcome data (attrition bias)

Selective reporting (reporting bias)

Allocation concealment (selection bias)

Blinding of participants and personnel (performance bias)

Li et

al.,

2014

Jiang

et al

., 20

05

Irni

ch et

al.,

2003

Frin

k et

al.,

2002

+

+

+

+

+

+

+

++

+

+

+

+

−−

? ?

??

? ?

? ?

?

Figure 3: Risk of bias summary: review authors’ judgments about each risk of bias item for each included study.

Study or subgroup

Frink et al., 2002Irnich et al., 2003

Total (95% CI)

Mean−26.94−4.31

SD16.12.89

Total2226

48

Mean−21.87−2.04

SD14.862.89

Total2025

45

Weight

46.7%53.3%

100.0%

IV, fixed, 95% CI−0.32 [−0.93, 0.29]−0.77 [−1.34, −0.20]

−0.56 [−0.98, −0.15]

Sham acupunctureAcupuncture Std. mean difference Std. mean differenceIV, fixed, 95% CI

AcupunctureTest for overall effect: Z = 2.64 (P = 0.008)Heterogeneity: 𝜒2 = 1.13, df = 1 (P = 0.29); I2 = 11%

0 50 100−50−100Sham acupuncture

Figure 4: The effect of acupuncture versus sham acupuncture on elbow functional status.

Study or subgroup

Jiang et al., 2005

Total (95% CI)Heterogeneity: not applicable

Mean44.92

SD4.09

Total64

64

Mean32.82

SD4.29

Total64

64

Weight

100.0%

100.0%

IV, fixed, 95% CI12.10 [10.65, 13.55]

12.10 [10.65, 13.55]

Mean difference Mean differenceIV, fixed, 95% CI

Acupuncture plus moxibustionwith material insulation

Test for overall effect: Z = 16.33 (P < 0.00001) 0 50 100−50−100Blockage therapy

Blockage therapy

Acupuncture plusmoxibustion with

material insulation

Figure 5: The effect of acupuncture plus moxibustion with material insulation versus blockage therapy on elbow functional status.

Study or subgroup

Li et al., 2014

Total (95% CI)Heterogeneity: not applicable

Mean20

SD6.3

Total40

40

Mean18

SD7.25

Total40

40

Weight

100.0%

100.0%

IV, fixed, 95% CI2.00 [−0.98, 4.98]

2.00 [−0.98, 4.98]

Mean difference Mean differenceIV, fixed, 95% CI

Acupuncture plusblockage therapy

Acupuncture plusblockage therapyBlockage therapy

Test for overall effect: Z = 1.32 (P = 0.19)0 50 100−50−100

Blockage therapy

Figure 6: The effect of acupuncture plus blockage therapy versus blockage therapy on elbow functional status.


Study or subgroup

Frink et al., 2002Irnich et al., 2003

Total (95% CI)

Mean52.4

21.54

SD49.3

28.27

Total2226

48

Mean36.58.53

SD46.7317.9

Total2025

45

Weight

45.7%54.3%

100.0%

IV, fixed, 95% CI0.33 [−0.29, 0.93]0.54 [−0.02, 1.10]

0.44 [0.03, 0.85]

Sham acupuncture Acupuncture Std. mean difference Std. mean differenceIV, fixed, 95% CI

AcupunctureTest for overall effect: Z = 2.10 (P = 0.04)Heterogeneity: 𝜒2 = 0.26, df = 1 (P = 0.61); I2 = 0%

0 50 100−50−100Sham acupuncture

Figure 7: The effect of acupuncture versus sham acupuncture on elbow myodynamia.

Study or subgroup

Li et al., 2014

Total (95% CI)

Heterogeneity: not applicable

Mean

21

SD

6.94

Total

40

40

Mean

19

SD

7.23

Total

40

40

Weight

100.0%

100.0%

IV, fixed, 95% CI

2.00 [−1.11, 5.11]

2.00 [−1.11, 5.11]

Blockage therapy Mean difference Mean differenceIV, fixed, 95% CI

Test for overall effect: Z = 1.26 (P = 0.21) Acupuncture plusblockage therapy

Acupuncture plusblockage therapy

0 50 100−50−100Blockage therapy

Figure 8: The effect of acupuncture plus blockage therapy versus blockage therapy on elbow myodynamia.

sham acupuncture (SMD0.44, 95%CI 0.03 to 0.85,𝑃 = 0.04),and the statistical heterogeneitywas not significant (𝑃 = 0.61)(see Figure 7).

Acupuncture Plus Blockage Therapy versus Blockage Therapy.One trial [23] showed no statistically significant differencebetween acupuncture plus blockage therapy and blockagetherapy alone (MD 2, 95% CI −1.11 to 5.11, 𝑃 = 0.21) (seeFigure 8).

3.5. Adverse Events. Of the four studies, three studies [20, 21,23] reported the adverse events. One study [20] reported thatno serious adverse event was observed during the study. Theother two studies [20, 22] reported that the pain would be themain reason for the dropout.

