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Open Access 01-12-2022 | Acupuncture | Study protocol

Cerebral mechanism of opposing needling for managing acute pain after unilateral total knee arthroplasty: study protocol for a randomized, sham-controlled clinical trial

Authors: Chi Zhao, Hui Xu, Xinyu A, Bingxin Kang, Jun Xie, Jun Shen, Songtao Sun, Sheng Zhong, Chenxin Gao, Xirui Xu, Youlong Zhou, Lianbo Xiao

Published in: Trials | Issue 1/2022

Abstract

Background

Opposing needling is a unique method used in acupuncture therapy to relieve pain, acting on the side contralateral to the pain. Although opposing needling has been used to treat pain in various diseases, it is not clear how opposing needling affects the activity of the central nervous system to relieve acute pain. We herein present the protocol for a randomized sham-controlled clinical trial aiming to explore the cerebral mechanism of opposing needling for managing acute pain after unilateral total knee arthroplasty (TKA).

Methods

This is a randomized sham-controlled single-blind clinical trial. Patients will be allocated randomly to two parallel groups (A: opposing electroacupuncture group; B: sham opposing electroacupuncture group). The Yinlingquan (SP9), Yanglingquan (GB34), Futu (ST32), and Zusanli (ST36) acupoints will be used as the opposing needling sites in both groups. In group A, the healthy lower limbs will receive electroacupuncture, while in group B, the healthy lower limbs will receive sham electroacupuncture. At 72 h after unilateral TKA, patients in both groups will begin treatment once per day for 3 days. Functional magnetic resonance imaging will be performed on all patients before the intervention, after unilateral TKA, and at the end of the intervention to detect changes in brain activity. Changes in pressure pain thresholds will be used as the main outcome for the improvement of knee joint pain. Secondary outcome indicators will include the visual analogue scale (including pain during rest and activity) and a 4-m walking test. Surface electromyography, additional analgesia use, the self-rating anxiety scale, and the self-rating depression scale will be used as additional outcome indices.

Discussion

The results will reveal the influence of opposing needling on cerebral activity in patients with acute pain after unilateral TKA and the possible relationship between cerebral activity changes and improvement of clinical variables, which may indicate the central mechanism of opposing needling in managing acute pain after unilateral TKA.

Trial registration

Study on the brain central mechanism of opposing needling analgesia after total kneearthroplasty based on multimodal MRI ChiCTR2100042429. Registered on January 21, 2021

Available only for authorised users

Jüni P, Reichenbach S, Dieppe P. Osteoarthritis: rational approach to treating the individual. Best Pract Res Clin Rheumatol. 2006;20(40):721–40. https://doi.org/10.1016/j.berh.2006.05.002.CrossRefPubMed

Schwartz AM, Farley KX, Guild GN, et al. Projections and epidemiology of revision hip and knee arthroplasty in the United States to 2030. J Arthroplasty. 2020;06(35):S79–85. https://doi.org/10.1016/j.arth.2020.02.030.CrossRef

Van der Woude JA, Nair SC, Custers RJ, et al. Knee joint distraction compared to total knee arthroplasty for treatment of end stage osteoarthritis: simulating long-term outcomes and cost-effectiveness. PLoS ONE. 2016;11(5):e0155524. https://doi.org/10.1371/journal.pone.0155524.CrossRefPubMedPubMedCentral

Fernandes DA, Poeta LS, Martins CAQ, et al. Balance and quality of life after total knee arthroplasty. Rev Bras Ortop. 2018;53(6):747–53. https://doi.org/10.1016/j.rbo.2017.07.007.CrossRefPubMedPubMedCentral

Tang H, Li H, Zhang S, Wang Y, Qu X, Yue B. Postoperative complications causing readmission in 30 days after total knee arthroplasty: a retrospective nested case-control study of risk factors based on propensity score matching. J Knee Surg. 2020;33(11):1100–8. https://doi.org/10.1055/s-0039-1692630.CrossRefPubMed

Chan EY, Blyth FM, Nairn L, Fransen M. Acute postoperative pain following hospital discharge after total knee arthroplasty. Osteoarthritis Cartilage. 2013;21(9):1257–63. https://doi.org/10.1016/j.joca.2013.06.011.CrossRefPubMed

Puolakka PA, Rorarius MG, Roviola M, et al. Persistent pain following knee arthroplasty. Eur J Anaesthesiol. 2010;27(5):455–60. https://doi.org/10.1097/EJA.0b013e328335b31c.CrossRefPubMed

Chapman CR, Tuckett RP, Song CW. Pain and stress in a systems perspective: reciprocal neural, endocrine, and immune interactions. J Pain. 2008;9(2):122–45. https://doi.org/10.1016/j.jpain.2007.09.006.CrossRefPubMed

Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006;367(9522):1618–25. https://doi.org/10.1016/S0140-6736(06)68700-X.CrossRefPubMed

10.

Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, et al. Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists’ Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016;17(2):131–57. https://doi.org/10.1016/j.jpain.2015.12.008.CrossRefPubMed

11.

Tu Q, Gan J, Shi J, Yu H, He S, Zhang J. Effect of transcutaneous electrical acupoint stimulation on postoperative analgesia after ureteroscopic lithotripsy: a randomized controlled trial. Urolithiasis. 2019;47(3):279–87. https://doi.org/10.1007/s00240-018-1056-8.CrossRefPubMed

12.

Hina N, Fletcher D, Poindessous-Jazat F, Martinez V. Hyperalgesia induced by low-dose opioid treatment before orthopaedic surgery: an observational case-control study. Eur J Anaesthesiol. 2015;32(4):255–61. https://doi.org/10.1097/EJA.0000000000000197.CrossRefPubMed

13.

Blevins Peratikos M, Weeks HL, Pisansky AJB, Yong RJ, Stringer EA. Effect of preoperative opioid use on adverse outcomes, medical spending, and persistent opioid use following elective total joint arthroplasty in the United States: a large retrospective cohort study of administrative claims data. Pain Med. 2020;21(3):521–31. https://doi.org/10.1093/pm/pnz083.CrossRefPubMed

14.

Jain N, Brock JL, Malik AT, Phillips FM, Khan SN. Prediction of complications, readmission, and revision surgery based on duration of preoperative opioid use: analysis of major joint replacement and lumbar fusion. J Bone Joint Surg Am. 2019;101(5):384–91. https://doi.org/10.2106/JBJS.18.00502.CrossRefPubMed

15.

Rozell JC, Courtney PM, Dattilo JR, Wu CH, Lee GC. Preoperative opiate use independently predicts narcotic consumption and complications after total joint arthroplasty. J Arthroplasty. 2017;32(9):2658–62. https://doi.org/10.1016/j.arth.2017.04.002.CrossRefPubMed

16.

Bell KL, Shohat N, Goswami K, et al. Preoperative opioids increase the risk of periprosthetic joint infection after total joint arthroplasty. J Arthroplasty. 2018;33(10):3246–3251.e1.CrossRef

17.

Nguyen LC, Sing DC, Bozic KJ. Preoperative reduction of opioid use before total joint arthroplasty. J Arthroplasty. 2016;31(9):282–7. https://doi.org/10.1016/j.arth.2016.01.068.CrossRefPubMed

18.

Cozowicz C, Olson A, Poeran J, Mörwald EE, Zubizarreta N, Girardi FP, et al. Opioid prescription levels and postoperative outcomes in orthopedic surgery. Pain. 2017;158(12):2422–30. https://doi.org/10.1097/j.pain.0000000000001047.CrossRefPubMed

19.

Starr J, Rozet I, Ben-Ari A. A risk calculator using preoperative opioids for prediction of total knee revision arthroplasty. Clin J Pain. 2018;34(4):328–31. https://doi.org/10.1097/AJP.0000000000000544.CrossRefPubMed

20.

Weick J, Bawa H, Dirschl DR, Luu HH. Preoperative opioid use is associated with higher readmission and revision rates in total knee and total hip arthroplasty. J Bone Joint Surg Am. 2018;100(14):1171–6. https://doi.org/10.2106/JBJS.17.01414.CrossRefPubMed

21.

Goplen CM, Verbeek W, Kang SH, Jones CA, Voaklander DC, Churchill TA, et al. Preoperative opioid use is associated with worse patient outcomes after total joint arthroplasty: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2019;20(1):234. https://doi.org/10.1186/s12891-019-2619-8.CrossRefPubMedPubMedCentral

22.

Smith SR, Bido J, Collins JE, Yang H, Katz JN, Losina E. Impact of preoperative opioid use on total knee arthroplasty outcomes. J Bone Joint Surg Am. 2017;99(10):803–8. https://doi.org/10.2106/JBJS.16.01200.CrossRefPubMedPubMedCentral

23.

Wu J, Hu Y, Zhu Y, Yin P, Litscher G, Xu S. Systematic review of adverse effects: a further step towards modernization of acupuncture in China. Evid Based Complement Alternat Med. 2015;2015:432467–19. https://doi.org/10.1155/2015/432467.CrossRefPubMedPubMedCentral

24.

