Efficacy and safety of treating chronic nonspecific low back pain with radial extracorporeal shock wave therapy (rESWT), rESWT combined with celecoxib and eperisone (C + E) or C + E alone: a prospective, randomized trial

Xuejiao Guo, Lin Li, Zhe Yan, Yunze Li, Zhiyou Peng, Yixin Yang, Yanfeng Zhang, Christoph Schmitz, Zhiying Feng, Xuejiao Guo, Lin Li, Zhe Yan, Yunze Li, Zhiyou Peng, Yixin Yang, Yanfeng Zhang, Christoph Schmitz, Zhiying Feng

Abstract

Background: To investigate whether respectively radial extracoporeal shock wave therapy (rESWT) or a combination of rESWT, celecoxib and eperisone (rESWT + C + E) are superior in reducing pain in patients with chronic nonspecific low back pain (cnsLBP) compared to C + E alone (a standard treatment of this condition in China).

Methods: 140 patients with cnsLBP were randomly allocated to rESWT (n = 47), rESWT + C + E (n = 45) or C + E alone (n = 48) for four weeks between November 2017 and March 2019. Outcome was evaluated using the Pain Self-Efficacy Questionnaire (PSEQ), Numerical Rating Scale (NRS), Oswestry Low Back Pain Disability Questionnaire and Patient Health Questionnaire 9, collected at baseline as well as one week (W1), W2, W3, W4 and W12 after baseline.

Results: All scores showed a statistically significant improvement over time. The PSEQ and NRS scores showed a significant Time × Treatment effect. Patients treated with rESWT had significantly lower mean NRS values than patients treated with rESWT + C + E at W1 and W3, as well as than patients treated with C + E alone at W3 and W4. No severe adverse events were observed.

Conclusions: rESWT may not be inferior to respectively rESWT + C + E or C + E alone in reducing pain in patients with cnsLBP.

Level of evidence: Level I, prospective, randomized, active-controlled trial.

Trial registration: Clinicaltrials.gov Identifier NCT03337607. Registered November 09, 2017, https://www.clinicaltrials.gov/ct2/show/NCT03337607 .

Level of evidence: Level I; prospective, randomized, controlled trial.

Keywords: Celecoxib; Chronic nonspecific low back pain; Eperisone; Radial extracorporeal shock wave therapy (rESWT).

Conflict of interest statement

This study was performed with the radial extracorporeal shock wave device Swiss DolorClast, which was invented and is manufactured and distributed by Electro Medical Systems (Nyon, Switzerland). CS has received research funding at LMU Munich and consulted (until December 31st, 2017) for Electro Medical Systems. However, Electro Medical Systems had no role in study design, data collection, data analysis, data interpretation, or writing of the report. All other authors declare no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Flow of patients in this study according to the Consolidated Standards of Reporting Trials (CONSORT) statement [27]
Fig. 2
Fig. 2
Individual localization of chronic nonspecific low back pain reported by the patients enrolled in this study. The arrows exemplarily indicate patients who reported pain from the first lumbar segment of the spine (L1) to the third lumbar segment of the spine (L3) (a), from L3 to the first sacral segment of the spine (S1) (b) or from the fifth lumbar segment of the spine (L5) to S1 (c), respectively
Fig. 3
Fig. 3
Tukey boxplots of (A) PSEQ score, (B) NRS score, (C) OLBPDQ score and (D) PHQ-9 score of patients suffering from chronic nonspecific low back pain who were treated with respectively rESWT (dark gray bars), rESWT + C + E (light gray bars) or C + E alone (open bars) at baseline (X = 0) and different follow-up times after baseline. Results of statistical analysis using Bonferroni's multiple comparison test are indicated (*, p < 0.05)

References

    1. Balagué F, Mannion AF, Pellisé F, Cedraschi C. Non-specific low back pain. Lancet. 2012;379(9814):482–491. doi: 10.1016/S0140-6736(11)60610-7.
    1. Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017;389(10070):736–747. doi: 10.1016/S0140-6736(16)30970-9.
    1. Skovron ML, Szpalski M, Nordin M, Melot C, Cukier D. Sociocultural factors and back pain. A population-based study in Belgian adults. Spine. 1994;19(2):129–137. doi: 10.1097/00007632-199401001-00002.
    1. Cassidy JD, Carroll LJ, Côté P. The Saskatchewan health and back pain survey. The prevalence of low back pain and related disability in Saskatchewan adults. Spine. 1998;23(17):1860–1866. doi: 10.1097/00007632-199809010-00012.
    1. Bhangle SD, Sapru S, Panush RS. Back pain made simple: an approach based on principles and evidence. Cleve Clin J Med. 2009;76(7):393–399. doi: 10.3949/ccjm.76a.08099.
    1. Yang G, Wang Y, Zeng Y, Gao GF, Liang X, Zhou M, Wan X, Yu S, Jiang Y, Naghavi M, Vos T, Wang H, Lopez AD, Murray CJ. Rapid health transition in China, 1990–2010: findings from the Global Burden of Disease Study 2010. Lancet. 2013;381(9882):1987–2015. doi: 10.1016/S0140-6736(13)61097-1.
    1. Zhang Y, Deng G, Zhang Z, Zhou Q, Gao X, Di L, Che Q, Du X, Cai Y, Han X, Zhao Q. A cross sectional study between the prevalence of chronic pain and academic pressure in adolescents in China (Shanghai) BMC Musculoskelet Disord. 2015;16:219. doi: 10.1186/s12891-015-0625-z.
    1. Carragee EJ. Clinical practice. Persistent low back pain. N Engl J Med. 2005;352(18):1891–1898. doi: 10.1056/NEJMcp042054.
    1. Hoy D, Brooks P, Blyth F, Buchbinder R. The epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010;24(6):769–781. doi: 10.1016/j.berh.2010.10.002.
    1. Stubbs B, Koyanagi A, Thompson T, Veronese N, Carvalho AF, Solomi M, Mugisha J, Schofield P, Cosco T, Wilson N, Vancampfort D. The epidemiology of back pain and its relationship with depression, psychosis, anxiety, sleep disturbances, and stress sensitivity: data from 43 low- and middle-income countries. Gen Hosp Psychiatry. 2016;43:63–70. doi: 10.1016/j.genhosppsych.2016.09.008.
    1. Ma K, Zhuang ZG, Wang L, Liu XG, Lu LJ, Yang XQ, Lu Y, Fu ZJ, Song T, Huang D, Liu H, Huang YQ, Peng BG, Liu YQ. The Chinese Association for the Study of Pain (CASP): consensus on the assessment and management of chronic nonspecific low back pain. Pain Res Manag. 2019;2019:8957847. doi: 10.1155/2019/8957847.
    1. Schmitz C, Császár NB, Milz S, Schieker M, Maffulli N, Rompe JD, Furia JP. Efficacy and safety of extracorporeal shock wave therapy for orthopedic conditions: a systematic review on studies listed in the PEDro database. Br Med Bull. 2015;116(1):115–138. doi: 10.1093/bmb/ldv047.
    1. Maffulli G, Hemmings S, Maffulli N. Assessment of the effectiveness of extracorporeal shock wave therapy (ESWT) for soft tissue injuries (ASSERT): an online database protocol. Transl Med UniSa. 2014;10:46–51.
    1. Maffulli N, Maffulli G. The assessment of the effectiveness of extracorporeal shock wave therapy (ESWT) for soft tissue injuries (ASSERT): two year results. Muscles Ligaments Tendons J. 2018;8(3):399–401. doi: 10.32098/mltj.03.2018.05.
    1. Maffulli N, Maffulli G. The assessment of the effectiveness of extracorporeal shock wave therapy (ESWT) for soft tissue injuries (ASSERT): the future. Muscles Ligaments Tendons J. 2018;8(3):457–458. doi: 10.32098/mltj.03.2018.14.
