Effectiveness and Safety of Pharmacopuncture Therapy for Chronic Low Back Pain: A Protocol for a Pragmatic Randomized Controlled Trial

Kyoung Sun Park, Suna Kim, Ji Yeon Seo, HyunWoo Cho, Jee Young Lee, Yoon Jae Lee, Jinho Lee, Min Ji Kim, Young Eun Choi, Chang Sop Yang, Chang-Hyun Han, In-Hyuk Ha, Kyoung Sun Park, Suna Kim, Ji Yeon Seo, HyunWoo Cho, Jee Young Lee, Yoon Jae Lee, Jinho Lee, Min Ji Kim, Young Eun Choi, Chang Sop Yang, Chang-Hyun Han, In-Hyuk Ha

Abstract

Purpose: Chronic low back pain (LBP) is a common musculoskeletal disorder that affects everyday life; moreover, it occasionally causes disability and increases medical expenditure. This pragmatic randomized clinical trial aims to investigate the effects of pharmacopuncture on chronic LBP by comparing the effectiveness of pharmacopuncture and physiotherapy strategies.

Patients and methods: In this two-armed, parallel, multi-center randomized controlled study, the participants will randomly undergo 10 sessions of pharmacopuncture therapy or physiotherapy over five weeks based on the randomization outcomes. The primary outcome will be the numeric rating scale (NRS) score of LBP. The secondary outcomes will include the NRS score of radiating leg pain, visual analog scale (VAS) score of LBP and radiating leg pain, Oswestry disability index, the Korean version of the Roland-Morris disability questionnaire, patient global impression of change (PGIC), short Form-12 health survey version 2, and 5-level EuroQol-5 dimension (EQ-5D-5L).

Conclusion: This protocol aims to examine the comparative effectiveness of pharmacopuncture, which is a widely used therapy in Korean medicine, with respect to the standard therapy through a pragmatic randomized controlled trial to present useful data to facilitate clinical or policy decision making.

Trial registration: Clinicaltrials.gov (NCT04833309); Clinical Research Information Service (KCT0006088).

Keywords: Korean medicine; low back pain; musculoskeletal disorder; pharmacopuncture; physical therapy; pragmatic randomized controlled trial; protocol.

Conflict of interest statement

The authors report no conflicts of interest in this work.

© 2022 Park et al.

