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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Influences of De Qi induced by acupuncture on immediate and accumulated analgesic effects in patients with knee osteoarthritis: study protocol for a randomized controlled trial

Authors: Min Li, Hongwen Yuan, Pei Wang, Siyuan Xin, Jie Hao, Miaomiao Liu, Jinfeng Li, Man Yu, Xinrui Zhang

Published in: Trials | Issue 1/2017

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Abstract

Background

De Qi is a special sensational response upon acupuncture needling. According to traditional acupuncture theory, the treatment is “effective only after Qi arrival”; that is, De Qi is an important indicator of therapeutic efficacy and good prognosis. However, it is still disputable whether De Qi improves the efficacy of acupuncture therapy. This prospective, randomized controlled trial aims to explore the influence of De Qi induced by acupuncture on immediate and accumulated analgesic effects in patients with knee osteoarthritis (KOA).

Methods/design

Eighty-eight patients with KOA will be recruited and randomly assigned to the De Qi group (enhanced stimulation to evoke De Qi) and the control group (weak stimulation to avoid De Qi) in the Department of Acupuncture and Physical Therapy, Beijing Luhe Hospital Affiliated to Capital Medical University. Each patient will receive three 30-minute sessions per week for 4 consecutive weeks and undergo a 1 month follow-up. The severity of knee pain, as measured on a 100-mm visual analog scale (where 0 indicates no pain and 100 indicates intolerable pain) will be used as the primary outcome, and the Knee injury and Osteoarthritis Outcome Score will be used as the secondary outcome. Both indexes will be measured before and after the 1st (for evaluating the immediate analgesic effects), 3rd, 6th, 9th, and 12th (for evaluating the accumulated analgesic effects) treatments and at the end of the follow-up. The intensity of the De Qi sensation will be assessed by the Chinese-Modified Massachusetts General Hospital Acupuncture Sensation Scale at the end of each treatment. Side effects during the treatments will be recorded and analyzed as well. The comparisons between the De Qi group and the control group will be done by using both an intention-to-treat analysis and a per-protocol analysis.

Discussion

This prospective randomized controlled study will be helpful in enhancing our understanding of the analgesic effect of De Qi on patients with KOA and may provide a clinical basis for further investigation of the relationship between De Qi and the therapeutic efficacy of acupuncture, thereby offering some evidence for the role of De Qi in an efficacious acupuncture therapy.

