Auricular acupuncture for primary care treatment of low back pain and posterior pelvic pain in pregnancy: study protocol for a multicentre randomised placebo-controlled trial

Jorge Vas, José Manuel Aranda-Regules, Manuela Modesto, Inmaculada Aguilar, Mercedes Barón-Crespo, María Ramos-Monserrat, Manuel Quevedo-Carrasco, Francisco Rivas-Ruiz, Jorge Vas, José Manuel Aranda-Regules, Manuela Modesto, Inmaculada Aguilar, Mercedes Barón-Crespo, María Ramos-Monserrat, Manuel Quevedo-Carrasco, Francisco Rivas-Ruiz

Abstract

Background: About 45% of all pregnant women suffer low back pain and/or pelvic girdle pain (LBPGP). This study seeks to evaluate the effect of auricular acupuncture on LBPGP compared with placebo auricular acupuncture and with standard obstetric care in the field of primary health care.

Methods and design: This study will be a four-parallel-arm, multicentre, randomised, placebo-controlled trial. A total of 212 pregnant women (24 to 36 weeks' gestation), aged at least 17 years, with LBPGP, will be randomly assigned to the verum auricular acupuncture plus standard obstetric care group (VAAc), to the non-specific auricular acupuncture plus standard obstetric care group (NSAAc), to the non-specific placebo auricular acupuncture plus standard obstetric care group (PAAc), or the standard obstetric care group (SOC). The VAAc, NSAAc, and PAAc groups will receive treatment at three auricular acupuncture points (specific points for the VAAc group or non-specific ones for the NSAAc and PAAc groups), once a week for 2 weeks; the SOC group will receive only standard obstetric care during the same period. The primary outcome will be the reduction in pain intensity, according to the visual analogue scale (iVAS), at 2 weeks after the start of treatment. The secondary outcomes will be functional status with respect to LBPGP (according to the Roland-Morris disability questionnaire), health-related quality of life (SF12) at 2 weeks after the start of treatment, and iVAS at 12 and 48 weeks postpartum.

Discussion: This trial will implement a high-quality methodology and may provide evidence for the efficacy, safety, and specificity of auricular acupuncture as a treatment for pregnant women with LBPGP.

Trial registration: Current Controlled Trials ISRCTN41033073 (date 20/03/2014).

Figures

Figure 1
Figure 1
Trial flow.
Figure 2
Figure 2
Auricular device used for the verum auricular acupuncture and non-specific auricular acupuncture (New Pyonex) groups and for the placebo auricular acupuncture group.
Figure 3
Figure 3
Specific and non-specific auricular acupuncture points used for the different study groups.