References

    1. Centers for Disease Control and Prevention. Prevention. Prevalence of disabilities and associated health conditions among adults–United States, 1999. Morbidity Mortality Weekly Rep. 2001;50(7):120–125.
    1. Dugan S. The role of exercise in the prevention and management of acute low back pain. Clin Occupational Environ Med. 2006;5(3):615–632. doi:10.1016/j.coem.2006.03.003
    1. Krismer M, van Tulder M. Low back pain (non-specific). Best Practice. 2007;21(1):77–91. doi:10.1016/j.berh.2006.08.004
    1. Strudwick MW, Hinks RC, Choy SB. Point injection as an alternative acupuncture technique–an exploratory study of responses in healthy subjects. Acupuncture Med. 2007;25(4):166–174. doi:10.1136/aim.25.4.166
    1. Luna SP, Angeli AL, Ferreira CL, Lettry V, Scognamillo-Szabo M. Comparison of pharmacopuncture, aquapuncture and acepromazine for sedation of horses. Evidence Based Complement Alter Med. 2008;5(3):267–272. doi:10.1093/ecam/nel096
    1. Kwon K. Pharmacopuncturology: Principles and Clinical Applications. Elsevier Korea LLC; 2012.
    1. Acupuncture K. The acupuncture and moxibustion medicine. Seoul. 2012;193:549.
    1. Shin YS, Shin J-S, Lee J, et al. A survey among Korea Medicine doctors (KMDs) in Korea on patterns of integrative Korean Medicine practice for lumbar intervertebral disc displacement: preliminary research for clinical practice guidelines. BMC Complement Altern Med. 2015;15(1):432. doi:10.1186/s12906-015-0956-1
    1. Shin B-C, Kong JC, Park T-Y, Yang C-Y, Kang K-W, Choi S. Bee venom acupuncture for chronic low back pain: a randomised, sham-controlled, triple-blind clinical trial. Eur J Integrative Med. 2012;4(3):e271–e280.
    1. Seo B-K, Han K, Kwon O, Jo D-J, Lee J-HJT. Efficacy of bee venom acupuncture for chronic low back pain: a randomized, double-blinded, sham-controlled trial. Toxins. 2017;9(11):361.
    1. Lee YJ, Shin J-S, Lee J, et al. Usage report of pharmacopuncture in musculoskeletal patients visiting Korean medicine hospitals and clinics in Korea. BMC Complement Altern Med. 2016;16(1):292. doi:10.1186/s12906-016-1288-5
    1. Ahn Y-J, Shin J-S, Lee J, et al. Evaluation of use and cost of medical care of common lumbar disorders in Korea: cross-sectional study of Korean Health Insurance Review and Assessment Service National Patient Sample data. BMJ open. 2016;6(9):e012432. doi:10.1136/bmjopen-2016-012432
    1. Fairbank J, Couper J, Davies JB, O’Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980;66(8):271–273.
    1. Kim D-Y, Lee S-H, Lee H-Y, et al. Validation of the Korean version of the Oswestry disability index. Spine. 2005;30(5):E123–E127. doi:10.1097/01.brs.0000157172.00635.3a
    1. Roland M, Morris R. A study of the natural history of back pain: part 1: development of a reliable and sensitive measure of disability in low-back pain. Spine. 1983;1:548.
    1. Lee JS, Lee DH, Suh KT, Kim JI, Lim JM, Goh TS. Validation of the Korean version of the Roland–Morris disability questionnaire. Eur Spine J. 2011;20(12):2115–2119. doi:10.1007/s00586-011-1788-4
    1. Farrar JT, Young JJP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149–158. doi:10.1016/S0304-3959(01)00349-9
    1. Kim S-H, Jo M-W, Ahn J, Ock M, Shin S, Park J. Assessment of psychometric properties of the Korean SF-12 v2 in the general population. BMC Public Health. 2014;14(1):1086. doi:10.1186/1471-2458-14-1086
    1. Herdman M, Gudex C, Lloyd A, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Quality Life Res. 2011;20(10):1727–1736. doi:10.1007/s11136-011-9903-x
    1. Kim S-H, Ahn J, Ock M, et al. The EQ-5D-5L valuation study in Korea. Quality Life Res. 2016;25(7):1845–1852. doi:10.1007/s11136-015-1205-2
    1. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993;4(5):353–365. doi:10.2165/00019053-199304050-00006
    1. Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007;60(12):1234–1238. doi:10.1016/j.jclinepi.2007.02.006
    1. Ostelo RW, Deyo RA, Stratford P, et al. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine. 2008;33(1):90–94. doi:10.1097/BRS.0b013e31815e3a10
    1. Lauridsen HH, Hartvigsen J, Manniche C, Korsholm L, Grunnet-Nilsson N. Responsiveness and minimal clinically important difference for pain and disability instruments in low back pain patients. BMC. 2006;7(1):1–16.
    1. Ford I, Norrie J. Pragmatic trials. N Eng J Med. 2016;375(5):454–463. doi:10.1056/NEJMra1510059
    1. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967;20(8):637–648. doi:10.1016/0021-9681(67)90041-0
    1. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Clin Epidemiol. 2009;62(5):499–505. doi:10.1016/j.jclinepi.2009.01.012
    1. Thorpe KE, Zwarenstein M, Oxman AD, et al. A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 2009;62(5):464–475. doi:10.1016/j.jclinepi.2008.12.011
    1. Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015;350:h2147. doi:10.1136/bmj.h2147

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe