Double-blind acupuncture needles: a multi-needle, multi-session randomized feasibility study

Judith M Schlaeger, Nobuari Takakura, Hiroyoshi Yajima, Miho Takayama, Alana D Steffen, Elizabeth M Gabzdyl, Robyn A Nisi, Kathleen McGowan Gruber, Jason M Bussell, Diana J Wilkie, Judith M Schlaeger, Nobuari Takakura, Hiroyoshi Yajima, Miho Takayama, Alana D Steffen, Elizabeth M Gabzdyl, Robyn A Nisi, Kathleen McGowan Gruber, Jason M Bussell, Diana J Wilkie

Abstract

Background: Efficacy of acupuncture is difficult to demonstrate without a feasible double-blind milieu. Double-blind acupuncture needles have been validated in single session protocols with one or two needles but not been tested in a protocol requiring many needles and repeated sessions.

Methods: We determined the feasibility of a 13-needle, 10-session study protocol. Feasibility focused on (1) enrolling and retaining participants; (2) two acupuncturists accurately implementing a double-blind, multi-needle, multi-session protocol; (3) participants completing measures; and (4) protocol acceptability to participants. In this double-blind randomized controlled pilot study, participants were randomized 1:1 to a penetrating needle group or a skin-touch placebo control group.

Results: Six women with vulvodynia (mean age 31.5 ± 8 years; five white, non-Latina, one black/African American) met the eligibility requirements, consented to participation, and were enrolled. All six participants (100%) completed the 10-session study protocol in 5 weeks without missing any treatment sessions. Per observed checklist documented technique, two acupuncturists flawlessly administered the 13-needle, 10-session acupuncture protocol; no needles malfunctioned. Six participants attended all sessions and completed 99% of measurement items. One participant did not like acupuncture (60% acceptability score) and five liked acupuncture (100% acceptability scores); the mean acceptability score was 93.3%.

Conclusion: Study feasibility was supported. This protocol can be used in a double-blind efficacy trial of acupuncture for vulvodynia.

Trial registration: ClinicalTrials.gov, NCT02704234. Registered 30 November 2015.

Keywords: Acupuncture; Double-blind acupuncture needles; Pain; Placebo; Provoked vestibulodynia; Vulvar vestibulitis; Vulvodynia.

Conflict of interest statement

This study was approved by the University of Illinois at Chicago Institutional Review Board protocol number 2015-0692.Written consent was obtained by the subject portrayed in Fig. 3.N.T. and the Educational Foundation of Hanada Gakuen possess a US patent 6575992B1, a Canadian patent CA 2339223, a Korean patent 0478177, a Taiwan patent 150135, a Chinese patent ZL00800894.9 (Title: Safe needle, placebo needle and needle set for double blind), and two Japanese patents 4061397 (Title: Placebo needle, and needle set for double-blinding) and 4315353 (Title: Safe needle) on the needles described in this abstract. N.T. is a salaried employee of the Educational Foundation of Hanada Gakuen. The remaining authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Standardized acupuncture protocol for the treatment of vulvodynia [13]; figure reprinted with permission from The Journal of Chinese Medicine
Fig. 2
Fig. 2
Mechanisms of double-blind acupuncture needles: penetrating and skin-touch placebo
Fig. 3
Fig. 3
Inserted double-blind needles with inner guide tubes and pedestals
Fig. 4
Fig. 4
Consort flow diagram

References

    1. Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet. 1998;352(9125):364–365. doi: 10.1016/S0140-6736(97)10471-8.
    1. Park J, White A, Lee H, Ernst E. Development of a new sham needle. Acupunct Med. 1999;17(2):110–112. doi: 10.1136/aim.17.2.110.
    1. Tavel ME. The placebo effect: the good, the bad, and the ugly. Am J Med. 2014;127(6):484–488. doi: 10.1016/j.amjmed.2014.02.002.
    1. Takakura N, Yajima H. A double-blind placebo needle for acupuncture research. BMC Complement Altern Med. 2007;7:31. doi: 10.1186/1472-6882-7-31.
    1. Zhu D, Gao Y, Chang J, Kong J. Placebo acupuncture devices: considerations for acupuncture research. Evid Based Complement Alternat Med. 2013;2013:628907.
    1. Takakura N, Takayama M, Kawase A, Kaptchuk TJ, Yajima H. Double-blind acupuncture needle: a potential tool to investigate the nature of pain and pleasure. ISRN Pain. 2013;2013. .
    1. Takakura N, Takayama M, Kawase A, Yajima H. Double-blind acupuncture needling: does patient reaction reveal needle authenticity? Medical Acupuncture. 2008;20(3):169–174. doi: 10.1089/acu.2008.0629.
    1. Takakura N, Takayama M, Kawase A, Yajima H. Double blinding with a new placebo needle: a validation study on participant blinding. Acupunct Med. 2011;29(3):203–207. doi: 10.1136/aim.2010.002857.
    1. Takakura N, Yajima H. A placebo acupuncture needle with potential for double blinding—a validation study. Acupunct Med. 2008;26(4):224–230. doi: 10.1136/aim.26.4.224.
    1. Takakura N, Yajima H. Analgesic effect of acupuncture needle penetration: a double-blind crossover study. Open Med. 2009;3(2):e54–e61.
    1. Takayama Miho, Yajima Hiroyoshi, Kawase A. Medicines | Free Full-Text | The potential of double blinding with two placebo acupuncture needles: a randomized controlled pilot-trial [Internet]. [cited 2015 Jan 11]. Available from:
    1. Vase L, Baram S, Takakura N, Takayama M, Yajima H, Kawase A, et al. Can acupuncture treatment be double-blinded? An evaluation of double-blind acupuncture treatment of postoperative pain. PLoS One. 2015;10(3):e0119612. doi: 10.1371/journal.pone.0119612.
    1. Schlaeger JM, Xu N, Mejta CL, Park CG, Wilkie DJ. Acupuncture for the treatment of vulvodynia: a randomized wait-list controlled pilot study. J Sex Med. 2015;12(4):1019–1027. doi: 10.1111/jsm.12830.
    1. Huang T, Zhang W, Jia S, Tian Y, Wang G, Yang L, et al. A transcontinental pilot study for acupuncture lifting-thrusting and twisting-rotating manipulations. Evid Based Complement Alternat Med [Internet]. 2012 [cited 2017 Sep 14];2012. Available from:
    1. Han Y-J, Yi S-Y, Lee Y-J, Kim K-H, Kim E-J, Lee S-D. Quantification of the parameters of twisting-rotating acupuncture manipulation using a needle force measurement system. Integrative Medicine Research. 2015;4(2):57–65. doi: 10.1016/j.imr.2015.04.003.
    1. Wilkie DJ, Huang HY, Berry DL, Schwartz A, Lin YC, Ko NY, et al. Cancer symptom control: feasibility of a tailored, interactive computerized program for patients. Fam Community Health. 2001;24(3):48–62. doi: 10.1097/00003727-200110000-00007.
    1. Wilkie DJ, Savedra MC, Holzemer WL, Tesler MD, Paul SM. Use of the McGill Pain Questionnaire to measure pain: a meta-analysis. Nurs Res. 1990;39(1):36–41. doi: 10.1097/00006199-199001000-00008.
    1. Wilkie DJ, Judge MKM, Berry DL, Dell J, Zong S, Gilespie R. Usability of a computerized PAINReportIt in the general public with pain and people with cancer pain. J Pain Symptom Manag. 2003;25(3):213–224. doi: 10.1016/S0885-3924(02)00638-3.
    1. Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, et al. The female sexual function index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26(2):191–208. doi: 10.1080/009262300278597.
    1. Brazier JE, Harper R, Jones NM, O’Cathain A, Thomas KJ, Usherwood T, et al. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992;305(6846):160–164. doi: 10.1136/bmj.305.6846.160.
    1. Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193–213. doi: 10.1016/0165-1781(89)90047-4.
    1. Stockdale CK, Lawson HW. 2013 Vulvodynia Guideline update. J Low Genit Tract Dis. 2014;18(2):93–100. doi: 10.1097/LGT.0000000000000021.
    1. Nguyen RHN, Mathur C, Wynings EM, Williams DA, Harlow BL. Remission of vulvar pain among women with primary vulvodynia. J Low Genit Tract Dis. 2015;19(1):62–67. doi: 10.1097/LGT.0000000000000041.
    1. Alderman L. Acupuncture may help, but you’ll need to pay. The New York Times [Internet]. 2010 May 7 [cited 2017 May 25]; Available from:
    1. Ong LM, de Haes JC, Hoos AM, Lammes FB. Doctor-patient communication: a review of the literature. Soc Sci Med. 1995;40(7):903–918. doi: 10.1016/0277-9536(94)00155-M.

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