Search JIM Advanced Search

Journal of Integrative Medicine ›› 2016, Vol. 14 ›› Issue (3): 219-227.doi: 10.1016/S2095-4964(16)60254-6

Special Issue: Acupuncture & Moxibustion

• Study Protocol • Previous Articles     Next Articles

Evaluation of the effect of acupuncture on hand pain, functional deficits and health-related quality of life in patients with rheumatoid arthritis—A study protocol for a multicenter, double-blind, randomized clinical trial

SusanaSecaa,b,c, SebastianKirchb,c, António S.Cabritaa, Henry J.Gretenb,c   

  1. a Faculty of Medicine, University of Coimbra, 3045-137 Coimbra, Portugal 
    b Institute of Biomedical Sciences Abel Salazar, University of Porto, 4050-313 Porto, Portugal 
    c Heidelberg School of Chinese Medicine, 69126 Heidelberg, Germany
  • Received:2015-12-10 Accepted:2016-01-19 Online:2016-05-15 Published:2016-05-15
  • Contact: Susana Seca, MSc; E-mail: susana.seca@hotmail.com

Background

Rheumatoid arthritis (RA) is a systemic inflammatory disease characterized by functional disability and pain. Although acupuncture is widely used, until now Western acupuncture studies on RA have not shown conclusive positive results. Acupuncture is regarded as a reflex therapy that has effects on the human autonomic nervous system. By establishing a traditional Chinese medicine (TCM) diagnosis first, the practitioner is able to choose acupoints according to the state of each individual patient.

Methods/Design

We are interested if acupuncture, using a classical diagnostic procedure to allocate acupoints to the patient according to the Shang Han Lun theory, can be effective in relieving pain, improving hand function and increasing health-related quality of life in RA. The authors intend to harmonize TCM diagnosis according to clinical and genetic profiles. Patients with the TCM diagnosis of a so-called Turning Point syndrome will be followed up in a randomized, prospective, double-blind, placebo-controlled, multicenter and three-armed parallel-group study with a standardized treatment in order to optimize potential therapeutic effects of acupuncture on pain, strength and muscle function of patients with RA as well as the influence on inflammation and quality of life.

Discussion

The findings of this study will provide important clinical information about the feasibility and efficacy of acupuncture treatment for RA patients. In addition, it will explore the feasibility of further acupuncture research.

Trial Registration Number

ClinicalTrials.gov Identifier NCT02553005.

Key words: Acupuncture, Rheumatoid arthritis, Quality of life, Pain, Hand strength, Study protocol, Randomized clinical trial, Double-blind method

