Efficacy of Electroacupuncture Therapy in Patients With Postherpetic Neuralgia: Study Protocol for a Multicentre, Randomized, Controlled, Assessor-Blinded Trial

Hantong Hu, Yejing Shen, Xinwei Li, Hongfang Tian, XingLing Li, Yang Li, Yingying Cheng, Lei Wu, Dexiong Han, Hantong Hu, Yejing Shen, Xinwei Li, Hongfang Tian, XingLing Li, Yang Li, Yingying Cheng, Lei Wu, Dexiong Han

Abstract

Introduction: The efficacy of conventional treatments for treating postherpetic neuralgia (PHN) remains unsatisfactory. Thus, this multicentre, randomized controlled, assessor-blinded trial aims to investigate the efficacy and safety of electroacupuncture (EA) therapy in patients with PHN. Methods and Analysis: This multicentre randomized controlled trial will enroll 132 patients with PHN from 3 hospitals. All patients will be randomly assigned to either the EA combined with medication group or medication group through a computerized central randomization system in a 1:1 ratio. Outcome measures will be assessed before intervention, at 2, 4, 6 weeks after intervention and at the end of 8-week follow-up. Primary outcomes will be sensory thresholds and pain intensity. Secondary outcomes will include dosage of analgetic, quality of life, anxiety, and depression severity and sleep quality. All adverse effects will be assessed during the trial. Conclusions: This study will provide evidence to ascertain whether EA is effective and safe for treating PHN. Ethics and Dissemination: Ethics approval (No.ZSLL-KY-2017-025) has been obtained from the Ethics Committee of The Third Affiliated Hospital of Zhejiang Chinese Medical University. Informed consent will be signed prior to subject enrolment. The results will be submitted to international peer-reviewed journals and presented at international conferences. Trial Registration Number: The study protocol has been registered in the clinicaltrials registry with the identification code NCT04594226.

Keywords: electroacupuncture; pain; postherpetic neuralgia; protocol; randomized controlled trial.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Hu, Shen, Li, Tian, Li, Li, Cheng, Wu and Han.

Figures

Figure 1
Figure 1
Flow chart of the study process. EA, electroacupuncture; HADS, Hospital Anxiety and Depression Scale; PSQI, Pittsburgh Sleep Quality Index; QST, Quantitative Sensory Testing; SF-36, Short Form 36 Health Survey; ZBPI, Zoster Brief Pain Inventory.