    1. Nedelka T, Nedelka J, Schlenker J, Hankins C, Mazanec R. Mechano-transduction effect of shockwaves in the treatment of lumbar facet joint pain: comparative effectiveness evaluation of shockwave therapy, steroid injections and radiofrequency medial branch neurotomy. Neuro Endocrinol Lett. 2014;35(5):393–397.
    1. Lee S, Lee D, Park J. Effects of extracorporeal shockwave therapy on patients with chronic low back pain and their dynamic balance ability. J Phys Ther Sci. 2014;26(1):7–10. doi: 10.1589/jpts.26.7.
    1. Han H, Lee D, Lee S, Jeon C, Kim T. The effects of extracorporeal shock wave therapy on pain, disability, and depression of chronic low back pain patients. J Phys Ther Sci. 2015;27(2):397–399. doi: 10.1589/jpts.27.397.
    1. Moon YE, Seok H, Kim SH, Lee SY, Yeo JH. Extracorporeal shock wave therapy for sacroiliac joint pain: a prospective, randomized, sham-controlled short-term trial. J Back Musculoskelet Rehabil. 2017;30(4):779–784. doi: 10.3233/BMR-150405.
    1. Notarnicola A, Maccagnano G, Gallone MF, Mastromauro L, Rifino F, Pesce V, Covelli I, Moretti B. Extracorporeal shockwave therapy versus exercise program in patients with low back pain: short-term results of a randomised controlled trial. J Biol Regul Homeost Agents. 2018;32(2):385–389.
    1. Tomska N, Turoń-Skrzypińska A, Szylińska A, Rył A, Lubińska-Gruszka A, Mosiejczuk H, Rotter I. Deep electromagnetic stimulation and radial shock wave therapy in back pain. Ortop Traumatol Rehabil. 2018;20(3):189–195. doi: 10.5604/01.3001.0012.0943.
    1. Walewicz K, Taradaj J, Rajfur K, Ptaszkowski K, Kuszewski MT, Sopel M, Dymarek R. The effectiveness of radial extracorporeal shock wave therapy in patients with chronic low back pain: a prospective, randomized, single-blinded pilot study. Clin Interv Aging. 2019;14:1859–1869. doi: 10.2147/CIA.S224001.
    1. Walewicz K, Taradaj J, Dobrzyński M, Sopel M, Kowal M, Ptaszkowski K, Dymarek R. Effect of radial extracorporeal shock wave therapy on pain intensity, functional efficiency, and postural control parameters in patients with chronic low back pain: a randomized clinical trial. J Clin Med. 2020;9(2):568. doi: 10.3390/jcm9020568.
    1. Eftekharsadat B, Fasaie N, Golalizadeh D, Babaei-Ghazani A, Jahanjou F, Eslampoor Y, Dolatkhah N. Comparison of efficacy of corticosteroid injection versus extracorporeal shock wave therapy on inferior trigger points in the quadratus lumborum muscle: a randomized clinical trial. BMC Musculoskelet Disord. 2020;21(1):695. doi: 10.1186/s12891-020-03714-3.
    1. Kong L, Tian X, Yao X. Effects of extracorporeal shock wave therapy on chronic low back pain and quality of life. Revista Argent Clin Psicol. 2020;20:883–887. doi: 10.24205/03276716.2020.896.
    1. Çelik A, Altan L, Ökmen BM. The effects of extracorporeal shock wave therapy on pain, disability and life quality of chronic low back pain patients. Altern Ther Health Med. 2020;26(2):54–60.
    1. Schulz KF, Altman DG, Moher D. CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med. 2010;7(3):e1000251. doi: 10.1371/journal.pmed.1000251.
    1. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. (cited 24 Oct 2021)
    1. (cited 24 Oct 2021)