3.6. Quality of Evidence. The quality of evidence evaluatedusing the Grading of Recommendations Assessment, Devel-opment, and Evaluation (GRADE) system was from very lowto low (Table 3). All of the studies reported the randomizationmethod, but two of the studies [21, 22] used the wrongrandom method, according to the sequence of attendance.Besides, all of the studies did not describe the methodof allocation concealment in a detailed way, and only onestudy [21] reported the blinding of the participants, whichdowngraded the outcomes. In addition, the small number ofparticipants of all outcomes also downgraded all outcomes.

4. Discussion

Comprehensive search was conducted through 7 electronicdatabases and WHO International Clinical Trials Registry

Platform Search Portal for acupuncture in treating LE. Thestudies identification, data extraction, and analysis werecarried out independently by two review authors. In thissystematic review, we included a total of four randomizedcontrolled trials [20–23] with 309 participants suffering fromLE. Of all studies, two studies [20, 21] were designed tocompare acupuncture with sham acupuncture, one study [22]compared acupuncture combined with moxibustion withmaterial insulation to blockage therapy, and another study[23] was designed to compare acupuncture plus blockagetherapy with blockage therapy. In the outcomes, two studies[20, 21] that compared acupuncture with sham acupunctureshowed that acupuncture significantly improves elbow func-tional disabilities and myodynamia. Besides, one trial [22]also showed that electroacupuncture combined with moxi-bustion with material insulation improved elbow functionaldisabilities and myodynamia when compared with block-age therapy. However, when combining electroacupuncturewith blockage therapy to compare with blockage therapyalone, there is no change in elbow functional status andmyodynamia. Up to the present, there were five systematicreviews that have assessed acupuncture for LE. All of thesystematic reviews have assessed the effectiveness and safetyof acupuncture for LE by evaluating the pain and suggestedthat acupuncture has some effect on treating elbow pain.Although there are two systematic reviews that have assessedthe strength of arm and functional status of arms, they did notdraw a definitive conclusion onwhether acupuncture is effec-tive for LE or not. Therefore, we conducted this systematicreview to assess the effectiveness and safety of acupuncturefor LE on elbow functional disability and myodynamia. Inthe present review, we analyzed four studies accounting for

Evidence-Based Complementary and Alternative Medicine 9Ta

ble3:Th

equalityof

evidence.

(a)Ac

upun

cturev

ersussham

acup

uncture

Qualityassessment

Num

bero

fpatients

Effect

Quality

Impo

rtance

Num

bero

fstu

dies

Design

Risk

ofbias

Inconsistency

Indirectness

Imprecision

Other

considerations

Acup

uncture

Sham

acup

uncture

Relativ

e(95%

CI)

Absolute

Functio

n(fo

llow-up:14–6

0days,m

easuredwith

scale,rangeo

fscores:10–20,bette

rind

icated

bylowe

rvalues)

2Ra

ndom

ized

trials

Serio

us1

Noserio

usinconsistency

Noserio

usindirectness

Serio

us2

Non

e48

45—

SMD0.56

lower

(0.98

to0.15

lower)

Low

Critical

Myodynamia(fo

llow-up:4to

60days,m

easuredwith

scale,rangeo

fscores:10–20,bette

rind

icated

byhigh

ervalues)

2Ra

ndom

ized

trials

Serio

us1

Noserio

usinconsistency

Noserio

usindirectness

Serio

us2

Non

e48

45—

SMD0.44

high

er(0.53

to0.85

high

er)

Low

Critical

1Th

etria

lusedthew

rong

rand

ommetho

d,which

accordingto

sequ

ence

ofattend

ance

andthem

etho

dof

allocatio

nconcealm

entisn

otdescrib

ed.

2To

talp

opulationsiz

eislessthan40

0,andeffectsizeisc

onsid

ered

asmalleffect;the

uppero

rlow

erconfi

dencelim

itcrossesa

neffectsizeo

f0.5in

either

direction.

(b)Ac

upun

cturep

lusm

oxibustio

nwith

materialinsulationversus

blockage

therapy

Qualityassessment

Num

bero

fpatients

Effect

Quality

Impo

rtance

Num

bero

fstu

dies

Design

Risk

ofbias

Inconsistency

Indirectness

Imprecision

Other

considerations

Acup

uncture

plus

moxibustio

nwith

material

insulation

Blockage

therapy

Relativ

e(95%

CI)

Absolute

Functio

n(m

easuredwith

scales,range

ofscores:10–

20,betterind

icated

byhigh

ervalues)

1Ra

ndom

ized

trials

Very

serio

us1

Noserio

usinconsistency

Noserio

usindirectness

Serio

us2

Non

e64

64—

MD12.10

high

er(10.65

to13.55

high

er)

Very

low

Critical

1Th

emetho

dof

allocatio

nconcealm

entisn

otdescrib

ed.