Trial registration

Chinese Clinical Trial Registry, ChiCTR-IIR-16008972. Registered on 4 August 2016 Additional file 2.
Appendix
Available only for authorised users
Literature
1.
Xuemin S, Lingling W. Science of acupuncture and moxibustion. 2nd ed. Beijing: China Traditional Chinese Medicine Publishing House; 2010. p. 147.
2.
Vas J, Perea-Milla E, Méndez C, Sánchez Navarro C, León Rubio JM, Brioso M, et al. Efficacy and safety of acupuncture for chronic uncomplicated neck pain: a randomized controlled study. Pain. 2006;126(1-3):245–55.CrossRefPubMed
3.
Witt C, Brinkhaus B, Jena S, Linde K, Streng A, Wagenpfeil S, et al. Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet. 2005;366:136–43.CrossRefPubMed
4.
Takeda W, Wessel J. Acupuncture for the treatment of pain of osteoarthritic knees. Arthritis Care Res. 1994;7(3):118–22.CrossRefPubMed
5.
6.
Shi GX, Li QQ, Liu CZ1, Zhu J, Wang LP, Wang J, Han LL, et al. Effect of acupuncture on Deqi traits and pain intensity in primary dysmenorrhea: analysis of data from a larger randomized controlled trial. BMC Complement Altern Med. 2014. doi: 10.​1186/​1472-6882-14-69.
7.
Kong J, Fufa DT, Gerber AJ, Rosman IS, Vangel MG, Gracely RH, et al. Psychophysical outcomes from a randomized pilot study of manual, electro, and sham acupuncture treatment on experimentally induced thermal pain. J Pain. 2005;6(1):55–64.CrossRefPubMed
8.
Haake M, Müller HH, Schade-Brittinger C, Basler HD, Schäfer H, Maier C, et al. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med. 2007;167(17):1892–8.CrossRefPubMed
9.
Scharf HP, Mansmann U, Streitberger K, Witte S, Krämer J, Maier C, et al. Acupuncture and knee osteoarthritis: a three-armed randomized trial. Ann Intern Med. 2006;145(1):12–20.CrossRefPubMed
10.
Lund I, Lundeberg T, Lönnberg L, Svensson E. Decrease of pregnant women's pelvic pain after acupuncture: a randomized controlled single-blind study. Acta Obstet Gynecol Scand. 2006;85(1):12–9.
11.
Chen Q, Zhang Q, Jiang L, Li X, Liu Y, Xie Y, et al. Effectiveness of strengthened stimulation during acupuncture for the treatment of allergic rhinitis: study protocol for a randomized controlled trial. Trials. 2014. doi:10.​1186/​1745-6215-15-301.
12.
Xie H, Li X, Lai J, Zhou Y, Wang C, Liang J. Effectiveness of De Qi during acupuncture for the treatment of tinnitus: Study protocol for a randomized controlled trial. Trials. 2014. doi:10.​1186/​1745-6215-15-397.
13.
Yanhong C, Xiaobing S. Current status and progress on the epidemiology of knee osteoarthritis at home and abroad. Chin J Tradit Med Traumatol Orthop. 2012;06:81–4.
14.
Haozhu C, Zongming L. Internal medicine. 2nd ed. Beijing: People’s Medical Publishing House; 1999. p. 833.
15.
Wang Q, Huang C. Advances in diagnosis and treatment of osteoarthritis. Clin Med J. 2010;8:36–47.
16.
Jianhua Y, Yushan F, Xiao H. Treatment by needling at positive reaction point of 30 cases on knee arthritis. J External Ther Tradit Chin Med. 2011;20(3):36.
17.
Kang L, Lifang L. Knee osteoarthritis treated with acupuncture at Neiguan (PC6) and Taichong (LR 3). Chin Acupunct Moxibustion. 2013;33(2):105–8.
18.
Zhong D, Qiang L, Wen B, Hongshegn L, Jiayi Y, Shaojie W. Efficacy observation of knee osteoarthritis treated with acupuncture. Chin Acupunct Moxibustion. 2012;32(9):785–8.
19.
Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986;29(8):1039–49.CrossRefPubMed
20.
Jialiang W. Clinical epidemiology. 3rd ed. Shanghai: Shanghai Science and Technology Publishing House; 2009. p. 178.
21.
Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9(2):105–21.CrossRefPubMed
22.
White P, Prescott P, Lewith G. Does needling sensation (De Qi) affect treatment outcome in pain? Analysis of data from a larger single-blind, randomized controlled trial. Acupunct Med. 2010;28(3):120–5.CrossRefPubMed
23.
Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003;1:64.CrossRefPubMedPubMedCentral
24.
Xiong J, Liu F, Wang W, Huang G. The effects of Deqi and manual acupuncture needle manipulation on the clinical outcomes of acupuncture analgesia. Liaoning J Tradit Chin Med. 2011;38(8):1482–5.
25.
Xu SB, Huang B, Zhang CY, Du P, Yuan Q, Bi GJ, et al. Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial. CMAJ. 2013;185(6):473–9.CrossRefPubMedPubMedCentral
26.
Choi YJ, Lee JE, Moon WK, Cho SH. Does the effect of acupuncture depend on needling sensation and manipulation? Complement Ther Med. 2013;21(3):207–14.CrossRefPubMed
27.
Benham A, Johnson MI. Effect of bidirectional rotation of an acupuncture needle at LI10 on acupuncture needle sensation and experimentally-induced contact heat pain in healthy human volunteers. Acupunct Med. 2014;32(3):267–72.CrossRefPubMed
28.
Li G, Yang ES. An fMRI study of acupuncture-induced brain activation of aphasia stroke patients. Complement Ther Med. 2011;19 Suppl 1:S49–59.CrossRefPubMed
29.
Huang Y, Jiang X, Zhuo Y, Tang A, Wik G. Complementary acupuncture treatment increases cerebral metabolism in patients with Parkinson’s disease. Int J Neurosci. 2009;119(8):1190–7.CrossRefPubMed
30.
Hui KK, Nixon EE, Vangel MG, Jing L, Marina O, Napadow V, et al. Characterization of the “De Qi” response in acupuncture. BMC Complement Altern Med. 2007;7:33.CrossRefPubMedPubMedCentral
31.
Asghar AU, Green G, Lythgoe MF, et al. Acupuncture needling sensation: the neural correlates of deqi using fMRI. Brain Res. 2010;1315(8):111–8.CrossRefPubMed
32.
Hui KK, Marina O, Claunch JD, Nixon EE, Fang J, Liu J, et al. Acupuncture mobilizes the brain’s default mode and its anti-correlated network in healthy subjects. Brain Res. 2009;1287:84–103.CrossRefPubMedPubMedCentral
33.
Bai L, Qin W, Tian J, Dong M, Pan X, Chen P, et al. Acupuncture modulates spontaneous activities in the anticorrelated resting brain networks. Brain Res. 2009;1279:37–49.CrossRefPubMed
34.
Wu MT, Hsieh JC, Xiong J, Yang CF, Pan HB, Chen YC, et al. Central nervous pathway for acupuncture stimulation: localization of processing with functional MR imaging of the brain-preliminary experience. Radiology. 1999;212(1):133–41.CrossRefPubMed
35.
Wei Q, Tian J, Pan X, Yang L, Zhen Z, et al. The correlated network of acupuncture effect: a functional connectivity study. Conf Proc IEEE Eng Med Biol Soc. 2006;1:480–3.
Metadata
Title
Influences of De Qi induced by acupuncture on immediate and accumulated analgesic effects in patients with knee osteoarthritis: study protocol for a randomized controlled trial
Authors
Min Li
Hongwen Yuan
Pei Wang
Siyuan Xin
Jie Hao
Miaomiao Liu
Jinfeng Li
Man Yu
Xinrui Zhang
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1975-7

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