EA for BPS: An RCT and Study for Central Mechanism

Summary

This is a randomized controlled and assessor-blinded design trial to evaluate the efficacy and safety of acupuncture for bladder pain syndrome(BPS). All eligible participants will be randomly assigned to the medication group(n=21), EA group(n=42) and SA group(n=21) in a 1:2:1 allocation ratio. Participants will receive 4-week treatments phase followed by a 4-week follow-up phase. Outcomes will be assessed at baseline, during the treatment and at the end of the follow-up. Outcome assessors, data managers and statisticians will be blinded to the group allocation, while acupuncturists and participants will not be blinded for obvious reasons. Besides, fMRI will be used to collect spontaneous electrical activity of the brain of patients. In this trial, the investigators assume that electroacupuncture for BPS, compared to amitriptyline, is instrumental in improving symptoms such as pain, frequent micturition and emotional disorder.

Timeline

Start

2022-03-16

Primary completion

2024-12-24

Completion

2025-01-23

Publications

• Background Hanno PM, Erickson D, Moldwin R, Faraday MM; American Urological Association. Diagnosis and treatment of interstitial cystitis/bladder pain syndrome: AUA guideline amendment. J Urol. 2015 May;193(5):1545-53. doi: 10.1016/j.juro.2015.01.086. Epub 2015 Jan 23.
• Background van de Merwe JP, Nordling J, Bouchelouche P, Bouchelouche K, Cervigni M, Daha LK, Elneil S, Fall M, Hohlbrugger G, Irwin P, Mortensen S, van Ophoven A, Osborne JL, Peeker R, Richter B, Riedl C, Sairanen J, Tinzl M, Wyndaele JJ. Diagnostic criteria, classification, and nomenclature for painful bladder syndrome/interstitial cystitis: an ESSIC proposal. Eur Urol. 2008 Jan;53(1):60-7. doi: 10.1016/j.eururo.2007.09.019. Epub 2007 Sep 20.
• Background Hanno PM. Re-imagining interstitial cystitis. Urol Clin North Am. 2008 Feb;35(1):91-9; vii. doi: 10.1016/j.ucl.2007.09.011.
• Background Konkle KS, Berry SH, Elliott MN, Hilton L, Suttorp MJ, Clauw DJ, Clemens JQ. Comparison of an interstitial cystitis/bladder pain syndrome clinical cohort with symptomatic community women from the RAND Interstitial Cystitis Epidemiology study. J Urol. 2012 Feb;187(2):508-12. doi: 10.1016/j.juro.2011.10.040. Epub 2011 Dec 15.
• Background Nickel JC, Payne CK, Forrest J, Parsons CL, Wan GJ, Xiao X. The relationship among symptoms, sleep disturbances and quality of life in patients with interstitial cystitis. J Urol. 2009 Jun;181(6):2555-61. doi: 10.1016/j.juro.2009.02.030. Epub 2009 Apr 16.
• Background Ouyang H, Chen JD. Review article: therapeutic roles of acupuncture in functional gastrointestinal disorders. Aliment Pharmacol Ther. 2004 Oct 15;20(8):831-41. doi: 10.1111/j.1365-2036.2004.02196.x.
• Background Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
• Background 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 Nov 1;43(6):725-732. doi: 10.1188/16.ONF.725-732.
• Background Tsai SL, Fox LM, Murakami M, Tsung JW. Auricular Acupuncture in Emergency Department Treatment of Acute Pain. Ann Emerg Med. 2016 Nov;68(5):583-585. doi: 10.1016/j.annemergmed.2016.05.006. Epub 2016 Jun 8.
• Background Wu YY, Jiang YL, He XF, Zhao XY, Shao XM, Du JY, Fang JQ. Effects of Electroacupuncture with Dominant Frequency at SP 6 and ST 36 Based on Meridian Theory on Pain-Depression Dyad in Rats. Evid Based Complement Alternat Med. 2015;2015:732845. doi: 10.1155/2015/732845. Epub 2015 Mar 4.
• Background Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
• Background Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.
• Background Thompson E. Hamilton Rating Scale for Anxiety (HAM-A). Occup Med (Lond). 2015 Oct;65(7):601. doi: 10.1093/occmed/kqv054. No abstract available.