References

    1. Johnson RW, Rice AS. Clinical practice. Postherpetic neuralgia. N Engl J Med. (2014) 371:1526–33. 10.1056/NEJMcp1403062
    1. Rowbotham MC, Davies PS, Fields HL. Topical lidocaine gel relieves postherpetic neuralgia. Ann Neurol. (1995) 37:246–53. 10.1002/ana.410370216
    1. Kawai K, Gebremeskel BG, Acosta CJ. Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ Open. (2014) 4:e004833. 10.1136/bmjopen-2014-004833
    1. Lin CS, Lin YC, Lao HC, Chen CC. Interventional treatments for postherpetic neuralgia: a systematic review. Pain Physician. (2019) 22:209–28. 10.36076/ppj/2019.22.209
    1. Qaseem A, Wilt TJ, McLean RM, Forciea MA. Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the american college of physicians. Ann Intern Med. (2017) 166:514–30. 10.7326/M16-2367
    1. Tsai SL, Fox LM, Murakami M, Tsung JW. Auricular acupuncture in emergency department treatment of acute pain. Ann Emerg Med. (2016) 68:583–5. 10.1016/j.annemergmed.2016.05.006
    1. Quinlan-Woodward J, Gode A, Dusek JA, Reinstein AS, Johnson JR, Sendelbach S. Assessing the impact of acupuncture on pain, nausea, anxiety, and coping in women undergoing a mastectomy. Oncol Nurs Forum. (2016) 43:725–32. 10.1188/16.ONF.725-732
    1. Hui F, Boyle E, Vayda E, Glazier RH. A randomized controlled trial of a multifaceted integrated complementary-alternative therapy for chronic herpes zoster-related pain. Altern Med Rev. (2012) 17:57–68.
    1. Liu K, Zeng J, Pei W, Chen S, Luo Z, Lu L, et al. . Assessing the reporting quality in randomized controlled trials of acupuncture for postherpetic neuralgia using the CONSORT statement and STRICTA guidelines. J Pain Res. (2019) 12:2359–70. 10.2147/JPR.S210471
    1. Li W, Peng W, Zhou J, Liu Z. Acupuncture for postherpetic neuralgia: a systematic review protocol. BMJ Open. (2014) 4:e005725. 10.1136/bmjopen-2014-005725
    1. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. . CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. (2010) 340:c869. 10.1136/bmj.c869
    1. 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) 158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Mücke M, Cuhls H, Radbruch L, Baron R, Maier C, Tölle T, et al. . Quantitative sensory testing (QST). English version. Schmerz. (2016) 28:635–48. 10.1007/s00482-015-0093-2
    1. Kramer S, Baeumler P, Geber C, Fleckenstein J, Simang M, Haas L, et al. . Somatosensory profiles in acute herpes zoster and predictors of postherpetic neuralgia. Pain. (2019) 160:882–94. 10.1097/j.pain.0000000000001467
    1. Fleckenstein J, Kramer S, Hoffrogge P, Thoma S, Lang PM, Lehmeyer L, et al. . Acupuncture in acute herpes zoster pain therapy (ACUZoster) - design and protocol of a randomised controlled trial. BMC Complement Altern Med. (2009) 9:31. 10.1186/1472-6882-9-31
    1. Rolke R, Baron R, Maier C, Tölle TR, Treede DR, Beyer A, et al. . Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. (2006) 123:231–43. 10.1016/j.pain.2006.01.041
    1. Coplan PM, Schmader K, Nikas A, Chan IS, Choo P, Levin MJ, et al. . Development of a measure of the burden of pain due to herpes zoster and postherpetic neuralgia for prevention trials: adaptation of the brief pain inventory. J Pain. (2004) 5:344–56. 10.1016/j.jpain.2004.06.001
    1. Bruxvoort KJ, Liang AS, Harpaz R, Qian L, Sy LS, LaRussa P, et al. . Patient report of herpes zoster pain: Incremental benefits of zoster vaccine live. Vaccine. (2019) 37:3478–84. 10.1016/j.vaccine.2019.04.095
    1. Putri Mellaratna W, Jusuf NK, Yosi A. The impact of pain intensity on quality of life of postherpetic neuralgia patients. Med Glas. (2020) 17:439–44. 10.17392/1111-20
    1. Doth AH, Hansson PT, Jensen MP, Taylor RS. The burden of neuropathic pain: a systematic review and meta-analysis of health utilities. Pain. (2010) 149:338–44. 10.1016/j.pain.2010.02.034
    1. Galluzzi KE. Management strategies for herpes zoster and postherpetic neuralgia. J Am Osteopath Assoc. (2007) 107:S8–13.
    1. Pei W, Zeng J, Lu L, Lin G, Ruan J. Is acupuncture an effective postherpetic neuralgia treatment? A systematic review and meta-analysis. J Pain Res. (2019) 12:2155–65. 10.2147/JPR.S199950
    1. Wang Y, Li W, Peng W, Zhou J, Liu Z. Acupuncture for postherpetic neuralgia: systematic review and meta-analysis. Medicine. (2018) 97:e11986. 10.1097/MD.0000000000011986