References

    1. Noren L, Ostgaard S, Johansson G, Ostgaard HC. Lumbar back and posterior pelvic pain during pregnancy: a 3-year follow-up. Eur Spine J. 2002;11(3):267–271. doi: 10.1007/s00586-001-0357-7.
    1. Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008;17(6):794–819. doi: 10.1007/s00586-008-0602-4.
    1. Ostgaard HC, Zetherstrom G, Roos-Hansson E, Svanberg B. Reduction of back and posterior pelvic pain in pregnancy. Spine (Phila Pa 1976) 1994;19(8):894–900. doi: 10.1097/00007632-199404150-00005.
    1. Bastiaanssen JM, de Bie RA, Bastiaenen CH, Essed GG, van den Brandt PA. A historical perspective on pregnancy-related low back and/or pelvic girdle pain. Eur J Obstet Gynecol Reprod Biol. 2005;120(1):3–14. doi: 10.1016/j.ejogrb.2004.11.021.
    1. MacLennan AH, Nicolson R, Green RC, Bath M. Serum relaxin and pelvic pain of pregnancy. Lancet. 1986;2(8501):243–245.
    1. Bewyer KJ, Bewyer DC, Messenger D, Kennedy CM. Pilot data: association between gluteus medius weakness and low back pain during pregnancy. Iowa Orthop J. 2009;29:97–99.
    1. Mogren IM. Previous physical activity decreases the risk of low back pain and pelvic pain during pregnancy. Scand J Public Health. 2005;33(4):300–306. doi: 10.1177/140349480503300410.
    1. Wu WH, Meijer OG, Uegaki K, Mens JM, van Dieen JH, Wuisman PI, Ostgaard HC. Pregnancy-related pelvic girdle pain (PPP), I: Terminology, clinical presentation, and prevalence. Eur Spine J. 2004;13(7):575–589. doi: 10.1007/s00586-003-0615-y.
    1. Malmqvist S, Kjaermann I, Andersen K, Ekland I, Bronnick K, Larsen JP. Prevalence of low back and pelvic pain during pregnancy in a Norwegian population. J Manip Physiol Ther. 2012;35(4):272–278. doi: 10.1016/j.jmpt.2012.04.004.
    1. Kovacs FM, Garcia E, Royuela A, Gonzalez L, Abraira V. Prevalence and factors associated with low back pain and pelvic girdle pain during pregnancy: a multicenter study conducted in the Spanish National Health Service. Spine (Phila Pa 1976) 2012;37(17):1516–1533. doi: 10.1097/BRS.0b013e31824dcb74.
    1. Russell R, Dundas R, Reynolds F. Long term backache after childbirth: prospective search for causative factors. BMJ. 1996;312(7043):1384–1388. doi: 10.1136/bmj.312.7043.1384a.
    1. Lile J, Perkins J, Hammer RL, Loubert PV. Diagnostic and management strategies for pregnant women with back pain. JAAPA. 2003;16(12):31–39.
    1. Robinson HS, Eskild A, Heiberg E, Eberhard-Gran M. Pelvic girdle pain in pregnancy: the impact on function. Acta Obstet Gynecol Scand. 2006;85(2):160–164. doi: 10.1080/00016340500410024.
    1. Olsson C, Nilsson-Wikmar L. Health-related quality of life and physical ability among pregnant women with and without back pain in late pregnancy. Acta Obstet Gynecol Scand. 2004;83(4):351–357. doi: 10.1080/j.0001-6349.2004.00384.x.
    1. van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, Koes B, Laerum E, Malmivaara A. Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J. 2006;15(2):S169–S191.
    1. Deyo RA, Battie M, Beurskens AJ, Bombardier C, Croft P, Koes B, Malmivaara A, Roland M, von Korff M, Waddell G. Outcome measures for low back pain research. A proposal for standardized use. Spine. 1998;23(18):2003–2013. doi: 10.1097/00007632-199809150-00018.
    1. Ostgaard HC, Zetherstrom G, Roos-Hansson E. Back pain in relation to pregnancy: a 6-year follow-up. Spine (Phila Pa 1976) 1997;22(24):2945–2950. doi: 10.1097/00007632-199712150-00018.
    1. Vermani E, Mittal R, Weeks A. Pelvic girdle pain and low back pain in pregnancy: a review. Pain Pract. 2010;10(1):60–71. doi: 10.1111/j.1533-2500.2009.00327.x.
    1. van Gelder MM, Roeleveld N, Nordeng H. Exposure to non-steroidal anti-inflammatory drugs during pregnancy and the risk of selected birth defects: a prospective cohort study. PLoS One. 2011;6(7):e22174. doi: 10.1371/journal.pone.0022174.
    1. Antonucci R, Zaffanello M, Puxeddu E, Porcella A, Cuzzolin L, Pilloni MD, Fanos V. Use of non-steroidal anti-inflammatory drugs in pregnancy: impact on the fetus and newborn. Curr Drug Metab. 2012;13(4):474–490. doi: 10.2174/138920012800166607.
    1. Brennan MC, Rayburn WF. Counseling about risks of congenital anomalies from prescription opioids. Birth Defects Res A Clin Mol Teratol. 2012;94(8):620–625. doi: 10.1002/bdra.23064.