    1. Nicholas MK. The pain self-efficacy questionnaire: taking pain into account. Eur J Pain. 2007;11(2):153–163. doi: 10.1016/j.ejpain.2005.12.008.
    1. Maughan EF, Lewis JS. Outcome measures in chronic low back pain. Eur Spine J. 2010;19(9):1484–1494. doi: 10.1007/s00586-010-1353-6.
    1. Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980;66(8):271–273.
    1. Fairbank JC, Pynsent PB. The oswestry disability index. Spine. 2000;25(22):2940–2952. doi: 10.1097/00007632-200011150-00017.
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–613. doi: 10.1046/j.1525-1497.2001.016009606.x.
    1. Kelsey JL, Whittemore AS, Evans AS, Thompson WD. Methods in observational epidemiology. 2. New York: Oxford University Press; 1996. pp. 311–340.
    1. Fleiss JL, Levin B, Paik MC. Statistical methods for rates and proportions. 3. Hoboken: Wiley; 2003.
    1. (cited 24 Oct 2021).
    1. (cited 24 Oct 2021).
    1. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. doi: 10.1136/bmj.c869.10.1136/bmj.c869.
    1. Yang J, Wei Q, Ge Y, Meng L, Zhao M. Smartphone-based remote self-management of chronic low back pain: a preliminary study. J Healthc Eng. 2019;2019:4632946. doi: 10.1155/2019/4632946.
    1. (cited 24 Oct 2021).
    1. Verhagen AP, de Vet HC, de Bie RA, Kessels AG, Boers M, Bouter LM, Knipschild PG. The Delphi list: a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus. J Clin Epidemiol. 1998;51(12):1235–1241. doi: 10.1016/s0895-4356(98)00131-0.
    1. Hancock MJ, Maher CG, Latimer J, McLachlan AJ, Cooper CW, Day RO, Spindler MF, McAuley JH. Assessment of diclofenac or spinal manipulative therapy, or both, in addition to recommended first-line treatment for acute low back pain: a randomised controlled trial. Lancet. 2007;370(9599):1638–1643. doi: 10.1016/S0140-6736(07)61686-9.
    1. Cohen MM, Smit V, Andrianopoulos N, Ben-Meir M, Taylor DM, Parker SJ, Xue CC, Cameron PA. Acupuncture for analgesia in the emergency department: a multicentre, randomised, equivalence and non-inferiority trial. Med J Aust. 2017;206(11):494–499. doi: 10.5694/mja16.00771.
    1. Zaringhalam J, Manaheji H, Rastqar A, Zaringhalam M. Reduction of chronic non-specific low back pain: a randomised controlled clinical trial on acupuncture and baclofen. Chin Med. 2010;5:15. doi: 10.1186/1749-8546-5-15.
    1. (cited 24 Oct ber 2021).
    1. Schwind J, Learman K, O'Halloran B, Showalter C, Cook C. Different minimally important clinical difference (MCID) scores lead to different clinical prediction rules for the Oswestry disability index for the same sample of patients. J Man Manip Ther. 2013;21(2):71–78. doi: 10.1179/2042618613Y.0000000028.
    1. Maier M, Averbeck B, Milz S, Refior HJ, Schmitz C. Substance P and prostaglandin E2 release after shock wave application to the rabbit femur. Clin Orthop Relat Res. 2003;406:237–245. doi: 10.1097/01.blo.0000030173.56585.8f.
    1. Ohtori S, Inoue G, Mannoji C, Saisu T, Takahashi K, Mitsuhashi S, Wada Y, Takahashi K, Yamagata M, Moriya H. Shock wave application to rat skin induces degeneration and reinnervation of sensory nerve fibres. Neurosci Lett. 2001;315(1–2):57–60. doi: 10.1016/s0304-3940(01)02320-5.
    1. Beaman DN, Graziano GP, Glover RA, Wojtys EM, Chang V. Substance P innervation of lumbar spine facet joints. Spine. 1993;18(8):1044–1049. doi: 10.1097/00007632-199306150-00014.