    1. Ruengwongroj P, Muengtaweepongsa S, Patumanond J, Phinyo P. Effectiveness of press needle treatment and electroacupuncture in patients with postherpetic neuralgia: a matched propensity score analysis. Complement Ther Clin Pract. (2020) 40:101202. 10.1016/j.ctcp.2020.101202
    1. Zeng Y, Wei ZG, Ren YJ, Gou L, Zhou R. Treatment of 62 cases of postherpetic neuralgia by electroacupuncture at Jiaji acupoints combined with surround needlin. Yunnan J Traditional Chinese Med. (2016) 37:89–90. 10.16254/j.cnki.53-1120/r.2016.12.047
    1. Wang L, Qiu L, Zheng X, Ouyang J, Zhang M, He L, et al. . Effectiveness of electroacupuncture at Jiaji acupoints (EX-B2), plus moxibustion and intermediate on postherpetic neuralgia: a randomized controlled trial. J Tradit Chin Med. (2020) 40:121–7.
    1. Garrido-Suárez B, Garrido G, Menéndex A, Hernández-Arteaga M, Delgado-Hernández R. Combination of low frequency electroacupuncture plus subdissociative doses of ketamine in post-herpetic neuralgia patients. A pilot study. J Pharmacy Pharmacognosy Res. (2017) 5:381–93. Available online at:
    1. Li W, Cai G, Wang Y. Clinical observation of 30 cases of PHN with electroacupuncture and bloodletting. Mod Diagn Treat. (2014) 25:1506–7. 10.1016/j.wjam.2020.07.007
    1. Liu Y, Zhang QA, Wu YY, Shi Y, Fang JQ, Han DX. Efficacy and safety of electroacupuncture for postherpetic neuralgia: a systematic review and meta- analysis. J Guangzhou University Traditional Chinese Med. (2020) 37:2472–80. 10.13359/j.cnki.gzxbtcm.2020.12.036
    1. Wang TQ, Li YT, Wang LQ, Shi GX, Tu JF. Electroacupuncture versus manual acupuncture for knee osteoarthritis: a randomized controlled pilot trial. Acupunct Med. (2020) 38:291–300. 10.1177/0964528419900781
    1. Shi GX, Tu JF. Effect of Electro-Acupuncture (EA) and Manual Acupuncture (MA) on Markers of Inflammation in Knee Osteoarthritis. J Pain Res. (2020) 13:2171–9. 10.2147/JPR.S256950
    1. Zhang R, Lao L, Ren K, Berman BM. Mechanisms of acupuncture-electroacupuncture on persistent pain. Anesthesiology. (2014) 120:482–503. 10.1097/ALN.0000000000000101
    1. Zou J, Dong X, Wang K, Shi J, Sun N. Electroacupuncture inhibits autophagy of neuron cells in postherpetic neuralgia by increasing the expression of miR-223-3p. Biomed Res Int. (2021) 2021:6637693. 10.1155/2021/6637693
    1. Wu CH, Mao HR, Li HP, Yuan XC, Xiang HC, Zhu H, et al. . Stimulating frequency-dependent analgesic effect of electroacupuncture via down-regulating expression of VEGF in dorsal horns of lumbar spinal cord in post herpetic neuralgia rats. Acupuncture Res. (2018) 43:203–8. 10.13702/j.1000-0607.170926
    1. Wu CH, Lv ZT, Zhao Y, Gao Y, Li JQ, Gao F, et al. . Electroacupuncture improves thermal and mechanical sensitivities in a rat model of postherpetic neuralgia. Mol Pain. (2013) 9:18. 10.1186/1744-8069-9-18
    1. Li HP, Su W, Shu Y, Yuan XC, Lin LX, Hou TF, et al. . Electroacupuncture decreases Netrin-1-induced myelinated afferent fiber sprouting and neuropathic pain through μ-opioid receptors. J Pain Res. (2019) 12:1259–68. 10.2147/JPR.S191900
    1. Han JS. Acupuncture: neuropeptide release produced by electrical stimulation of different frequencies. Trends Neurosci. (2003) 26:17–22. 10.1016/S0166-2236(02)00006-1
    1. Wang Y, Dong CF, Xu RN, Guo ZN, Zheng LL, Yuan YM. Effect of electroacupuncture at Jiaji (EX-B 2) points combined with nerve mobilization on motor function and mRNA and protein expression of RhoA in rabbits with sciatic nerve injury. Chinese Acupuncture Moxibustion. (2019) 39:625–31. 10.13703/j.0255-2930.2019.06.016
    1. Zhuang Z, Jiang G. Thirty cases of the blood-stasis type prolapse of lumbar intervertebral disc treated by acupuncture at the xi (cleft) point plus herbal intervention injection. J Tradit Chin Med. (2008) 28:178–82. 10.1016/S0254-6272(08)60041-2
    1. Koog YH. Effect of placebo acupuncture over no-treatment: A simple model incorporating the placebo and nocebo effects. Complement Ther Med. (2016) 24:69–72. 10.1016/j.ctim.2015.12.007
    1. Lee YS, Chae Y. Powerful effects of placebo needles. Acupunct Med. (2018) 36:197–8. 10.1136/acupmed-2017-011516
    1. Chae Y, Lee YS, Enck P. How placebo needles differ from placebo pills? Front Psychiatr. (2018) 9:243. 10.3389/fpsyt.2018.00243
    1. Hu H, Hu T, Han D, Gao H. Establishment of appropriate sham acupuncture and successful patient blinding. Acupunct Med. (2021) 39:159–60. 10.1177/0964528420924035

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