2To

talp

opulationsiz

eislessthan40

0,andeffectsizeisc

onsid

ered

asmalleffect;the

uppero

rlow

erconfi

dencelim

itcrossesa

neffectsizeo

f0.5in

either

direction.

(c)Ac

upun

cturep

lusb

lockagetherapy

versus

blockage

therapy

Qualityassessment

Num

bero

fpatients

Effect

Quality

Impo

rtance

Num

bero

fstu

dies

Design

Risk

ofbias

Inconsistency

Indirectness

Imprecision

Other

considerations

Acup

uncture

plus

blockage

therapy

Blockage

therapy

Relativ

e(95%

CI)

Absolute

Functio

n(fo

llow-upmean:

12mon

ths,measuredwith

scales,range

ofscores:10–

20,betterind

icated

byhigh

ervalues)

1Ra

ndom

ized

trials

Serio

us1

Noserio

usinconsistency

Noserio

usindirectness

Serio

us2

Non

e40

40—

MD2high

er(0.96lower

to4.98

high

er)

Low

Critical


(c)Con

tinued.

Qualityassessment

Num

bero

fpatients

Effect

Quality

Impo

rtance

Num

bero

fstu

dies

Design

Risk

ofbias

Inconsistency

Indirectness

Imprecision

Other

considerations

Acup

uncture

plus

blockage

therapy

Blockage

therapy

Relativ

e(95%

CI)

Absolute

Myodynamia(fo

llow-upmean:

12mon

ths,measuredwith

scales,range

ofscores:10–

20,betterind

icated

byhigh

ervalues)

1Ra

ndom

ized

trials

Serio

us1

Noserio

usinconsistency

Noserio

usindirectness

Serio

us2

Non

e40

40—

MD2high

er(1.11

lower

to5.11high

er)

Low

Critical

1Th

emetho

dof

allocatio

nconcealm

entisn

otdescrib

ed.

2To

talp

opulationsiz

eislessthan40

0,andeffectsizeisc

onsid

ered

asmalleffect;the

uppero

rlow

erconfi

dencelim

itcrossesa

neffectsizeo

f0.5in

either

direction.


309 participants on elbow functional status andmyodynamia,which showed that acupuncture has some effect on elbowfunctional disability. While this finding seems promising,it should be interpreted with caution because of the smallnumber of included studies and participants. Besides, therewere no trials reporting a formal sample size calculationwhich is essential to ensure adequate statistical power.

There are still several limitations in this review. The keylimitation was the small number of the included studiesand participants, which limited the reliability of the pooledresults. Another limitation was the quality of the includedstudies. Mostly included studies were of low quality dueto no detailed definition on random sequence generation,allocation concealment, and blinding of participants andpersonnel.The low quality of the included studies also limitedthe reliability of conclusion of this review. Besides, all theincluded studies were from Germany and China, but LE is aworldwide disease. Last, because of ununiformed assessmentscale of elbow functional status and upper limbmyodynamia,even though SMD method was applied to standardize theresults of the studies to a uniform scale before they werecombined, we still cannot ignore the report bias caused bythe ununiformed assessment scale.

Thus, based on the current systematic review, no firmconclusion can be drawn regarding the effect of acupuncturefor LE. Although four randomized controlled trials wereidentified, the methodological quality of the four studies waslow due to high risk in selection bias and blinding of partici-pants and personnel, and the number of the patients recruitedin each trial was small, which limited the reliability of thepooled results. Besides, the small number of the includedstudies also makes the results of this review inconclusive. Inthe end, in order to confirm the effectiveness of acupuncturefor LE, large prospective trials with rigorous design shouldbe conducted more rigorously in the future trials and theassessment scale as well as the evaluation standard needs tobe unified from international institute of health as soon aspossible.

Appendix

A. Search Strategies

A.1. Search Strategy Used in Cochrane Library

#1 “lateral epicondyle”:ti,ab,kw#2 lateral epicondylitis:ti,ab,kw#3 “tennis elbow”:ti,ab,kw#4 external humeral epicondylitis:ti,ab,kw#5 Lateral Humeral Epicondylitis:ti,ab,kw#6 #1 or #2 or #3 or #4 or #5#7 “acupuncture”:ti,ab,kw#8 “electroacupuncture”:ti,ab,kw#9 warm acupuncture:ti,ab,kw#10 neddle acupuncture:ti,ab,kw

#11 mannual acupuncture:ti,ab,kw#12 #7 or #8 or #9 or #10 or #11#13 “controlled clinical trial”:ti,ab,kw#14 “randomised clinical trial”:ti,ab,kw#15 “randomised control trial”:ti,ab,kw#16 #13 or #14 or #15#17 “animal”:ti,ab,kw and “human”:ti,ab,kw#18 “animal”:ti,ab,kw#19 #18 not #17#20 #16 not #19#21 #6 and #12 and #20