    1. Pennick VE, Young G. Interventions for preventing and treating pelvic and back pain in pregnancy. Cochrane Database Syst Rev. 2007;2 CD001139.
    1. Ee CC, Manheimer E, Pirotta MV, White AR. Acupuncture for pelvic and back pain in pregnancy: a systematic review. Am J Obstet Gynecol. 2008;198(3):254–259. doi: 10.1016/j.ajog.2007.11.008.
    1. Wedenberg K, Moen B, Norling A. A prospective randomized study comparing acupuncture with physiotherapy for low-back and pelvic pain in pregnancy. Acta Obstet Gynecol Scand. 2000;79(5):331–335. doi: 10.1080/j.1600-0412.2000.079005331.x.
    1. Kvorning N, Holmberg C, Grennert L, Aberg A, Akeson J. Acupuncture relieves pelvic and low-back pain in late pregnancy. Acta Obstet Gynecol Scand. 2004;83(3):246–250. doi: 10.1080/j.0001-6349.2004.0215.x.
    1. Ekdahl L, Petersson K. Acupuncture treatment of pregnant women with low back and pelvic pain - an intervention study. Scand J Caring Sci. 2010;24(1):175–182. doi: 10.1111/j.1471-6712.2009.00704.x.
    1. Wang SM, DeZinno P, Fermo L, William K, Caldwell-Andrews AA, Bravemen F, Kain ZN. Complementary and alternative medicine for low-back pain in pregnancy: a cross-sectional survey. J Altern Complement Med. 2005;11(3):459–464. doi: 10.1089/acm.2005.11.459.
    1. Stux G, Pomeranz B. Fundamentos de Acupuntura. 4. Barcelona: Masson; 2000.
    1. Sandkuhler J. Learning and memory in pain pathways. Pain. 2000;88(2):113–118. doi: 10.1016/S0304-3959(00)00424-3.
    1. Sator-Katzenschlager SM, Scharbert G, Kozek-Langenecker SA, Szeles JC, Finster G, Schiesser AW, Heinze G, Kress HG. The short- and long-term benefit in chronic low back pain through adjuvant electrical versus manual auricular acupuncture. Anesth Analg. 2004;98(5):1359–1364.
    1. Wang SM, DeZinno P, Lin EC, Lin H, Yue JJ, Berman MR, Braveman F, Kain ZN. Auricular acupuncture as a treatment for pregnant women who have low back and posterior pelvic pain: a pilot study. Am J Obstet Gynecol. 2009;201(3):271.
    1. Vas J, Aranda-Regules JM, Modesto M, Ramos-Monserrat M, Baron M, Aguilar I, Benitez-Parejo N, Ramirez-Carmona C, Rivas-Ruiz F. Using moxibustion in primary healthcare to correct non-vertex presentation: a multicentre randomised controlled trial. Acupunct Med. 2013;31(1):31–38. doi: 10.1136/acupmed-2012-010261.
    1. Oleson T. Auriculotherapy Manual. Los Angeles: Health Care Alternatives, Inc.; 1998.
    1. Miyazaki S, Hagihara A, Kanda R, Mukaino Y, Nobutomo K. Applicability of press needles to a double-blind trial: a randomized, double-blind, placebo-controlled trial. Clin J Pain. 2009;25(5):438–444. doi: 10.1097/AJP.0b013e318193a6e1.
    1. von Korff M, Jensen MP, Karoly P. Assessing global pain severity by self-report in clinical and health services research. Spine. 2000;25(24):3140–3151. doi: 10.1097/00007632-200012150-00009.
    1. Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983;16(1):87–101. doi: 10.1016/0304-3959(83)90088-X.
    1. Revill SI, Robinson JO, Rosen M, Hogg MI. The reliability of a linear analogue for evaluating pain. Anaesthesia. 1976;31(9):1191–1198. doi: 10.1111/j.1365-2044.1976.tb11971.x.
    1. Ostelo RWJG, de Vet HCW. Clinically important outcomes in low back pain. Best Pract Res Clin Rheumatol. 2005;19(4):593–607. doi: 10.1016/j.berh.2005.03.003.
    1. Kovacs FM, Llobera J, del Real MTG, Abraira V, Gestoso M, Fernandez C. Primaria Group. Validation of the spanish version of the Roland-Morris questionnaire. Spine. 2002;27(5):538–542. doi: 10.1097/00007632-200203010-00016.
    1. Monton C, Perez Echeverria MJ, Campos R, Garcia CJ, Lobo A. Anxiety scales and Goldberg’s depression: an efficient interview guide for the detection of psychologic distress. Aten Primaria. 1993;12(6):345–349.
    1. Bombardier C, Esmail R, Nachemson AL. The Cochrane Collaboration Back Review Group for spinal disorders. Spine. 1997;22(8):837–840. doi: 10.1097/00007632-199704150-00001.
    1. Hudak PL, Wright JG. The characteristics of patient satisfaction measures. Spine. 2000;25(24):3167–3177. doi: 10.1097/00007632-200012150-00012.
    1. Vincent C, Lewith G. Placebo controls for acupuncture studies. J R Soc Med. 1995;88(4):199–202.
    1. Borkovec TD, Nau SD. Credibility of analogue therapy rationales. J Beh Ther Exp Pschiat. 1972;3(4):257–260. doi: 10.1016/0005-7916(72)90045-6.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren