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Open Access 01-12-2015 | Study protocol

Efficacy of acupuncture and electroacupuncture in patients with nonspecific low back pain: study protocol for a randomized controlled trial

Authors: Josielli Comachio, Mauricio Oliveira Magalhães, Thomaz Nogueira Burke, Luiz Armando Vidal Ramos, Gabriel Peixoto Leão Almeida, Ana Paula M. C. C. Silva, Sarah Rúbia Ferreira de Meneses, Jecilene Rosana Costa-Frutuoso, Cinthia Santos Miotto Amorim, Amélia Pasqual Marques

Published in: Trials | Issue 1/2015

Abstract

Background

Previous studies have shown that acupuncture and electroacupuncture (EA) are effective in the treatment of patients with low back pain. However, there is little evidence to support the use of one intervention over the other. The aim of this study is to compare the effect of acupuncture and electroacupuncture in the treatment of pain and disability in patients with chronic nonspecific low back pain.

Methods/design

The study design is a randomized controlled trial. Patients with nonspecific chronic low back pain of more than three months duration are recruited at Rehabilitation Center of Taboao da Serra - SP (Brazil). After examination, sixty-six patients will be randomized into one of two groups: acupuncture group (AG) (n = 33) and electroacupuncture group (EG) (n = 33). Interventions will last one hour, and will happen twice a week for 6 weeks. The primary clinical outcomes will be pain intensity as measured and functional disability. Secondary outcomes: quality of pain, quality of life. perception of the overall effect, depressive state, flexibility and kinesiophobia. All the outcomes will be assessed will be assessed at baseline, at treatment end, and three months after treatment end. Significance level will be determined at the 5 % level. Results of this trial will help clarify the value of acupuncture and electroacupuncture as a treatment for chronic low back pain and if they are different.

Discussion

Results of this trial will help clarify the value of acupuncture needling and electroacupuncture stimulation of specific points on the body as a treatment for chronic low back pain.

Trial Registration

Clinicaltrials.gov: NCT02039037. Register October 30, 2013.

Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, et al. Chapter 4 - European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006;15:S192–300. doi:10.1007/s00586-006-1072-1.CrossRefPubMedPubMedCentral

Beck AT, Erbaugh J, Ward CH, Mock J, Mendelsohn M. An inventory for measuring depression. Arch Gen Psychiat. 1961;4(6):561–71.CrossRefPubMed

Chou R, Qaseem A, Snow V, Casey D, Cross Jr JT, Shekelle P, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007;147(7):478–91.CrossRefPubMed

Ciconelli RM, Feraz MB, Santos W. Tradução para a língua portuguesa e validação do questionário genérico de avaliação de qualidade de vida SF-36. Rev Bras Reumatol. 1999;39:143–9.

Costa LO, Maher CG, Latimer J, Ferreira PH, Ferreira ML, Pozzi GC, et al. Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best? Spine (Phila Pa 1976). 2008;33(22):2459–63. doi:10.1097/BRS.0b013e3181849dbe.CrossRef

Costa LOP, Maher CG, Latimer J, Ferreira PH, Pozzi GC, Ribeiro RN. Psychometric characteristics of the Brazilian-Portuguese versions of the functional rating index and the Roland Morris disability questionnaire. Spine. 2007;32(17):1902–7. doi:10.1097/Brs.0b013e31811eab33.CrossRefPubMed

Costa LDM, Maher CG, McAuley JH, Hancock MJ, Herbert RD, Refshauge KM, et al. Prognosis for patients with chronic low back pain: inception cohort study. Brit Med J. 2009;339:Artn B3829. doi:10.1136/Bmj.B3829.

Costa LDM, Maher CG, McAuley JH, Hancock MJ, Oliveira WD, Azevedo DC, et al. The Brazilian-Portuguese versions of the McGill pain questionnaire were reproducible, valid, and responsive in patients with musculoskeletal pain. J Clin Epidemiol. 2011;64(8):903–12. doi:10.1016/j.jclinepi.2010.12.009.CrossRefPubMed

Darlow B, Fullen BM, Dean S, Hurley DA, Baxter GD, Dowell A. The association between health care professional attitudes and beliefs and the attitudes and beliefs, clinical management, and outcomes of patients with low back pain: A systematic review. Eur J Pain. 2012;16(1):3–17. doi:10.1016/j.ejpain.2011.06.006.CrossRefPubMed

10.

Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, et al. Low back pain clinical practice guidelines linked to the international classification of functioning, disability, and health from the orthopaedic section of the American physical therapy association. J Orthop Sport Phys. 2012;42(4):A1–57. doi:10.2519/jospt.2012.0301.CrossRef

11.

George SZ, Fritz JM, Childs JD. Investigation of elevated fear-avoidance beliefs for patients with low back pain: A secondary analysis involving patients enrolled in physical therapy clinical trials. J Orthop Sport Phys. 2008;38(2):50–8. doi:10.2519/jospt.2008.2647.CrossRef

12.

Guideline NC. Early management of persistent non-specific low back pain: A NICE guideline. National Institute for Health and Clinical Excellence. 2009.

13.

Han J. Electroacupuncture: an alternative to antidepressants for treating affective diseases? Inter J Neurosis. 1986;29(1–2):79–92.CrossRef

14.

Hutchinson AJP, Ball S, Andrews JCH, Jones GG. The effectiveness of acupuncture in treating chronic non-specific low back pain: a systematic review of the literature. J Orthop Surg Res. 2012;7:Artn 36. doi:10.1186/1749-799x-7-36.

