Tolperisone in the treatment of acute and chronic nonspecific back pain
https://doi.org/10.14412/2074-2711-2020-4-137-142
Abstract
Nonspecific back pain (NBP) is one of the most common reasons to see a neurologist or therapist. Acute (<4 weeks' duration), subacute (4 to 12 weeks), and chronic (>12 weeks) NBPs are recognized. The diagnosis of NBP is based on anamnestic data, somatic, neurological, and neurologic-and-orthopedic examination findings and on the exclusion of the specific causes of back pain, discogenic radiculopathy, and vertebral canal stenosis. Nonsteroidal anti-inflammatory drugs (NSAIDs) and muscle relaxants are used in the pharmacotherapy of acute, subacute, and chronic NBP. Tolperisone is widely used as a muscle relaxant in Russia and in the countries of Europe and Asia. Clinical trials have shown the efficacy and good tolerance of tolperisone used alone and in combination with NSAIDs for NBP. The review presents clinical recommendations from different countries on the use of muscle relaxants in the treatment of acute and chronic NBP. It is concluded that a large-scale qualitative randomized trial should be conducted to investigate the efficacy of muscle relaxants, tolperisone in particular, in the treatment of acute, subacute, and chronic NBP.
Supporting agencies: This article has been supported by OZON Pharmaceuticals. The sponsor has participated in the development of the investigation project and supported the investigation program, as well as in the decision to submit the article for publication.
About the Authors
V. A. Golovacheva
I.M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia
Russian Federation
Russian Federation
Veronika Aleksandrovna Golovacheva
Department of Nervous System Diseases and Neurosurgery, Institute of Clinical Medicine
11, Rossolimo St., Build. 1, Moscow 119021
A. A. Golovacheva
I.M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia
Russian Federation
Russian Federation
Department of Nervous System Diseases and Neurosurgery, Institute of Clinical Medicine
11, Rossolimo St., Build. 1, Moscow 119021
O. E. Zinovyeva
I.M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia
Russian Federation
Russian Federation
Department of Nervous System Diseases and Neurosurgery, Institute of Clinical Medicine
11, Rossolimo St., Build. 1, Moscow 119021
V. L. Golubev
I.M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia
Russian Federation
Russian Federation
Department of Nervous System Diseases, Institute of Professional Education
86, Shosse Entuziastov, Moscow 1111223
References
1. Yahno NN, Kukushkin ML, Churyukanov MV, Syrovegin AV. The results of open multicentral study «MERIDIAN» for assessment of pain syndromes prevalence in ambulatory and therapeutic preferences of physicians. Rossiiskii zhurnal boli. 2012;3(36-37):10-4. Available at: https://www.elibrary.ru/item.asp?id=20343058 (In Russ.).
2. Parfenov VA, Yakhno NN, Kukushkin ML, et al. Acute nonspecific (musculoskeletal) low back pain. Guidelines of the Russian Society for the Study of Pain (RSSP). Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, neuropsychiatry, psychosomatics. 2018;10(2):4-11. doi: 10.14412/2074-2711-2018-2-4-11 (In Russ.).
3. Parfenov VA, Yakhno NN, Davydov OS, et al. Chronic nonspecific (musculoskeletal) low back pain. Guidelines of the Russian Society for the Study of Pain (RSSP). Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2019;11(Suppl. 2):7-16. doi: 10.14412/2074-2711-2019-2S-7-16 (In Russ.).
4. Tekes K. Basic aspects of the pharmacodynamics of tolperisone, a widely applicable centrally acting muscle relaxant. Open Med Chem J. 2014;8:17-22. doi: 10.2174/1874104501408010017
5. Skoromets AA, Gekht AB, Galanov DV, et al. Results of the international pharmaco-epidemiological observational project on the use of mydocalm for the treatment of pain syndromes accompanied by muscle spasm. Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova. 2015;115(12):1049. doi: 10.17116/jnevro2015115112104-109 (In Russ.).
6. Nador K, Porszasz J. Pharmakologische und pharmakochemische Studien über betaAminoketone [Pharmacological and pharmacochemical studies on beta-aminoketones]. Arzneimittelforschung. 1958;8(6):313-9 (In Germ.)]. Available at: https://pubmed.ncbi.nlm.nih.gov/13546091/
7. Porszasz J, Nador K, Gibiszer K, Barankay T. The pharmacology of Mydeton (Mydocalm1-piperidino-2-methyl-3-p-tolylpropanone-3), a new interneurone blocking compound. Acta Physiol Hung, 1960;18:149-70. Available at: https://www.wikigenes.org/e/chem/e/5511.html
8. Kocsis P, Gajari D, Deli L, et al. Effect of tolperisone on the resting brain and on evoked responses, an phMRI BOLD study. Brain Res Bull. 2013;99:34-40. doi: 10.1016/j.brainresbull.2013.09.008
9. Pratzel HG, Alken RG, Ramm S. Efficacy and tolerance of repeated oral doses of tolperisone hydrochloride in the treatment of painful reflex muscle spasm: results of a prospective placebocontrolled double-blind trial. Pain. 1996;67(2-3):417-25. doi: 10.1016/0304-3959(96)03187-9
10. Prabhoo R, Keny S, Prabhoo T, et al. A phase IV observational multi-centre, openlabel study on efficacy and safety of tolperisone 150 mg in patients with painful muscle spasm associated with degenerative or inflammatory diseases of the musculoskeletal system. J Assoc Physicians India. 2011;59:33-37. Available at: https://pubmed.ncbi.nlm.nih.gov/21751662/
11. Rao R, Panghate A, Chandanwale A, et al. Clinical comparative study: efficacy and tolerability of tolperisone and thiocolchicoside in acute low back pain and spinal muscle spasticity. Asian Spine J. 2012;6(2):115-22. doi: 10.4184/asj.2012.6.2.115
12. Chiba L, Zhusupova AS, Likhachev SA, et al. Systematic review of the use of muscle relaxants for pain in the lower back. Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova. 2018;118(12):100-13. doi: 10.17116/jnevro2018118121100 (In Russ.).
13. Dulin J, Kovacs L, Ramm S, et al. Evaluation of sedative effects of single and repeated doses of 50 mg and 150 mg tolperisone hydrochloride. Results of a prospective, randomized, double-blind, placebo-controlled trial. Pharmacopsychiatry. 1998;31(4):137-42. doi: 10.1055/s-2007-979315
14. Kukushkin ML, Brylev LV, Laskov VB, et al. Results of a randomized, double-blind, parallel study of the efficacy and safety of tolperisone in patients with acute nonspecific lower back pain. Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova. 2017;117(11):69-78. doi: 10.17116/jnevro201711711169-78 (In Russ.).
15. Verbitskaya SV, Parfenov VA, Borisov KN. Tolperisone (Mydocalm) in the complex therapy of acute low back pain. Klinicheskaya farmakologiya i terapiya. 2008;17(2):36-8. Available at: https://www.elibrary.ru/item.asp?id=11922560 (In Russ.).
16. Bhattacharjya B, Naser SM, Biswas A. Effectiveness of tolperisone hydrochloride with aceclofenac as combined therapy in acute low back pain. Indian J Phys Med Rehabil. 2012;23(2):74-8. Available at: https://www.ijopmr.com/doi/pdf/10.5005/ijop mr-23-2-74
17. Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017;166(7):514-30. doi: 10.7326/M16-2367
18. National Institute for Health and Care Excellence (2016). Low back pain and sciatica in over 16 s: assessment and management (NICE guideline NG59). Available at: http://www.nice.org.uk/34.guidance/ng59
19. NSW Agency for Clinical Inovation (ACI) (2016). Management of people with acute low back pain model of care. Available at: https://www.aci.health.nsw.gov.au/data/assets/pdf_file/0007/336688/acute-low-back-pain-moc.pdf
20. Canada TOP (2015). Evidence-informed primary care management of low back pain. Edmonton (AB): toward optimized practice. Available at: http://www.topalbertadoctors.org/download/1885/LBPguideline.pdf?_20180625085852
21. Pohjolainen T, Leinonen V, Franten J, et al. Alaselkäkipu [Update on Current Care Guideline: Low back pain]. Duodecim. 2015;131(1):92-4. Available at: https://pubmed.ncbi.nlm.nih.gov/26245063/
22. Guevara-Lopez U, Covarrubias-Gomez A, Elias-Dib J, et al; Consensus Group of Practice Parameters to Manage Low Back Pain. Practice guidelines for the management of low back pain. Consensus Group of Practice Parameters to Manage Low Back Pain. Cir Cir. 2011;79(3):264-302. Available at: https://pubmed.ncbi.nlm.nih.gov/22381000/
23. Chenot JF, Greitemann B, Kladny B, et al. Non-specific low back pain. Dtsch Arztebl Int. 2017;114(51-52):883-90. doi: 10.3238/arztebl.2017.0883
24. Stochkendahl MJ, Kjaer P, Hartvigsen J, et al. National Clinical Guidelines for non-surgical treatment of patients with recent onset low back pain or lumbar radiculopathy. Eur Spine J. 2018;27(1):60-75. doi: 10.1007/s00586-017-5099-2
25. Van Wambeke P, Desomer A, Jonckheer P, Depreitere B. The Belgian national guideline on low back pain and radicular pain: key roles for rehabilitation, assessment of rehabilitation potential and the PRM specialist. Eur J Phys Rehabil Med. 2020;56(2):220-7. doi: 10.23736/S1973-9087.19.05983-5
26. Low back pain management guideline. Philippine Academy of Rehabilitation Medicine, 2011. Available at: http://parm.com.ph/wp-content/uploads/2016/09/PARM-Low-Back-PainCPG-2011-1.pdf
27. Elleuch M, El Maghraoui A, Griene B, et al. Consensus formalise: recommandations de pratiques cliniques pour la prise en charge de la lombalgie aiguё du patient africain [Formalized consensus: clinical practice recommendations for the management of acute low back pain of the African patient]. Pan Afr Med J. 2015;22:240. doi: 10.11604/pamj.2015.22.240.8120
28. Hussein AM, Choy Y, Singh D, et al. Malaysian low back pain management guideline Malaysian association for the study of pain, first edition. 2016. Available at: https:// www.masp.org.my/index.cfm?&menuid=23
29. Van Tulder M, Custers J, de Bie R, et al. Ketenzorgrichtlijn aspecifieke lage rugklachten. Belgrade: KKCZ; 2010. Available at: https://richtlijnen.nhg.org/files/2020-05/ketenzorgrichtlijn-aspecifieke-lage-rugklachten.pdf
30. Latorre Marques E. The treatment of low back pain and 29. scientific evidence, low back pain. In: Norasteh AA (ed.). InTech. 2012. doi: 10.5772/33716. Available at: https://www.intec30.hopen.com/books/lowback-pain/the-treatment-of-low-back-painscientific-evidence
31. Rached RDVA, Rosa CDPD, Alfieri FM, et al. Lombalgia inespecifica cronica: reabilitacao. Revista da Associacao Medica Brasileira. 2013;59(6):536-53 Available at: https://www.revistas.usp.br/actafisiatrica/article/download/103692/102160
32. Oliveira CB, Maher CG, Pinto RZ, 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(11):27912803. doi:10.1007/s00586-018-5673-2
Review
For citations:
Golovacheva V.A., Golovacheva A.A., Zinovyeva O.E., Golubev V.L. Tolperisone in the treatment of acute and chronic nonspecific back pain. Neurology, Neuropsychiatry, Psychosomatics. 2020;12(4):137-142. (In Russ.) https://doi.org/10.14412/2074-2711-2020-4-137-142
Views: 13783
Email this article 