    1. Kallakuri S, Singh A, Chen C, Cavanaugh JM. Demonstration of substance P, calcitonin gene-related peptide, and protein gene product 9.5 containing nerve fibers in human cervical facet joint capsules. Spine. 2004;29(11):1182–1186. doi: 10.1097/00007632-200406010-00005.
    1. El-Bohy A, Cavanaugh JM, Getchell ML, Bulas T, Getchell TV, King AI. Localization of substance P and neurofilament immunoreactive fibers in the lumbar facet joint capsule and supraspinous ligament of the rabbit. Brain Res. 1988;460(2):379–382. doi: 10.1016/0006-8993(88)90386-1.
    1. Cavanaugh JM, Lu Y, Chen C, Kallakuri S. Pain generation in lumbar and cervical facet joints. J Bone Joint Surg Am. 2006;88(Suppl 2):63–67. doi: 10.2106/JBJS.E.01411.
    1. Shah JP, Danoff JV, Desai MJ, Parikh S, Nakamura LY, Phillips TM, Gerber LH. Biochemicals associated with pain and inflammation are elevated in sites near to and remote from active myofascial trigger points. Arch Phys Med Rehabil. 2008;89(1):16–23. doi: 10.1016/j.apmr.2007.10.018.
    1. Kenmoku T, Ochiai N, Ohtori S, Saisu T, Sasho T, Nakagawa K, Iwakura N, Miyagi M, Ishikawa T, Tatsuoka H, Inoue G, Nakamura J, Kishida S, Saito A, Takahashi K. Degeneration and recovery of the neuromuscular junction after application of extracorporeal shock wave therapy. J Orthop Res. 2012;30(10):1660–1665. doi: 10.1002/jor.22111.
    1. Zhang D, Kearney CJ, Cheriyan T, Schmid TM, Spector M. Extracorporeal shockwave-induced expression of lubricin in tendons and septa. Cell Tissue Res. 2011;346(2):255–262. doi: 10.1007/s00441-011-1258-7.
    1. Taguchi M, Sun YL, Zhao C, Zobitz ME, Cha CJ, Jay GD, An KN, Amadio PC. Lubricin surface modification improves extrasynovial tendon gliding in a canine model in vitro. J Bone Joint Surg Am. 2008;90(1):129–135. doi: 10.2106/JBJS.G.00045.
    1. Klonschinski T, Ament SJ, Schlereth T, Rompe JD, Birklein F. Application of local anesthesia inhibits effects of low-energy extracorporeal shock wave treatment (ESWT) on nociceptors. Pain Med. 2011;12(10):1532–1537. doi: 10.1111/j.1526-4637.2011.01229.x.
    1. Rompe JD, Meurer A, Nafe B, Hofmann A, Gerdesmeyer L. Repetitive low-energy shock wave application without local anesthesia is more efficient than repetitive low-energy shock wave application with local anesthesia in the treatment of chronic plantar fasciitis. J Orthop Res. 2005;23(4):931–941. doi: 10.1016/j.orthres.2004.09.003.
    1. Labek G, Auersperg V, Ziernhöld M, Poulios N, Böhler N. Einfluss von Lokalanästhesie und Energieflussdichte bei niederenergetischer Extrakorporaler Stosswellentherapie der chronischen Plantaren Fasziitis -- Eine prospektiv-randomisierte klinische Studie [Influence of local anesthesia and energy level on the clinical outcome of extracorporeal shock wave-treatment of chronic plantar fasciitis] Z Orthop Ihre Grenzgeb. 2005;143(2):240–246. doi: 10.1055/s-2004-832379.
    1. Park KH, Lee SC, Yuk JE, Kim SR, Lee JH, Park JW. Eperisone-induced anaphylaxis: pharmacovigilance data and results of allergy testing. Allergy Asthma Immunol Res. 2019;11(2):231–240. doi: 10.4168/aair.2019.11.2.231.
    1. Fujioka M, Kuriyama H. Eperisone, an antispastic agent, possesses vasodilating actions on the guinea-pig basilar artery. J Pharmacol Exp Ther. 1985;235(3):757–763.

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