15.

Kwon Y, Kang M, Son S, Kim J, Lee Y, Han H, et al. Different frequencies of electroacupuncture modified the cellular activity of serotonergic neurons in brainstem. Am J Chin Med. 2000;28:435–41.CrossRefPubMed

16.

Lehmann TR, Russell DW, Spratt KF, Colby H, Liu YK, Fairchild ML, et al. Efficacy of electroacupuncture and tens in the rehabilitation of chronic low-back-pain patients. Pain. 1986;26(3):277–90. doi:10.1016/0304-3959(86)90057-6.CrossRefPubMed

17.

Magnusson SP, Simonsen EB, Aagaard P, Boesen J, Johannsen F, Kjaer M. Determinants of musculoskeletal flexibility: viscoelastic properties, cross-sectional area, EMG and stretch tolerance. Scand J Med Sci Spor. 1997;7(4):195–202.CrossRef

18.

Martins J, Sousa LM, Oliveira AS. Recomendações do enunciado CONSORT para o relato de estudos clínicos controlados e randomizados. Medicina. 2009;42(1):9–21.

19.

Nusbaum L, Natour J, Ferraz MB, Goldenberg J. Translation, adaptation and validation of the Roland-Morris questionnaire - Brazil Roland-Morris. Braz J Med Biol Res. 2001;34(2):203–10.CrossRefPubMed

20.

Pherson HM, Altman DG, Hammerschlag R, Li Youping, Taixiang W, Adrian White et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT Statement. PLoS Medice. 2010;8(6):7.

21.

Rainville J, Smeets RJEM, Bendix T, Tveito TH, Poiraudeau S, Indahl AJ. Fear-avoidance beliefs and pain avoidance in low back pain-translating research into clinical practice. Spine J. 2011;11(9):895–903. doi:10.1016/j.spinee.2011.08.006.CrossRefPubMed

22.

Ratcliffe J, Thomas KJ, MacPherson H. Controlled trial of acupuncture care for persistent low back pain: cost effectiveness analysis. Brit Med J. 2006;333(7569):626.CrossRefPubMedPubMedCentral

23.

Souza FS, Marinho CD, Siqueira FB, Maher CG, Costa LOP. Psychometric testing confirms that the Brazilian-Portuguese adaptations, the original versions of the Fear-Avoidance Beliefs Questionnaire, and the Tampa Scale of Kinesiophobia have similar measurement properties. Spine. 2008;33(9):1028–33. doi:10.1097/Brs.0b013e31811eab33.CrossRefPubMed

24.

Thomas M, Lundberg T. Importance of modes of acupuncture in the treatment of chronic nociceptive Low-back-pain. Acta Anaesth Scand. 1994;38(1):63–9.CrossRefPubMed

25.

Varoli FK, Pedrazzi V. Adapted version of the McGill pain questionnaire to Brazilian Portuguese. Braz Dent J. 2006;17(4):328–35.CrossRefPubMed

26.

Waddell G. The Back Pain Revolution. 2nd ed. Australia: Churchill Livingstone; 2004.

27.

Wang KM, Yao SM, Xian YL, Hou ZL. A study on the receptive-field of acupoints and the relationship between characteristics of needling sensation and groups of afferent-fibers. Sci Sin B-Chem B a M. 1985;28(9):963–77.

28.

Weckowicz WMTE, Cropley AJ. A factor analysis of the beck inventory of depression. J Consult Psychol. 1967;31:23–8.CrossRef

29.

Witt CM, Schutzler L, Ludtke R, Wegscheider K, Willich SN. Pragmatic randomized trial evaluating the clinical and economic effectiveness of acupuncture for chronic low back pain. Epidemiology. 2006;164(5):487–96. doi:10.1097/Ajp.0b013e31820dfbf5.

30.

Witt CM, Schutzler L, Ludtke R, Wegscheider K, Willich SN. Patient characteristics and variation in treatment outcomes which patients benefit most from acupuncture for chronic pain? Clin J Pain. 2011;27(5):550. doi:10.1097/Ajp.0b013e31820dfbf5.CrossRefPubMed

31.

Wong RHL, Lee TW, Sihoe ADL, Wan IYP, Ng CSH, Chan SKC, et al. Analgesic effect of electroacupuncture in postthoracotomy pain: a prospective randomized trial. Ann Thorac Surg. 2006;81(6):2031–6. doi:10.1016/j.athoracsur.2005.12.064.CrossRefPubMed

32.

World Health Organization: Acupuncture: Review and Analysis of Reports on Controlled Clinical Trials. WHO Library Cataloguing-in-Publication Data, Geneva; 2002.

Title: Efficacy of acupuncture and electroacupuncture in patients with nonspecific low back pain: study protocol for a randomized controlled trial
Authors: Josielli Comachio
Mauricio Oliveira Magalhães
Thomaz Nogueira Burke
Luiz Armando Vidal Ramos
Gabriel Peixoto Leão Almeida
Ana Paula M. C. C. Silva
Sarah Rúbia Ferreira de Meneses
Jecilene Rosana Costa-Frutuoso
Cinthia Santos Miotto Amorim
Amélia Pasqual Marques
Publication date: 01-12-2015
Publisher: BioMed Central
Published in: Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-015-0850-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Efficacy of acupuncture and electroacupuncture in patients with nonspecific low back pain: study protocol for a randomized controlled trial

Abstract

Background

Methods/design

Discussion

Trial Registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial Registration

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