Manual and electroacupuncture for labour pain: study design of a longitudinal randomized controlled trial

Linda Vixner, Lena B Mårtensson, Elisabet Stener-Victorin, Erica Schytt, Linda Vixner, Lena B Mårtensson, Elisabet Stener-Victorin, Erica Schytt

Abstract

Introduction. Results from previous studies on acupuncture for labour pain are contradictory and lack important information on methodology. However, studies indicate that acupuncture has a positive effect on women's experiences of labour pain. The aim of the present study was to evaluate the efficacy of two different acupuncture stimulations, manual or electrical stimulation, compared with standard care in the relief of labour pain as the primary outcome. This paper will present in-depth information on the design of the study, following the CONSORT and STRICTA recommendations. Methods. The study was designed as a randomized controlled trial based on western medical theories. Nulliparous women with normal pregnancies admitted to the delivery ward after a spontaneous onset of labour were randomly allocated into one of three groups: manual acupuncture, electroacupuncture, or standard care. Sample size calculation gave 101 women in each group, including a total of 303 women. A Visual Analogue Scale was used for assessing pain every 30 minutes for five hours and thereafter every hour until birth. Questionnaires were distributed before treatment, directly after the birth, and at one day and two months postpartum. Blood samples were collected before and after the first treatment. This trial is registered at ClinicalTrials.gov: NCT01197950.

Figures

Figure 1
Figure 1
Study design including recruitment, randomization, interventions, and data collection. MA: Manual acupuncture, EA: Electroacupuncture, SC: Standard care, Q: Questionnaire.

References

    1. Birch S. Clinical research on acupuncture: part 2. Controlled clinical trials, an overview of their methods. Journal of Alternative and Complementary Medicine. 2004;10(3):481–498.
    1. Cho SH, Lee H, Ernst E. Acupuncture for pain relief in labour: a systematic review and meta-analysis. BJOG: An International Journal of Obstetrics and Gynaecology. 2010;117(8):907–920.
    1. Nesheim BI, Kinge R, Berg B, et al. Acupuncture during labor can reduce the use of meperidine: a controlled clinical study. Clinical Journal of Pain. 2003;19(3):187–191.
    1. Borup L, Wurlitzer W, Hedegaard M, Kesmodel US, Hvidman L. Acupuncture as pain relief during delivery: a randomized controlled trial. Birth. 2009;36(1):5–12.
    1. Mårtensson L, Stener-Victorin E, Wallin G. Acupuncture versus subcutaneous injections of sterile water as treatment for labour pain. Acta Obstetricia et Gynecologica Scandinavica. 2008;87(2):171–177.
    1. Hantoushzadeh S, Alhusseini N, Lebaschi AH. The effects of acupuncture during labour on nulliparous women: a randomised controlled trial. Australian and New Zealand Journal of Obstetrics and Gynaecology. 2007;47(1):26–30.
    1. Ziaei S, Hajipour L. Effect of acupuncture on labor. International Journal of Gynecology and Obstetrics. 2006;92(1):71–72.
    1. Skilnand E, Fossen D, Heiberg E. Acupuncture in the management of pain in labor. Acta Obstetricia et Gynecologica Scandinavica. 2002;81(10):943–948.
    1. Ramnerö A, Hanson U, Kihlgren M. Acupuncture treatment during labour—a randomised controlled trial. BJOG: An International Journal of Obstetrics and Gynaecology. 2002;109(6):637–644.
    1. Schytt E, Waldenstrm U. Epidural analgesia for labor pain: whose choice? Acta Obstetricia et Gynecologica Scandinavica. 2010;89(2):238–242.
    1. Hodnett ED, Gates S, Hofmeyr GJ, Sakala C. Continuous support for women during childbirth. Cochrane Database of Systematic Reviews (Online) 2011;(3) Article ID CD003766.
    1. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ: British Medical Journal. 2010;340(1, article c869)
    1. Macpherson H, Altman DG, Hammerschlag R, et al. Revised standards for reporting interventions in clinical trials of acupuncture (stricta): extending the consort statement. PLoS Medicine. 2010;7(6, article e1000261)
    1. Li AH, Zhang JM, Xie YK. Human acupuncture points mapped in rats are associated with excitable muscle/skin-nerve complexes with enriched nerve endings. Brain Research. 2004;1012(1-2):154–159.
    1. Hui KKS, Liu J, Marina O, et al. The integrated response of the human cerebro-cerebellar and limbic systems to acupuncture stimulation at ST 36 as evidenced by fMRI. NeuroImage. 2005;27(3):479–496.
    1. Zhao ZQ. Neural mechanism underlying acupuncture analgesia. Progress in Neurobiology. 2008;85(4):355–375.
    1. Romita VV, Suk A, Henry JL. Parametric studies on electroacupuncture-like stimulation in a rat model: effects of intensity, frequency, and duration of stimulation on evoked antinociception. Brain Research Bulletin. 1997;42(4):289–296.
    1. Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965;150(3699):971–979.
    1. Pyne D, Shenker NG. Demystifying acupuncture. Rheumatology. 2008;47(8):1132–1136.
    1. Wang SM, Kain ZN, White P. Acupuncture analgesia: I. The scientific basis. Anesthesia and Analgesia. 2008;106(2):602–610.
    1. Le Bars D, Dickenson AH, Besson JM. Diffuse noxious inhibitory controls (DNIC). II. Lack of effect on non-convergent neurones, supraspinal involvement and theoretical implications. Pain. 1979;6(3):305–327.
    1. Tingåker BK. Changes in human uterine innervation in term pregnancy and labor : occurence and roles of neurotrophins and TRPV1. Stockholm, Sweden: Karolinska Institutet; 2008. Dissertation.
    1. Lowe NK. The nature of labor pain. American Journal of Obstetrics and Gynecology. 2002;186(5, supplement):S16–S24.
    1. Chapman CR, Tuckett RP, Song CW. Pain and stress in a systems perspective: reciprocal neural, endocrine, and immune interactions. Journal of Pain. 2008;9(2):122–145.
    1. Wieseler-Frank J, Maier SF, Watkins LR. Immune-to-brain communication dynamically modulates pain: physiological and pathological consequences. Brain, Behavior, and Immunity. 2005;19(2):104–111.
    1. Altemus M, Rao B, Dhabhar FS, Ding W, Granstein RD. Stress-induced changes in skin barrier function in healthy women. Journal of Investigative Dermatology. 2001;117(2):309–317.
    1. White A, Cummings M. Does acupuncture relieve pain? BMJ. 2009;338(7690):303–304.
    1. Birch S. A review and analysis of placebo treatments, placebo effects, and placebo controls in trials of medical procedures when sham is not inert. Journal of Alternative and Complementary Medicine. 2006;12(3):303–310.
    1. Lundeberg T, Lund I, Näslund J, Thomas M. The Emperor’s sham—wrong assumption that sham needling is sham. Acupuncture in Medicine. 2008;26(4):239–242.
    1. Linde K, Niemann K, Meissner K. Are sham acupuncture interventions more effective than (other) placebos? A re-analysis of data from the cochrane review on placebo effects. Forschende Komplementarmedizin. 2010;17(5):259–264.
    1. Greene CS, Goddard G, Macaluso GM, Mauro G. Topical review: placebo responses and therapeutic responses. How are they related? Journal of Orofacial Pain. 2009;23(2):93–107.
    1. Schytt E, Green JM, Baston HA, Waldenstrom U. A comparison of Swedish and English primiparae’s experiences of birth. Journal of Reproductive and Infant Psychology. 2008;26(4):277–294.
    1. Experience of pregnancy and delivery—the women's perspective. .
    1. Waldenström U. Women’s memory of childbirth at two months and one year after the birth. Birth. 2003;30(4):248–254.
    1. Wickberg B, Hwang CP. The Edinburgh Postnatal Depression Scale: validation on a Swedish community sample. Acta Psychiatrica Scandinavica. 1996;94(3):181–184.
    1. Murray L, Carothers AD. The validation of the Edinburgh Post-natal Depression Scale on a community sample. British Journal of Psychiatry. 1990;157:288–290.
    1. Huskisson E. Visual analogue scales. In: Melzack R, editor. Pain Measurement and Assesment. Vol. 293. New York, NY, USA: Raven; 1983.
    1. Choiniere M, Melzack R, Girard N, Rondeau J, Paquin MJ. Comparisons between patients’ and nurses’ assessment of pain and medication efficacy in severe burn injuries. Pain. 1990;40(2):143–152.
    1. Joyce CRB, Zutshi DW, Hrubes V, Mason RM. Comparison of fixed interval and visual analogue scales for rating chronic pain. European Journal of Clinical Pharmacology. 1975;8(6):415–420.
    1. Hattan J, King L, Griffiths P. The impact of foot massage and guided relaxation following cardiac surgery: a randomized controlled trial. Journal of Advanced Nursing. 2002;37(2):199–207.
    1. Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986;27(1):117–126.
    1. Barclay-Goddard R, Epstein JD, Mayo NE. Response shift: a brief overview and proposed research priorities. Quality of Life Research. 2009;18(3):335–346.
    1. Green JM, Baston HA. Feeling in control during labor: concepts, correlates, and consequences. Birth. 2003;30(4):235–247.
    1. Hildingsson IM. New parents’ experiences of postnatal care in Sweden. Women and Birth. 2007;20(3):105–113.
    1. Waldenström U, Schytt E. A longitudinal study of women’s memory of labour pain—from 2 months to 5 years after the birth. BJOG: An International Journal of Obstetrics and Gynaecology. 2009;116(4):577–583.
    1. Gueorguieva R, Krystal JH. Move over ANOVA: progress in analyzing repeated-measures data and its reflection in papers published in the archives of general psychiatry. Archives of General Psychiatry. 2004;61(3):310–317.
    1. Brown H, Prescott R. Applied Mixed Models in Medicine. New York, NY, USA: Oxford University Press; 1999.

Source: PubMed

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