Effects of electroacupuncture frequencies on chronic low back pain in older adults: triple-blind, 12-months protocol for a randomized controlled trial

Sarina Francescato Torres, Ana Carolina Brandt de Macedo, Mateus Dias Antunes, Ingred Merllin Batista de Souza, Francisco Dimitre Rodrigo Pereira Santos, Adriana de Sousa do Espírito Santo, Flávia Ribeiro Jacob, Ariela Torres Cruz, Priscila de Oliveira Januário, Amélia Pasqual Marques, Sarina Francescato Torres, Ana Carolina Brandt de Macedo, Mateus Dias Antunes, Ingred Merllin Batista de Souza, Francisco Dimitre Rodrigo Pereira Santos, Adriana de Sousa do Espírito Santo, Flávia Ribeiro Jacob, Ariela Torres Cruz, Priscila de Oliveira Januário, Amélia Pasqual Marques

Abstract

Background: Low back pain (LBP) is the most frequent complaint in clinical practice. Electroacupuncture treatment may be effective; however, the supporting evidence is still limited, especially in older adults.

Objective: The current study is a randomized controlled trial that aims to evaluate the clinical efficacy of electroacupuncture in older adults with LBP.

Methods: A five-arm randomized controlled trial with patients and evaluators blinded to the group allocation. A total of 125 participants with non-specific LBP will be randomly assigned into one of five groups: three electroacupuncture groups (low, high, and alternating frequency); one control group; and one placebo group. The electroacupuncture will be applied twice a week (30 min per session) for five weeks. The primary clinical outcome measure will be pain intensity. The secondary outcomes include: quality of pain; physical functioning; perceived overall effect; emotional functionality; patient satisfaction; and psychosocial factors. Patients will be evaluated before the first session, immediately after the last, and followed up after six and 12 months to check the medium- and long-term effects.

Discussion: Although electroacupuncture is increasingly used to treat LBP, there is no guidance regarding the parameters used, which leads to inconsistent results. Thus, the effect of electroacupuncture (EA) on LBP remains controversial and requires more studies, especially in the older adult population.

Conclusion: This is the first randomized controlled trial to evaluate the efficacy of different frequencies of electroacupuncture for treating chronic LBP in older adults. This study will provide evidence on the effectiveness of electroacupuncture as an alternative treatment method for LBP and will entail wider debate about an appropriate acupuncture intervention in this population.

Trial registration: Clinicaltrials.gov, NCT03802045. Registered on 14 January 2019.

Keywords: Acupuncture; Aged; Clinical trial; Electroacupuncture; Low back pain.

Conflict of interest statement

All authors deny any financial and personal relationships with other people or organizations that could inappropriately influence this work.