Tedesco D, Gori D, Desai KR, Asch S, Carroll IR, Curtin C, et al. Drug-free interventions to reduce pain or opioid consumption after total knee arthroplasty: a systematic review and meta-analysis. JAMA Surg. 2017;152(10):e172872. https://doi.org/10.1001/jamasurg.2017.2872.CrossRefPubMedPubMedCentral

25.

Jung JY, Cho JH, Chung SH. Acupuncture for postoperative pain following total knee arthroplasty: a systematic review protocol. BMJ Open. 2015;5(11):e009573. https://doi.org/10.1136/bmjopen-2015-009573.CrossRefPubMedPubMedCentral

26.

Liu Q, Liu Y, Bian J, Li Q, Zhang Y. The preemptive analgesia of pre-electroacupuncture in rats with formalin-induced acute inflammatory pain. Mol Pain. 2019;15:1744806919866529. https://doi.org/10.1177/1744806919866529.CrossRefPubMedPubMedCentral

27.

Yen CM, Wu TC, Hsieh CL, Huang YW, Lin YW. Distal electroacupuncture at the LI4 acupoint reduces CFA-induced inflammatory pain via the brain TRPV1 signaling pathway. Int J Mol Sci. 2019;20(18):4471. https://doi.org/10.3390/ijms20184471.CrossRefPubMedCentral

28.

Huang H, Song X, Zhao L, Zheng L, Xiao L, Chen Y. Opposing needling for analgesia and rehabilitation after unilateral total knee arthroplasty: a randomized, sham-controlled trial protocol. Trials. 2020;21(1):385. https://doi.org/10.1186/s13063-020-04251-z.CrossRefPubMedPubMedCentral

29.

Mikashima Y, Takagi T, Tomatsu T, Horikoshi M, Ikari K, Momohara S. Efficacy of acupuncture during post-acute phase of rehabilitation after total knee arthroplasty. J Tradit Chin Med. 2012;32(4):545–8. https://doi.org/10.1016/S0254-6272(13)60068-0.CrossRefPubMed

30.

Miura K, Ohara T, Zeredo JL, Okada Y, Toda K, Sumikawa K. Effects of traditional “Juci” (contralateral acupuncture) on orofacial nociceptive behavior in the rat. J Anesth. 2007;21(1):31–6. https://doi.org/10.1007/s00540-006-0443-4.CrossRefPubMed

31.

Fan G, Wu X, Xue Z. Application of healthy-side needling to treatment of apoplectic hemiplegia. J Tradit Chin Med. 2002;22(2):143–7.PubMed

32.

Yi M, Zhang H, Lao L, Xing GG, Wan Y. Anterior cingulate cortex is crucial for contra- but not ipsi-lateral electro-acupuncture in the formalin-induced inflammatory pain model of rats. Mol Pain. 2011;7:61. https://doi.org/10.1186/1744-8069-7-61.CrossRefPubMedPubMedCentral

33.

Zhang S, Wang X, Yan CQ, Hu SQ, Huo JW, Wang ZY, et al. Different mechanisms of contralateral- or ipsilateral-acupuncture to modulate the brain activity in patients with unilateral chronic shoulder pain: a pilot fMRI study. J Pain Res. 2018;11:505–14. https://doi.org/10.2147/JPR.S152550.CrossRefPubMedPubMedCentral

34.

Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7. https://doi.org/10.7326/0003-4819-158-3-201302050-00583.CrossRefPubMedPubMedCentral

35.

MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. J Altern Complement Med. 2010;16(10):ST1–14. https://doi.org/10.1089/acm.2010.1610.CrossRefPubMed

36.

Saklad M. Grading of patients for surgical procedures | anesthesiology | asa publications. Anesthesiology. 1941;2(3):281–4. https://doi.org/10.1097/00000542-194105000-00004.CrossRef

37.

Desmond JE, Glover GH. Estimating sample size in functional MRI (fMRI) neuroimaging studies: statistical power analyses. J Neurosci Methods. 2002;118(2):115–28. https://doi.org/10.1016/S0165-0270(02)00121-8.CrossRefPubMed

38.

Hayasaka S, Peiffer AM, Hugenschmidt CE, et al. Power and sample size calculation for neuroimaging studies by non-central random field theory. NeuroImage. 2007;37(3):721–30. https://doi.org/10.1016/j.neuroimage.2007.06.009.CrossRefPubMed

39.

Jenkins M. A new standard international acupuncture nomenclature. Acupunct Med. 1990;7(1):21–2. https://doi.org/10.1136/aim.7.1.21.CrossRef

40.

Reynaud V, Verdilos A, Pereira B, Boisgard S, Costes F, Coudeyre E. Core outcome measurement instruments for clinical trials of total knee arthroplasty: a systematic review. J Clin Med. 2020;9(8):2439. https://doi.org/10.3390/jcm9082439.CrossRefPubMedCentral

41.

Briones-Cantero M, Fernández-de-Las-Peñas C, Lluch-Girbés E, et al. Effects of adding motor imagery to early physical therapy in patients with knee osteoarthritis who had received total knee arthroplasty: a randomized clinical trial. Pain Med. 2020;21(12):3548–55. https://doi.org/10.1093/pm/pnaa103.CrossRefPubMed

42.

Guérard O, Dufort S, Forget Besnard L, Gougeon A, Carlesso L. Comparing the association of widespread pain, multi-joint pain and low back pain with measures of pain sensitization and function in people with knee osteoarthritis. Clin Rheumatol. 2020;39(3):873–9. https://doi.org/10.1007/s10067-019-04828-3.CrossRefPubMed

43.

Hansen S, Vaegter HB, Petersen KK. Pretreatment exercise-induced hypoalgesia is associated with change in pain and function after standardized exercise therapy in painful knee osteoarthritis. Clin J Pain. 2020;36(1):16–24. https://doi.org/10.1097/AJP.0000000000000771.CrossRefPubMed

44.

Leung YY, Lim Z, Fan Q, Wylde V, Xiong S, Yeo SJ, et al. Pre-operative pressure pain thresholds do not meaningfully explain satisfaction or improvement in pain after knee replacement: a cohort study. Osteoarthritis Cartilage. 2019;27(1):49–58. https://doi.org/10.1016/j.joca.2018.09.003.CrossRefPubMed

45.

Jang JH, Park WH, Kim HI, Chang SO. Ways of Reasoning Used by Nurses in Postoperative Pain Assessment.Pain Manag Nurs. 2020;21(4):379–85. https://doi.org/10.1016/j.apnr.2017.08.003

46.

Au KY, Chen H, Lam WC, Chong CO, Lau A, Vardhanabhuti V, et al. Sinew acupuncture for knee osteoarthritis: study protocol for a randomized sham-controlled trial. BMC Complement Altern Med. 2018;18(1):133. https://doi.org/10.1186/s12906-018-2195-8.CrossRefPubMedPubMedCentral

47.

Unver B, Baris RH, Yuksel E, Cekmece S, Kalkan S, Karatosun V. Reliability of 4-meter and 10-meter walk tests after lower extremity surgery. Disabil Rehabil. 2017;39(25):2572–6. https://doi.org/10.1080/09638288.2016.1236153.CrossRefPubMed

48.

Becker S, Bergamo F, Schnake K. J et al. The relationship between functionality and erector spinae activity in patients with specific low back pain during dynamic and static movements. Gait Posture. 2018;66:208–13. https://doi.org/10.1016/j.gaitpost.2018.08.042.CrossRefPubMed

49.

Nawasreh ZH, Marmon AR, Logerstedt D, Snyder-Mackler L. The effect of training on a compliant surface on muscle activation and co-contraction after anterior cruciate ligament injury. Int J Sports Phys Ther. 2019;14(4):3554–63. https://doi.org/10.26603/ijspt20190554.CrossRefPubMedPubMedCentral

50.

Batista JP, Facci LM, Pelegrinelli ARM, et al. Joint angle and movement velocity effects on muscle activity of elderly with knee osteoarthritis - categorized and probabilistic analysis. J Electromyogr Kinesiol. 2018;41:50–9. https://doi.org/10.1016/j.jelekin.2018.04.014.CrossRefPubMed

51.

Elfering A, Käser A, Melloh M. Relationship between depressive symptoms and acute low back pain at first medical consultation, three and six weeks of primary care. Psychol Health Med. 2014;19(2):235–46. https://doi.org/10.1080/13548506.2013.780131.CrossRefPubMed

52.

Zhao YH, Xu Y. Effect of comprehensive nursing based on cognitive behavior on psychological function of glioma patients. Neuropsychiatr Dis Treat. 2021;17:777–85. https://doi.org/10.2147/NDT.S286164.CrossRefPubMedPubMedCentral

53.

Taylor R, Lovibond PF, Nicholas MK, Cayley C, Wilson PH. The utility of somatic items in the assessment of depression in patients with chronic pain: a comparison of the Zung Self-Rating Depression Scale and the Depression Anxiety Stress Scales in chronic pain and clinical and community samples. Clin J Pain. 2005;21(1):91–100. https://doi.org/10.1097/00002508-200501000-00011.CrossRefPubMed

54.

Leiss F, Götz JS, Maderbacher G, et al. Pain management of unicompartmental (UKA) vs. total knee arthroplasty (TKA) based on a matched pair analysis of 4144 cases. Sci Rep. 2020;10(1):17660.CrossRef

55.

Backstein D, In TKA. Preoperative systemic steroids reduced pain and nausea at 24 hours after surgery; postoperative administration reduced pain and nausea at 48 hours. J Bone Joint Surg Am. 2020;102(10):908. https://doi.org/10.2106/JBJS.20.00256.CrossRefPubMed

56.

Lewis C, Gunta K, Mitchell K, Bobay K. Effectiveness of multimodal pain management protocol in total knee arthroplasty patients. Orthop Nurs. 2012;31(3):153–9. https://doi.org/10.1097/NOR.0b013e3182558d0b.CrossRefPubMed

57.

Feng JE, Novikov D, Anoushiravani AA, Schwarzkopf R. Total knee arthroplasty: improving outcomes with a multidisciplinary approach. J Multidiscip Healthc. 2018;11:63–73. https://doi.org/10.2147/JMDH.S140550.CrossRefPubMedPubMedCentral

58.

Kim B, Lohman E, Yim J. Acupuncture-like transcutaneous electrical nerve stimulation for pain, function, and biochemical inflammation after total knee arthroplasty. Altern Ther Health Med. 2021;27(1):28–34.PubMed

59.

Xiong J, Li H, Li X, Wang L, Zhao P, Meng D, et al. Electroacupuncture for postoperative pain management after total knee arthroplasty: protocol for a systematic review and meta-analysis. Medicine (Baltimore). 2018;97(9):e0014. https://doi.org/10.1097/MD.0000000000010014.CrossRefPubMedPubMedCentral

60.

Jiang Y, Yang S, Tao J, et al. Opposing needling promotes behavior recovery and exerts neuroprotection via the cAMP/PKA/CREB signal transduction pathway in transient MCAO rats. Mol Med Rep. 2016;13(3):2060–70. https://doi.org/10.3892/mmr.2016.4773.CrossRefPubMedPubMedCentral

61.

Leuthardt EC, Allen M, Kamran M, Hawasli AH, Snyder AZ, Hacker CD, et al. Resting-state blood oxygen level-dependent functional MRI: a paradigm shift in preoperative brain mapping. Stereotact Funct Neurosurg. 2015;93(6):427–39. https://doi.org/10.1159/000442424.CrossRefPubMed

62.

Colombo B, Rocca MA, Messina R, et al. Resting-state fMRI functional connectivity: a new perspective to evaluate pain modulation in migraine. Neurol Sci. 2015;null:41–5.CrossRef

63.

Caria A, Sitaram R, Birbaumer N. Real-time fMRI: a tool for local brain regulation. Neuroscientist. 2012;18(5):487–501. https://doi.org/10.1177/1073858411407205.CrossRefPubMed

64.

Huang W, Pach D, Napadow V, Park K, Long X, Neumann J, et al. Characterizing acupuncture stimuli using brain imaging with FMRI--a systematic review and meta-analysis of the literature. PLoS ONE. 2012;7(4):e32960. https://doi.org/10.1371/journal.pone.0032960.CrossRefPubMedPubMedCentral

65.

Jin L, Sun J, Xu Z, Yang X, Liu P, Qin W. Intersubject synchronisation analysis of brain activity associated with the instant effects of acupuncture: an fMRI study. Acupunct Med. 2018;36(1):14–20. https://doi.org/10.1136/acupmed-2016-011327.CrossRefPubMed

Title: Cerebral mechanism of opposing needling for managing acute pain after unilateral total knee arthroplasty: study protocol for a randomized, sham-controlled clinical trial
Authors: Chi Zhao
Hui Xu
Xinyu A
Bingxin Kang
Jun Xie
Jun Shen
Songtao Sun
Sheng Zhong
Chenxin Gao
Xirui Xu
Youlong Zhou
Lianbo Xiao
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Acupuncture
Magnetic Resonance Imaging
Magnetic Resonance Imaging
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06066-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Cerebral mechanism of opposing needling for managing acute pain after unilateral total knee arthroplasty: study protocol for a randomized, sham-controlled clinical trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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