1 Carrilho F. Influência da vitamina D na actividade da artrite reumatóide. Tese de Mestrado, apresentada à Faculdade de Medicina de Coimbra. Coimbra, 2009. French.
2 Horsten NC, Ursum J, Roorda LD, van Schaardenburg D, Dekker J, Hoeksma AF. Prevalence of hand symptoms, impairments and activity limitations in rheumatoid arthritis in relation to disease duration. [J] Rehabil Med. 2010; 42(10): 916-921.
3 Richmond SJ.Magnet therapy for the relief of pain and inflammation in rheumatoid arthritis (CAMBRA): a randomised placebo-controlled crossover trial. Trials. 2008; 9: 53.
4 Wang C, de Pablo P, Chen X, Schmid C, McAlindon T. Acupuncture for pain relief in patients with rheumatoid arthritis: a systematic review. Arthritis Rheum. 2008; 59(9):
5 1249-1256.
5 Wang J, Cui M, Jiao H, Tong Y, Xu J, Zhao Y, Han M, Liu J.Content analysis of systematic reviews on effectiveness of traditional Chinese medicine. [J] Tradit Chin Med. 2013; 33(2): 156-163.
6 Lee MS, Shin BC, Ernst E.Acupuncture for rheumatoid arthritis: a systematic review. Rheumatology (Oxford). 2008; 47(12): 1747-1753.
7 Macfarlane GJ, Paudyal P, Doherty M, Ernst E, Lewith G, MacPherson H, Sim J, Jones GT; Arthritis Research UK Working Group on Complementary and Alternative Therapies for the Management of the Rheumatic Diseases. A systematic review of evidence for the effectiveness of practitioner-based complementary and alternative therapies in the management of rheumatic diseases: rheumatoid arthritis. Rheumatology (Oxford). 2012; 51(9): 1707-1713.
8 Tam LS, Leung PC, Li TK, Zhang L, Li EK.Acupuncture in the treatment of rheumatoid arthritis: a double-blind controlled pilot study. BMC Complement Alternat Med. 2007; 7: 35.
9 Zanette Sde A, Born IG, Brenol JC, Xavier RM.A pilot study of acupuncture as adjunctive treatment of rheumatoid arthritis. Clin Rheumatol. 2008; 27(5): 627-635.
10 Hui KK, Marina O, Liu J, Rosen BR, Kwong KK.Acupuncture, the limbic system, and the anticorrelated networks of the brain. Auton Neurosci. 2010; 157(1-2): 81-90.
11 Lee WY, Chen HY, Chen KC, Chen CY.Treatment of rheumatoid arthritis with traditional Chinese medicine. Biomed Res Int. 2014; 2014: 528018.
12 He TF, Yang WJ, Zhang SH, Zhang CY, Li LB, Chen YF.Electroacupuncture inhibits inflammation reaction by upregulating vasoactive intestinal peptide in rats with adjuvant-induced arthritis. Evid Based Complement Alternat Med. 2011; 2011: 290489.
13 Zhao C, Li GZ, Wang C, Niu J.Advances in patient classification for traditional Chinese medicine: a machine learning perspective. Evid Based Complement Alternat Med. 2015; 2015: 376716.
14 van Wietmarschen HA, Dai W, van der Kooij AJ, Reijmers TH, Schroën Y, Wang M, Xu Z, Wang X, Kong H, Xu G, Hankemeier T, Meulman JJ, van der Greef J. Characterization of rheumatoid arthritis subtypes using symptom profiles, clinical chemistry and metabolomics measurements. PLoS One. 2012; 7(9): e44331.
15 Zhang C, Jiang M, Lü AP.Evidence-based Chinese medicine for rheumatoid arthritis. [J] Tradit Chin Med. 2011: 31(2): 152-157.
16 Lu C, Niu X, Xiao C, Chen G, Zha Q, Guo H, Jiang M, Lu A.Network-based gene expression biomarkers for cold and heat patterns of rheumatoid arthritis in traditional Chinese medicine. Evid Based Complement Alternat Med. 2012; 2012: 203043.
17 Wang M, Chen G, Lu C, Xiao C, Li L, Niu X, He X, Jiang M, Lu A.Rheumatoid arthritis with deficiency pattern in traditional Chinese medicine shows correlation with cold and hot patterns in gene expression profiles. Evid Based Complement Alternat Med. 2013; 2013: 248650.
18 van der Greef J, van Wietmarschen H, Schroën J, Wang M, Hankemeier T, Xu G. Systems biology-based diagnostic principles as pillars of the bridge between Chinese and Western medicine. Planta Med. 2010; 76(17): 2036-2047.
19 Porkert M. Chinese medical diagnostics. Health Harmony-B. Jain.2001. Germany.
20 Zhong L, Hong H.Dr. Chen Xiangjun’s experience in using pair of drugs to treat rheumatic diseases. [J] Tradit Chin Med. 2005; 25(4): 282-289.
21 Greten HJ.Understanding TCM—scientific Chinese medicine. Heidelberg School, Heidelberg, Germany. 2013.
22 Greten HJ. Kursbuch traditionelle chinesische Medizin: TCM verstehen und richtig anwenden. Stuttgart: Georg Thieme Verlag.2007. German.
23 Karner M, Brazkiewicz F, Remppis A, Fischer J, Gerlach O, Stremmel W, Subramanian SV, Greten HJ.Objectifying specific and nonspecific effects of acupuncture: a double-blinded randomised trial in osteoarthritis of the knee. Evid Based Complement Alternat Med. 2013; 2013: 427265.
24 Seca S, Capelo P, Efferth T, Doenitz CA, Schroeder S, Anjos A, Machado J, Greten HJ.Diagnosis and objective pain assessment of traditional Chinese medicine may be useful to demonstrate specific effects of acupuncture in low back pain: A prospective, randomized, controlled and single blinded pre-study. [J] Acupunct Tuina Sci. 2013; 11(3): 155-159.
25 Chen PD, Chen GZ, Xu YX.Study strategies for bloodletting therapy in treatment of acute soft tissue injuries. [J] Chin Integr Med. 2011; 9(3): 237-241.
26 Anderson J, Caplan L, Yazdany J, Robbins ML, Neogi T, Michaud K, Saag KG, O’Dell JR, Kazi S. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis Care Res (Hoboken). 2012; 64(5): 640-647.
27 Kinser AM, Sands WA, Stone MH.Reliability and validity of a pressure algometer. [J] Strength Cond Res. 2009; 23(1): 312-314.
28 Lo LC, Cheng TL, Chiang JY, Damdinsuren N.Brest cancer index: a perspective on tongue diagnosis in traditional Chinese medicine. [J] Tradit Complement Med. 2013; 3(3): 194-203.