• Background Carneiro AM, Fernandes F, Moreno RA. Hamilton depression rating scale and montgomery-asberg depression rating scale in depressed and bipolar I patients: psychometric properties in a Brazilian sample. Health Qual Life Outcomes. 2015 Apr 2;13:42. doi: 10.1186/s12955-015-0235-3.
• Background Melzer J, Rostock M, Brignoli R, Keck ME, Saller R. Preliminary data of a HAMD-17 validated symptom scale derived from the ICD-10 to diagnose depression in outpatients. Forsch Komplementmed. 2012;19(4):191-6. doi: 10.1159/000342018. Epub 2012 Aug 20.
• Background El-Hefnawy AS, Soliman HMM, Abd-Elbary SOM, Shereif WI. Long-standing nonulcerative bladder pain syndrome: Impact of Thiele massage on bladder and sexual domains. Low Urin Tract Symptoms. 2020 May;12(2):123-127. doi: 10.1111/luts.12291. Epub 2019 Oct 24.
• Background Huang MC, Hsieh CH, Chang WC, Chang ST, Lee MS. Assessment of treatment outcomes of interstitial cystitis with hydrodistention and bladder training by O'Leary-Sant Interstitial Cystitis Symptom and Problem Indices. Taiwan J Obstet Gynecol. 2018 Oct;57(5):718-721. doi: 10.1016/j.tjog.2018.08.019.
• Background Suskind AM, Berry SH, Ewing BA, Elliott MN, Suttorp MJ, Clemens JQ. The prevalence and overlap of interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome in men: results of the RAND Interstitial Cystitis Epidemiology male study. J Urol. 2013 Jan;189(1):141-5. doi: 10.1016/j.juro.2012.08.088. Epub 2012 Nov 16.
• Background McLennan MT. Interstitial cystitis: epidemiology, pathophysiology, and clinical presentation. Obstet Gynecol Clin North Am. 2014 Sep;41(3):385-95. doi: 10.1016/j.ogc.2014.05.004. Epub 2014 Jul 9.
• Background Jhang JF, Kuo HC. Pathomechanism of Interstitial Cystitis/Bladder Pain Syndrome and Mapping the Heterogeneity of Disease. Int Neurourol J. 2016 Nov;20(Suppl 2):S95-104. doi: 10.5213/inj.1632712.356. Epub 2016 Nov 22.
• Background Cox A. Management of interstitial cystitis/bladder pain syndrome. Can Urol Assoc J. 2018 Jun;12(6 Suppl 3):S157-S160. doi: 10.5489/cuaj.5324. No abstract available.
• Background Beckett MK, Elliott MN, Clemens JQ, Ewing B, Berry SH. Consequences of interstitial cystitis/bladder pain symptoms on women's work participation and income: results from a national household sample. J Urol. 2014 Jan;191(1):83-8. doi: 10.1016/j.juro.2013.07.018. Epub 2013 Jul 17.
• Background Huffman MM, Slack A, Hoke M. Bladder Pain Syndrome. Prim Care. 2019 Jun;46(2):213-221. doi: 10.1016/j.pop.2019.02.002. Epub 2019 Apr 1.
• Background Marcu I, Campian EC, Tu FF. Interstitial Cystitis/Bladder Pain Syndrome. Semin Reprod Med. 2018 Mar;36(2):123-135. doi: 10.1055/s-0038-1676089. Epub 2018 Dec 19.
• Background Rapkin AJ, Kames LD. The pain management approach to chronic pelvic pain. J Reprod Med. 1987 May;32(5):323-7.
• Background Sun Y, Liu Y, Liu B, Zhou K, Yue Z, Zhang W, Fu W, Yang J, Li N, He L, Zang Z, Su T, Fang J, Ding Y, Qin Z, Song H, Hu H, Zhao H, Mo Q, Zhou J, Wu J, Liu X, Wang W, Pang R, Chen H, Wang X, Liu Z. Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome : A Randomized Trial. Ann Intern Med. 2021 Oct;174(10):1357-1366. doi: 10.7326/M21-1814. Epub 2021 Aug 17.
• Results Lv TT, Lv JW, Wang SY, Jiang C, Gu YJ, Liu HR. [Efficacy of electroacupuncture nerve stimulation therapy for interstitial cystitis/bladder pain syndrome]. Zhongguo Zhen Jiu. 2019 May 12;39(5):467-72. doi: 10.13703/j.0255-2930.2019.05.003. Chinese.
• Results Min zhi, Hu Xiquan, Chen Xuelian, et al. Clinical Observation of Electroacupuncture Combined with Bladder Irrigation for Bladder Pain Syndrome.Shanghai Journal of Acupuncture and Moxibustion. 2020; 39(02): 192-195.
• Xu Y, Chen Y, Shi Y, Lu J, Wu Z, Liu Z, Chen Y, Ni W, Ding Q, Dai W, Wu X, Fang J, Wu Y. Electro-Acupuncture for Bladder Pain Syndrome: A Protocol of a Randomized Controlled Trial and Study for Central Mechanism. J Pain Res. 2022 Jul 13;15:1959-1970. doi: 10.2147/JPR.S370751. eCollection 2022.

Drugs

Indications