Figures

Fig. 1
Fig. 1
Study timepoints
Fig. 2
Fig. 2
Flow chart of study design

References

    1. Malta DC, Oliveira MM, Andrade S, Caiaffa WT, Souza MFM, Bernal RTI. Factors associated with chronic back pain in adults in Brazil. Rev Saude Publica. 2017;51:9s.
    1. Wong AYL, Forss KS, Jakobsson J, Schoeb V, Kumlien C, Borglin G. Older adult’s experience of chronic low back pain and its implications on their daily life: Study protocol of a systematic review of qualitative research. Syst Rev. 2018;7:81. doi: 10.1186/s13643-018-0742-5.
    1. Wong AY, Karppinen J, Samartzis D. Low back pain in older adults: risk factors, management options and future directions. Scoliosis Spinal Disord. 2017;12:14. doi: 10.1186/s13013-017-0121-3.
    1. Lardon A, Dubois JD, Cantin V, Piche M, Descarreaux M. Predictors of disability and absenteeism in workers with non-specific low back pain: A longitudinal 15-month study. Appl Ergon. 2018;68:176–185. doi: 10.1016/j.apergo.2017.11.011.
    1. Fang JF, Du JY, Shao XM, Fang JQ, Liu Z. Effect of Electroacupuncture on the NTS is modulated primarily by acupuncture point selection and stimulation frequency in normal rats. BMC Complement Altern Med. 2017;17:182. doi: 10.1186/s12906-017-1690-7.
    1. Langevin HM, Schnyer R, MacPherson H, Davis R, Harris RE, Napadow V, et al. Manual and electrical needle stimulation in acupuncture research: pitfalls and challenges of heterogeneity. J Altern Complement Med. 2015;21:113–128. doi: 10.1089/acm.2014.0186.
    1. Comachio J, Oliveira Magalhaes M, Nogueira Burke T, Vidal Ramos LA, Peixoto Leao Almeida G, Silva AP, Ferreira de Meneses SR, Costa-Frutuoso JR, Santos Miotto Amorim C, Pasqual Marques A. Efficacy of acupuncture and electroacupuncture in patients with nonspecific low back pain: study protocol for a randomized controlled trial. Trials. 2015;16:469. doi: 10.1186/s13063-015-0850-7.
    1. Hong Z, Bao-yan L, Zhi-shun L, Li-min X, Vi-gong F, Yuan Z, et al. Clinical practice guidelines of using acupuncture for low back pain. World J Acupunct Moxibustion. 2016;26:1–13.
    1. Beard JR, Officer AM, Cassels AK. The World Report on Ageing and Health. Gerontologist. 2016;56(Suppl 2):S163–S166. doi: 10.1093/geront/gnw037.
    1. de Carvalho RC, Parisi JR, Prado WA, de Araujo JE, Silva AM, Silva JRT, et al. Single or Multiple Electroacupuncture Sessions in Nonspecific Low Back Pain: Are We Low-Responders to Electroacupuncture? J Acupunct Meridian Stud. 2018;11:54–61. doi: 10.1016/j.jams.2018.02.002.
    1. Leite Paula M. S., Mendonça Andreza R. C., Maciel Leonardo Y. S., Poderoso-Neto Maurício L., Araujo Carla C. A., Góis Hilda C. J., Souza Jérsica H. S., DeSantana Josimari M. Does Electroacupuncture Treatment Reduce Pain and Change Quantitative Sensory Testing Responses in Patients with Chronic Nonspecific Low Back Pain? A Randomized Controlled Clinical Trial. Evidence-Based Complementary and Alternative Medicine. 2018;2018:1–8. doi: 10.1155/2018/8586746.
    1. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113:9–19. doi: 10.1016/j.pain.2004.09.012.
    1. 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;34:203–210. doi: 10.1590/S0100-879X2001000200007.
    1. Gomes-Oliveira MH, Gorenstein C, Lotufo Neto F, Andrade LH, Wang YP. Validation of the Brazilian Portuguese version of the Beck Depression Inventory-II in a community sample. Braz J Psychiatry. 2012;34:389–394. doi: 10.1016/j.rbp.2012.03.005.
    1. de Fatima Costa Oliveira N, Oliveira Pena Costa L, Nelson R, Maher CG, Beattie PF, de Bie R, et al. Measurement properties of the Brazilian Portuguese version of the MedRisk instrument for measuring patient satisfaction with physical therapy care. J Orthop Sports Phys Ther. 2014;44:879–889. doi: 10.2519/jospt.2014.5150.
    1. Pilz B, Vasconcelos RA, Marcondes FB, Lodovichi SS, Mello W, Grossi DB. The Brazilian version of STarT Back Screening Tool - translation, cross-cultural adaptation and reliability. Braz J Phys Ther. 2014;18:453–461. doi: 10.1590/bjpt-rbf.2014.0028.
    1. 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;33:2459–2463. doi: 10.1097/BRS.0b013e3181849dbe.
    1. Correa JB, Costa LO, de Oliveira NT, Sluka KA, Liebano RE. Effects of the carrier frequency of interferential current on pain modulation in patients with chronic nonspecific low back pain: a protocol of a randomised controlled trial. BMC Musculoskelet Disord. 2013;14:195. doi: 10.1186/1471-2474-14-195.
    1. Varoli FK, Pedrazzi V. Adapted version of the McGill Pain Questionnaire to Brazilian Portuguese. Braz Dent J. 2006;17:328–335. doi: 10.1590/S0103-64402006000400012.
    1. Menezes Costa Lda C, Maher CG, McAuley JH, Hancock MJ, de Melo OW, 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;64:903–912. doi: 10.1016/j.jclinepi.2010.12.009.
    1. Kahraman T, Ozcan Kahraman B, Salik Sengul Y, Kalemci O. Assessment of sit-to-stand movement in nonspecific low back pain: a comparison study for psychometric properties of field-based and laboratory-based methods. Int J Rehabil Res. 2016;39:165–170. doi: 10.1097/MRR.0000000000000164.
    1. Gorenstein C, Andrade L, Vieira Filho AH, Tung TC, Artes R. Psychometric properties of the Portuguese version of the Beck Depression Inventory on Brazilian college students. J Clin Psychol. 1999;55:553–562. doi: 10.1002/(SICI)1097-4679(199905)55:5<553::AID-JCLP3>;2-D.
    1. Williams VS, Morlock RJ, Feltner D. Psychometric evaluation of a visual analog scale for the assessment of anxiety. Health Qual Life Outcomes. 2010;8:57. doi: 10.1186/1477-7525-8-57.
    1. Lim S. WHO Standard Acupuncture Point Locations. Evid Based Complement Alternat Med. 2010;7:167–168. doi: 10.1093/ecam/nep006.
    1. Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, et al. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med. 2009;169:858–866. doi: 10.1001/archinternmed.2009.65.
    1. Liu L, Skinner MA, McDonough SM, Baxter GD. Acupuncture for chronic low back pain: a randomized controlled feasibility trial comparing treatment session numbers. Clin Rehabil. 2017;31:1592–1603. doi: 10.1177/0269215517705690.
    1. Rached RDVA, Rosa CDP, Alfieri FM, Amaro SMC, Nogueira B, Dotta L, et al. Chronic nonspecific low back pain: rehabilitation. Revista da Associação Médica Brasileira. 2013;59:536–553.
    1. Schliessbach J, Nielsen LA, Klift EVD, Curatolo M, Streitberger K. The effect of brief electrical and manual acupuncture stimulation on mechanical experimental pain. Pain Med. 2011;12:268–275. doi: 10.1111/j.1526-4637.2010.01051.x.
    1. Feijó AGS, Crippa A, Giordani AD, Vieira NM, Filho CI. Clinical research from the perspective of integrity. Revista Bioética. 2018;26:172–182. doi: 10.1590/1983-80422018262237.
    1. Corrêa J, Costa L, Oliveira N, Lima W, Sluka K, Liebano R. Effects of the carrier frequency of interferential current on pain modulation and central hypersensitivity in people with chronic nonspecific low back pain: A randomized placebo-controlled trial. Eur J Pain. 2016;20:1653–1666. doi: 10.1002/ejp.889.
    1. Q-l Y, Wang P, Liu L, Sun F, Cai Y-S, Wu W-T, et al. Acupuncture for musculoskeletal pain: A meta-analysis and metaregression of sham-controlled randomized clinical trials. Sci Rep. 2016;6:1–24. doi: 10.1038/s41598-016-0001-8.
    1. Oliveira CB, Maher CG, Pinto RZ, Traege AC, Lin CWC, Chenot JF, et al. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018;27:2791–2803. doi: 10.1007/s00586-018-5673-2.
    1. Yin C, Buchheit TE, Park JJ. Acupuncture for chronic pain: an update and critical overview. Pain Med. 2017;30:583–592.
    1. Chen L, Michalsen A. Management of chronic pain using complementary and integrative medicine. BMJ. 2017;357:1–19.
    1. Yeganeh M, Baradaran HR, Ghorbani M, Moradi Y, Dastgiri S. The effectiveness of acupuncture, acupressure and chiropractic interventions on treatment of chronic nonspecific low back pain in Iran: A systematic review and metaanalysis. Complement Ther Clin Pract. 2017;27:11–18. doi: 10.1016/j.ctcp.2016.11.012.

Source: PubMed

3
Prenumerera