29 Soeken KL, Miller SA, Ernst E.Herbal medicines for the treatment of rheumatoid arthritis: a systematic review. Rheumatology (Oxford). 2003; 42(5): 652-659.
30 Greten HJ.What is the role of Chinese medical theory in modern scientific research. [J] Acupunct Tuina Sci. 2008; 6(5): 259-260.
31 Zhang F, Xie JM, Zhang YY, Kong LL, Li SC.What is important during the selection of traditional Chinese medicine (TCM) in a health care reimbursement or insurance system? Critical issues of assessment from the perspective of TCM practitioners. Value Health Reg Issues. 2013; (2): 141-146.
32 He Y, Lu A, Zha Y, Yan X, Song Y, Zeng S, Liu W, Zhu W, Su L, Feng X, Qian X, Lu C.Correlations between symptoms as assessed in traditional Chinese medicine (TCM) and ACR20 efficacy response: a comparison study in 396 patients with rheumatoid arthritis treated with TCM or Western medicine. J Clin Rheumatol. 2007; 13(6): 317-321.
33 Ross J.Acupunture point combinations: the key to clinical success. Churchill Livingstone. 1995.
[1] Chiung-Hui Huang, Mei-Ling Yeh, Fang-Pey Chen, Daphne Wu. Low-level laser acupuncture reduces postoperative pain and morphine consumption in older patients with total knee arthroplasty: A randomized placebo-controlled trial. Journal of Integrative Medicine, 2022, 20(4): 321-328.
[2] Ming-min Xu, Pei Guo, Qing-yu Ma, Xuan Zhou, Yu-long Wei, Lu Wang, Yue Chen, Yu Guo. Can acupuncture enhance therapeutic effectiveness of antidepressants and reduce adverse drug reactions in patients with depression? A systematic review and meta-analysis. Journal of Integrative Medicine, 2022, 20(4): 305-320.
[3] Yen-Lin Chao, Yi-Ai Rau, Hong-Sheng Shiue, Jiun-Lin Yan, Yuan-Yun Tang, Shao-Wen Yu, Bo-Yan Yeh, Yen-Lung Chen, Tsung-Hsien Yang, Shu-Chen Cheng, Yi-Wen Hsieh, Hsin-Chia Huang, Fu-Kuang Tsai, Yu-Sheng Chen, Geng-Hao Liu. Using a consensus acupoints regimen to explore the relationship between acupuncture sensation and lumbar spinal postoperative analgesia: A retrospective analysis of prospective clinical cooperation. Journal of Integrative Medicine, 2022, 20(4): 329-337.
[4] Sergey Filist, Riad Taha Al-Kasasbeh, Olga Shatalova, Nikolay Korenevskiy, Ashraf Shaqadan, Zeinab Protasova, Maksim Ilyash, Mikhail Lukashov. Biotechnical system based on fuzzy logic prediction for surgical risk classification using analysis of current-voltage characteristics of acupuncture points. Journal of Integrative Medicine, 2022, 20(3): 252-264.
[5] Ting-ting Lu, Cun-cun Lu, Mei-xuan Li, Li-xin Ke, Hui Cai, Ke-hu Yang. Reporting and methodological quality of meta-analyses of acupuncture for patients with migraine: A methodological investigation with evidence map. Journal of Integrative Medicine, 2022, 20(3): 213-220.
[6] Xiang-yu Wei, Shi-lei Luo, HuiChen, Shan-shan Liu, Zhi-gang Gong, Song-huaZhan. Functional connectivity changes during migraine treatment with electroacupuncture at Shuaigu (GB8). Journal of Integrative Medicine, 2022, 20(3): 237-243.
[7] Samwel Sylvester Msigwa, Yan Li, Xiang-lin Cheng, Fen Cao. Combining electroacupuncture and transcranial direct current stimulation as an adjuvant therapy enhances spontaneous conversation and naming in subacute vascular aphasia: A retrospective analysis. Journal of Integrative Medicine, 2022, 20(3): 244-251.
[8] Xin Wang, Wen-juan Song, Yi Ruan, Bing-chu Li, Can Lü, Nian Huang, Fan-fu Fang, Wei Gu. Core muscle functional strength training for reducing the risk of low-back pain in military recruits: An open-label randomized controlled trial. Journal of Integrative Medicine, 2022, 20(2): 145-152.
[9] Xiao Ye, Yu-lan Ren, Yun-hui Chen, Ji Chen, Xiao-jiao Tang, Zong-ming Zhang. A "4D" systemic view on meridian essence: Substantial, functional, chronological and cultural attributes. Journal of Integrative Medicine, 2022, 20(2): 96-103.
[10] Bin Zhao, Yong Chen, Shi-min Liao, Jian-ying Zheng, Shi-hua Yan, Dong-shu Zhang. Successfully treated recalcitrant atopic eczema with acupoint autohemotherapy: A case report and hypothesized mechanism of the therapy. Journal of Integrative Medicine, 2022, 20(2): 182-186.
[11] Jun-peng Yao, Li-ping Chen, Xian-jun Xiao, Ting-hui Hou, Si-yuan Zhou, Ming-min Xu, Kai Wang, Yu-jun Hou, Lin Zhang, Ying Li. Effectiveness and safety of acupuncture for treating functional constipation: An overview of systematic reviews. Journal of Integrative Medicine, 2022, 20(1): 13-25.
[12] Xin Yin, Shu-bin Cai, Lan-ting Tao, Lu-ming Chen, Zhong-de Zhang, Su-hong Xiao, Arthur Yin Fan, Xu Zou. Recovery of a patient with severe COVID-19 by acupuncture and Chinese herbal medicine adjuvant to standard care. Journal of Integrative Medicine, 2021, 19(5): 460-466.
[13] Thomas Efferth, An-long Xu, Roxana Damiescu, Mita Banerjee, Norbert W. Paul, David Y.W. Lee. Can eastern wisdom resolve western epidemics? Traditional chinese medicine therapies and the opioid crisis. Journal of Integrative Medicine, 2021, 19(4): 295-299.
[14] Zahra Karimzadeh, Mansooreh Azizzadeh Forouzi, Haleh Tajadini, Mehdi Ahmadinejad, Callista Roy, Mahlagha Dehghan. Effects of lavender and Citrus aurantium on pain of conscious intensive care unit patients: A parallel randomized placebo-controlled trial. Journal of Integrative Medicine, 2021, 19(4): 333-339.
[15] Ju-Yeon Park, Young-Won Kwon, Sun-Ah Kim, Sun-Dong Park, Chang-Hyun Kim, Jin-Hee Kim, Ju-Hee Lee. Polyherbal formula SC-E3 inhibits rheumatoid arthritis activity in a mouse model of type-II collagen-induced arthritis. Journal of Integrative Medicine, 2021, 19(3): 265-273.
Viewed
Full text


Abstract

Cited

  Shared   
  Discussed   
[1] Jin-rong Fu. Establishment of multivariate diagnosis and treatment system of modern gynecology of traditional Chinese medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 22-24
[2] Hao Li, Ming-jiang Yao, Wen-ming Zhao, Jie Guan, Lin-lin Cai, Ling Cui. A randomized, controlled, double-blind trial of Huannao Yicong capsule in senile patients with mild cognitive impairment. Journal of Chinese Integrative Medicine, 2008, 6(1): 25-31
[3] Zhi-chun Jin. Problems in establishing clinical guideline for integrated traditional Chinese and Western medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 5-8
[4] SUN Ming-yu, ZUO Jian, DUAN Ji-feng, HAN Jun, FAN Shi-ming, ZHANG Wei, ZHU Li-fang, YAO Ming-hui. Antitumor activities of kushen flavonoids in vivo and in vitro. Journal of Chinese Integrative Medicine, 2008, 6(1): 51-59
[5] Min Cheng, Qiong Feng, Shu-wen Qian, Hui Gao, Cui-qing Zhu. Preliminary assay of p-amyloid binding elements in heart-beneficial recipe. Journal of Chinese Integrative Medicine, 2008, 6(1): 68-72
[6] Ning-qun Wang, Liang-duo Jiang, Zong-xing Li. Research progress in asthma-related quality of life. Journal of Chinese Integrative Medicine, 2008, 6(1): 93-97
[7] Jing-yuan Mao, Chang-xiao Liu, Heng-he Wang, Guang-li Wei , Zhen-peng Zhang, Jie Xing, Wang Xian liang , Ying-fei Bi . Effects of Shenmai Injection on serum concentration and pharmacokinetics of digoxin in dogs with heart failure. Journal of Chinese Integrative Medicine, 2010, 8(11): 1070-1074
[8] Zhi-mei Wang, Bin Zhang. A study on translation of ellipses in Huangdi Neijing from perspective of hermeneutic theory. Journal of Chinese Integrative Medicine, 2010, 8(11): 1097-1100
[9] Gui Yu, Jie Wang. Thinking on building the network cardiovasology of Chinese medicine. Journal of Chinese Integrative Medicine, 2012, 10(11): 1206-1210
[10] Pedro Saganha João, Doenitz Christoph, Greten Tobias, Efferth Thomas, J. Greten Henry. Qigong therapy for physiotherapists suffering from burnout: a preliminary study. Journal of Chinese Integrative Medicine, 2012, 10(11): 1233-1239