A.2. Search Strategy Used in EMBASE

#1 lateral AND epicondylitis#2 tennis AND elbow#3 lateral AND epicondyle#4 external AND humeral AND epicondylitis#5 lateral AND humeral AND epicondylitis#6 #1 OR #2 OR #3 OR #4 OR #5#7 Acupuncture#8 electroacupuncture#9 warm AND acupuncture#10 neddle AND acupuncture#11 mannual AND acupuncture#12 #7 OR #8 OR #9 OR #10 OR #11#13 controlled AND clinical AND trial#14 randomised AND clinical AND trial#15 randomised AND control AND trial#16 #13 OR #14 OR #15#17 #6 AND #12 AND #16

A.3. Search Strategy Used in PubMed

#1 acupuncture#2 acupuncture therapy#3 manual acupuncture#4 electroacupuncture#5 acupoint#6 acupuncture[MeSH Terms]#7 acupuncture therapy[MeSH Terms]#8 acupoint[MeSH Terms]#9 #1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8#10 Tennis Elbow#11 Elbow, Tennis#12 Elbows, Tennis


#13 Tennis Elbows#14 Epicondylitis, Lateral Humeral#15 Epicondylitides, Lateral Humeral#16 Humeral Epicondylitides, Lateral#17 Humeral Epicondylitis, Lateral#18 Lateral Humeral Epicondylitides#19 Lateral Humeral Epicondylitis#20 lateral epicondylitis#21 lateral epicondyle#22 external humeral epicondylitis#23 epicondylitis#24 Tennis Elbow[MeSH Terms]#25 #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16OR #17 OR #18 OR #19 OR #20 OR #21 OR #22 OR#23 OR #24#26 randomised controlled trial#27 controlled clinical trial#28 randomized controlled trial#29 randomised#30 randomly#31 placebo#32 trial#33 randomized controlled trial[MeSH Terms]#34 #26 OR #27 OR #28 OR #29 OR #30 OR #31 OR#32 OR #33#35 (animals) AND humans#36 animals#37 #36 NOT #35#38 #34 NOT #37#39 #9 AND #25 AND #38

A.4. Search Strategy Used in Sinomed

#1 “网球肘”[不加权:扩展]#2网球肘#3肱骨外上髁炎#4 (#3) OR (#2) OR (#1)#5 “针刺疗法”[不加权:扩展]#6 “针刺穴位”[不加权:扩展]#7 “电针”[不加权:扩展]#8 “温针疗法”[不加权:扩展]#9 “针刺”[不加权:扩展]#10针刺疗法#11针刺#12电针#13温针

#14针刺穴位#15 (#14) OR (#13) OR (#12) OR (#11) OR (#10) OR(#9) OR (#8) OR (#7) OR (#6) OR (#5)#16 “随机对照试验”[不加权:扩展]#17 “随机分配”[不加权:扩展]#18随机对照试验#19随机分配#20 (#19) OR (#18) OR (#17) OR (#16)#21 (#20) AND (#15) AND (#4)#22 ((#21)) AND (人类[特征词])

Conflict of Interests

All authors declare that there is no conflict of interestsregarding the publication of this paper.

Authors’ Contribution

H. Tang and H. Fan contributed equally to the conceptionof the study. The paper was drafted by H. Tang and H. Fanand revised by J. Chen. The search strategy was developedby all authors and run by L. Tang and H. Rong, who alsoindependently screened the potential studies. J. Wu and M.Yang extracted data from the included studies, and J. Chenassessed the risk of bias and finished data synthesis. F. Liangarbitrated any disagreements and ensured that no errorsoccur during the study. Besides, H. Tang, H. Fan, J. Chen,M. Yang, F. Liang, X. Yi, G. Dai, and J. Chen contributedto the registration of this systematic review. All authors haveapproved the publication of the systematic review.

Acknowledgment

This work was supported by funds from the Science andTechnology Department of Sichuan province, Grants nos.2011SZ0302 and 2015SZ0096.

References

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Research ArticleSharp-Hook Acupuncture (Feng Gou Zhen) for Patients withPeriarthritis of Shoulder: A Randomized Controlled Trial

Laixi Ji,1 Haijun Wang,1 Yuxia Cao,2 Ping Yan,1 Xiaofei Jin,1 Peirui Nie,2 Chaojian Wang,2

Rangqian Li,2 Chunlong Zhang,2 Mingxiao Yang,3 and Jie Yang3

1Shanxi College of Traditional Chinese Medicine, Jinzhong, Shanxi 030619, China2TheThird Teaching Hospital of Shanxi College of Traditional Chinese Medicine, Jinzhong, Shanxi 030006, China3Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan 610072, China

Correspondence should be addressed to Laixi Ji; [email protected]

Received 10 August 2015; Accepted 13 October 2015

Academic Editor: Xin Gao

Copyright © 2015 Laixi Ji et al. This is an open access article distributed under the Creative Commons Attribution License, whichpermits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

The Feng Gou Zhen (sharp-hook acupuncture) as a traditional form of ancient acupuncture is said to be particularly effective formanaging periarthritis of shoulder. We conducted this randomized controlled trial to evaluate the effectiveness of Feng Gou Zhenas an add-on compared to conventional analgesics for patients with PAS. 132 patients were randomly assigned in a 1 : 1 ratio toeither a acupuncture group receiving sharp-hook acupuncture plus acupoint injection with conventional analgesics or a controlgroup. Patients from both groups were evaluated at week 0 (baseline), week 1, and week 4. The primary outcome measure was thechange from baseline shoulder pain, measured by Visual Analogue Scale at 7 days after treatment. Secondary outcome measuresinclude the (i) function of shoulder joint and (ii) McGill pain questionnaire.The results showed that patients in acupuncture grouphad better pain relief and function recovery compared with control group (𝑃 < 0.05) at 1 week after treatment. Moreover, therewere statistical differences between two groups in VAS and shoulder joint function and McGill pain questionnaire at 4 weeks aftertreatment (𝑃 < 0.05).Therefore, the sharp-hook acupuncture helps to relieve the pain and restore the shoulder function for patientswith periarthritis of shoulder.

1. Background

Periarthritis of shoulder (PAS), or, namely, the frozen shoul-der, is a common, disabling musculoskeletal disorder inmiddle-aged people. It commonly refers to a collection ofpain symptoms in shoulders, plus motor function limitation,due to soft tissue abnormalities surrounding the affectedshoulder [1]. It is mostly a aseptic inflammation of themusculoskeletal system. The PAS is prevailing in people ofthe age 40 to 60 years, and thus they were called “the forty’sshoulder.” The population incidence of PAS is 2%–5% in theUnited States [2]. In China, the PAS in urban populationaccounts for 8% and three quarters are female patients[3]. Studies also demonstrated that inadequate treatment orinappropriate treatment led to severely reduced life qualityand unsatisfactory work performance [4].

Nowadays, there are many treatment options for PAS,including intra-articular triamcinolone injection [5] andbupivacaine suprascapular nerve blocks [6]. These modern

therapies are successfully employed in clinical practice forPAS treatment. However, the treatment effects are not alwayslong-lasting and most of which disappear in 4 weeks aftertreatment approximately [7, 8]. Moreover, these treatmentoptions may be associated with severe adverse events, suchas infectious arthritis and cartilage damage, all of which mayput the patient into certain risks of disease deterioration [9].Therefore, to search for novel treatment modality is of greatsignificance for the management of PAS.

In China, acupuncture is an effective traditional thera-peutics that is originated in ancient China. During its over3000 years of history of clinical practice, acupuncture treat-ment gets developed and evolved to treat various disorders. Inrecent decades, acupuncture as a complementary and alter-native therapy has been increasingly recognized in westerncountries. Current evidence suggests that acupuncture is avalid intervention for treating pain [10, 11] andmusculoskele-tal disorders [12, 13]. There are also studies revealing that

Hindawi Publishing CorporationEvidence-Based Complementary and Alternative MedicineVolume 2015, Article ID 312309, 8 pageshttp://dx.doi.org/10.1155/2015/312309

http://dx.doi.org/10.1155/2015/312309


Figure 1: Illustration of the Feng Gou Zhen (sharp-hook needle).

acupuncture triggers the endogenous opium and cannabi-noids system to release several pain-ameliorating substancesto reduce pain [14, 15].Therefore, many PAS patients resortedto acupuncture therapy in China and other foreign countries.Though studies reported that acupuncture is effective forPAS, the strength of evidence and its recommendation isstill weak. According to a recent Cochrane systematic review,the effect of acupuncture for shoulder pain and its functionimprovement is still inconclusive. Current little evidence isunable to affirm or refute the effectiveness of acupuncture forPAS. It is of great importance to conduct a clinical trial withrigorous methodology to assess acupuncture’s effect.

Importantly, acupuncture is a complex of different nee-dling therapies. Different acupuncture modalities or equip-ment may possess different treatment powers. The Feng GouZhen (sharp-hook needle) is a modified form of ancientnine needles as recorded in the Yellow Emperor’s InternalMedicinal Cannon (as shown in Figure 1). The modificationof this form of needle is initiated by Dr. Huaitang Shi whowas a renowned acupuncturist in China, as well as the FirstDirector of the Research Center of Acupuncture in Shanxi.The design of the Feng Gou Zhen is based on the three-edge sharp needle of ancient nine needles and the adding ofcertain features of the hook needle in folks. By integratingtheir characteristics, we invented the Feng Gou Zhen device.Our clinical observation indicates that the Feng Gou Zhenis very effective for treating lots of diseases, and PAS is justone of them. In our practice, we found that one session ortwo sessions of sharp-hook acupuncture treatment relieve thepain of PAS and recovers the function of shoulder joint. But,at present there is still no randomized controlled trial eval-uating the effective of sharp-hook acupuncture for PAS. Wetherefore performed this one-center, randomized controlled,open-labeled trial to assess the effect of acupuncture as add-on for pain relief and joint function improvement in PAS.

2. Participants and Methods

2.1. Trial Design. This study is a one-center, randomized,controlled, and open-labeled trial that assesses the effectof sharp-hook acupuncture in addition to acupoint injec-tion with conventional analgesics for treating PAS. Eligiblepatients were randomly assigned to either acupuncture groupor control group in a 1 : 1 ratio.

2.2. Participants. All patients were recruited from the Anes-thesiology Center and General Medicine Department ofthe Shanxi Acupuncture Research Center between October2012 and October 2014. Shanxi Regional Ethics Review

Committee onTraditional ChineseMedicine has approved allresearch procedures (2012LC-03) and has been registered inChinese Clinical Trial Registry (ChiCTR-IOC-15006309). Allincluded participants provided their written inform consentwith signature. Patients were introduced to this trial by theirdoctors. The eligibility criteria for participants included theinclusion and exclusion criteria that were referred to in Sunet al.’s study [16] and listed as follows.

2.2.1. Inclusion. Inclusion criteria include (1) shoulder painfor at least 1 month and less than 12-month duration; (2)appreciable restriction of both active and passive motionswith abduction and flexion not exceeding 90∘ and externalrotation not exceeding 30∘; (3) pain at night, with inability tolie on the affected side; (4) age between 40 years and 65 years;(5) receiving no treatment in the last 4 weeks; (6) agreeingto cooperate with doctor’s instructions of acupuncture; (7)providing written inform consent.

2.2.2. Exclusion. Exclusion criteria include (1) history ofmajor shoulder injury or surgery; (2) clinical or radiologicalevidence of other pathologies that could possibly account forsymptoms; (3) patients with evidence of cervical radiculopa-thy, paresis, or other neurological changes in the upper limbon the involved side; (4) the presence of underlying fracture,associated inflammatory arthritis, known renal or hepaticdisease, haematopoietic disorder, malignancy, any mentaldisorder likely to interfere with the course or assessment ofthe disease process; (5) painful arc between 40∘ and 120∘abductions indicative of rotator cuff disease; (6) uncon-trolled diagnosed neurological diseases, immunodeficiency,bleeding disorders, and allergies; (7) uncontrolled medicalconditions which are unfit for acupuncture; (8) patientreceiving acupuncture currently or received acupuncture 2weeks prior to enrollment; (9) women in lactation, pregnantwomen, or with plans to get pregnant in the coming halfyear; (10) patients taking drugs such as NSAIDs or other painkillers that can affect the outcomes; (11) patients undergoingother trials.

The included patients were treated in the outpatient clin-ics of these departments. An individual researcher collectedthe data in clinics.

2.3. Interventions. Patients in acupuncture group receivedsharp-hook acupuncture plus acupoint injection with con-ventional analgesics. For control group, there was only acu-point injection with conventional analgesics. There was onlyone treatment session in both groups. All treatments wereperformed by acupuncturists with over 10 years of clinicalexperience.

2.3.1. Acupuncture Group. The procedures of sharp-hookacupuncture treatment were listed as follows.

(1) A collection of 5 acupoints, including A-Shi point,Jianyu (LI15), Jianliao (SJ14), Jianzhen (SI9), andJianqian (Ex-UE), was selected and then marked bymethylrosanilinium chloride when the patient was


in a sitting position. The locations of acupoints werereferred to in the Chinese Standard of acupoint,the GB/T 30233-2013. The local skin of the selectedacupoints was sterilized by 75% ethanol.

(2) Then, we prepared the conventional analgesics foracupoint injection to block nerve by mixing 2% lido-caine of 3mL (Zhuo Feng pharmaceutics, Zhengzhou,China), vitamin B

12of 0.5mg (Tian Jin Pharmaceu-

tics, Tianjin, China), triamcinolone acetonide acetateof 20mg (Xian Ju Pharmaceutics, Xianju, Zhejiang),and 0.9% saline of 3mL (the 4th Pharmaceuticsof Shi Jia Zhuang, Shijiazhuang, Hebei). After that,every marked acupoint was injected 1mL of the drugmixture.

(3) We then inserted the sharp-hook needle to thesubcutaneous level of these acupoints. The depth ofinsertion was depending on the depth and severity ofaffected area.

(4) The needle was kept a 45∘–75∘ angle to the surfaceof the skin and was constantly pulled in and out for3–5 times to stretch the fibers within the affectedtissue, but with the needle retained in skin. Forextreme tenses and nodules, it was necessary for theacupuncturist to intersect the fascia, muscle fibers,and ligament surrounding the rigid tissue, till thetension was removed.

(5) The needle was returned back to the angle andposition as it was inserted and then was quicklywithdrawn. After that, we applied a cup over the cut tolet the blood stasis out. At last, the cut was disinfectedand we applied a piece of BAND-AID.

To be noted, “A-Shi point” refers to the most repre-sentative point of PAS symptoms, mostly pain, on certainbody surface, where it hurts the most when pressed on withfinger(s)/treatment equipment. Therefore, no fixed locationof A-Shi point can be defined. Mostly, its identification isdepending on the location of disease, the place where theorgan was affected and where tissue was harmed.

2.3.2. Control Group. The procedures of treatment werethe same as (1) and (2) steps in acupuncture group. Theacupoints and analgesics used in control group were identicalto acupuncture group.

2.4. Outcomes. The primary outcome was the pain relief ofshoulder asmeasured byVisual Analogue Scale at 1 week aftertreatment.The secondary outcomes included (1) the functionof shoulder joint as measured by the physical examinationscore for shoulder and (2) McGill pain questionnaire. Alloutcome measurements were assessed at 0 week, 1 week, and4 weeks and were collected by an individual researcher inclinics or by telephone interview. The safety issue of sharp-hook acupuncture for patients with periarthritis of shoulderwas assessed by any related adverse events.

2.5. Sample Size. Sample size was calculated by a G∗Power3 software (Institute for Experimental Psychology, Heinrich-Heine-University, Germany). For this trial, it has been deter-minedprospectively that𝛼 = 0.05 and 1−𝛽 = 0.90. Accordingto a previous trial on acupuncture for PAS [17], a total of 120participants will be included in this trial for a compensationto 15% dropout rate, with 60 patients in each group.

2.6. Randomisation. In this trial, participants were randomlyassigned to either acupuncture group or control group ina 1 : 1 ratio. Random number sequence was computationallygenerated by clinical researcher using the SPSS 16.0 software.In the random number sequence, number “1” representsacupuncture group, while number “2” stands for the controlgroup. Each random number was carefully concealed bythe clinical researcher in an sequentially numbered opaqueenvelope which was not permitted for acupuncturist tounfold until eligible patients were included in this trial withwritten informed consent. After a patient was enrolled inthe trial by the clinical trial communicator, the clinicianwould open one of the opaque envelopes according to his/herinclusion order and then further assign the patient to eitheracupuncture or control group.

2.7. Blinding. As an open-labeled clinical trial, the patientsand clinicians would not be blinded in the whole treat-ment process. Patients in each group knew which treatmentapproach they would receive; they were required to cooperatewith their physicians or therapists prior to treatment. Theassessment of clinical effectiveness was performed throughtelephone interview by a clinical assessor who was maskedto the treatment assignment. While in data collection andanalysis stage, the clinical researcher, assessor, and statisticianwere, respectively, separated from each other.

2.8. Statistical Methods. All main analyses (with SPSS 16.0)were based on the intention-to-treat population which auto-matically imputed the missing data according to the last visitdata. Additionally, a per protocol analysis was done includingonly patients with no major protocol violations by the endof 4 weeks after randomization. The demographic, clinical,and outcome variables at baseline were described by usingmeans and standard deviations for continuous variables.Two-sample 𝑡-test analysis of variance was used to comparebaseline data and difference between groups. Paired 𝑡-testanalyses were used to compare the pre- and posttreatmentdata within group. A two tailed 𝑃 < 0.05 was consideredsignificantly different.

3. Results

156 patients were enrolled in this study, but only 132 eligi-ble ones were included to received treatment. 24 patientswere excluded due to various reasons. For the includedpatients, 120 completed the trial (see Figure 2). Six patients inacupuncture group discontinued the study due to unsatisfac-tion, traffic problem; 6 patients in control group abandonedthe treatment due to reasons that are unclear. Due to the very


Excluded from analysis (reason unclear)

(ii) Did not receive allocated intervention

Allocation

Analysis

Follow-up

Enrollment

(iii) Other reasons (n = 3)(ii) Declined to participate (n = 3)(i) Not meeting inclusion criteria (n = 18)

Excluded (n = 24)

Assessed for eligibility (n = 156)

Allocated to acupuncture (n = 66)

Analysed (n = 59)Excluded from analysis (taking ibuprofen)

Analysed (n = 58)

(i) Received allocated intervention (n = 60)

(unsatisfied, traffic problem) (n = 6)(ii) Did not receive allocated intervention

Allocated to acupuncture (n = 66)

Randomized (n = 132)

(i) Received allocated intervention (n = 60)

(reasons unclear) (n = 6)

Lost to follow-up (give reasons) (n = 0) Lost to follow-up (give reasons) (n = 0)

(n = 1) (n = 2)

Figure 2: Trial flow chart.

short follow-up period, all patients returned follow-up data.In data analysis, 59 patients in acupuncture group and 58patients in control group were included in ITT analysis.

3.1. Baseline Data. The demographic information and base-line comparison between groups were shown in Table 1.There was no significant difference in age, gender, anddisease history between groups (𝑃 > 0.05). Moreover, thepain intensity no matter measured by VAS or McGill painquestionnaire and the shoulder joint function scoremeasuredby general physical examination were not significant betweenacupuncture group and control group (𝑃 > 0.05).

3.2. Outcomes and Estimation. The pain intensity and jointfunction score at 1 week and 4 weeks after randomizationwere listed in Table 2. The result showed that both acupunc-ture and conventional analgesics significantly reduced painintensity of PAS measured by VAS as compared with theirrespective baseline condition (𝑃 < 0.05). The comparisonbetween two groups showed that, at 1 week after random-ization, the pain intensity measured by VAS in acupunc-ture groups showed more significant reduction than controlgroup (𝑃 < 0.0001). Pain intensity measured by McGillpain questionnaire showed similar significant reduction inboth groups (𝑃 < 0.05). At 1 week after randomization,acupuncture significantly reduced pain intensity measuredby McGill pain questionnaire compared with control group

Table 1: Baseline information of two groups (mean ± SD).

Acupuncturegroup

Controlgroup 𝑃 value

Age (years) 51.2 ± 7.1 49.6 ± 9.7 0.3102Gender (male/female) 26/33 28/30 0.6517Disease history(month) 15.2 ± 8.3 14.9 ± 9.5 0.8559

Pain intensitymeasured by VAS 7.32 ± 1.51 7.51 ± 1.43 0.4862

McGill painquestionnaire 31.52 ± 4.53 32.21 ± 4.15 0.3923

Shoulder jointfunction score 102.42 ± 4.88 100.68 ± 5.52 0.0733

(𝑃 < 0.01). Moreover, the function of shoulder joint wassignificantly improvement in both groups as compared withbaseline (𝑃 < 0.05). The comparison between acupuncturegroup and control group showed that shoulder joint functionwas significantly improvement in sharp-hook acupuncturegroup as compared with control group at 1 week afterrandomization.

However, in the 4-week follow-up, the pain intensity andshoulder joint function of patients in control group relapsedbut still with statistical difference as compared with baseline.As to acupuncture group, the pain intensity and shoulderjoint function were significantly improved as compared with


Table 2: Pain relief and shoulder joint function recovery at 1 week and 4 weeks after randomization.

Acupuncture group Control group 𝑃 value1 week after randomization

Pain intensity measured by VAS 1.25 ± 0.36 3.695 ± 1.16


Baseline 1 week 4 weeks

0

5

10

AcupunctureControl

Vas s

core

(a)

AcupunctureControl

McG

ill p

ain

scor

e

Baseline 1 week 4 weeks0

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40

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AcupunctureControl

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Figure 3: Changes in pain intensity and shoulder joint function in trial process and follow-ups.

pathological deformations in the local area of the affectedshoulder of PAS patient [26, 27].These pathological manifes-tations include capsulitis of the shoulder, trigger point [28]or pressing pain point, tensions, rigid muscle, or even nodes.In traditional Chinese medicine, this pathological presencewas regarded as a convergence of unsmooth Qi and blood,blood stasis, and hot or cold phlegm. These pathologicalfactors blocked the meridians and channels to cause pain andlimited joint function. In modern medicine, the treatmentemphasizes mostly emphasized local nerve block to stop painwith ignorance of the pathological presences, which maycontribute to the relapse of pain and function limitation asobserved in control group. While this trial applied threeacupoints of the three Yang meridians of hand (namely, threeacupoints for shoulders), accompanied with an extra-pointJianqian and the local A-Shi point to dredge the meridian,activate Qi and blood to remove pain. Moreover, the sharp-hook acupuncture needle is very unique in shape whichenables it to be very convenient to remove or intersect thesoft tissue adherence. In clinical practice, the sharp-hookacupuncture needle was used to deprive the functional soft

tissue from adhering tissue, then to dissect the pathologicalscarwithin the affect joint and intersect the connections of thepathological nodes, according to blunt dissection and sharpdissection.The location of soft tissue and function of shoulderjoint were restored by this procedure [29]. It is speculated thatthe dissection of these pathological presences by sharp-hookacupuncture needles is essential to the sustainable effect ofsharp-hook acupuncture observed in the acupuncture groupas compared with control group.

Safety is a very important issue for no matter noveltherapy or traditional treatments. Actually, we have assessedthe safety of sharp-hook needle. It is assessed by the adverseevents reported by patients and doctors. We have a specificsection in our case report form called “adverse events,” inwhich any adverse events including bleeding, hematoma,dizziness, faint, and nausea would be recorded if developed.This helps us to address the safety issue. However, there isno adverse events reported in our patients. It is true thatthe three-edge hook is thick and long in some cases. But thefact is that all our treatments were performed on the basisof local anesthesia by acupoint injection of 2% lidocaine.


In addition, all practitioners are very experienced clinicaldoctors. Their clinical skills and communication ability arecritical in this study. These are the reasons why the patientssafety was guaranteed and their rights were respected. Thus,the sharp-hook needle is safe for PAS patients when handledwith appropriateness.

Besides, the sharp-hook acupuncture needle invented byour team can also be used to perform blood-letting therapyby

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