Clinical efficacy of tolperisone hydrochloride sustained release tablets in patients with acute or exacerbation of chronic musculoskeletal pain

Devlikamova F.I.

doi:https://doi.org/10.17116/pain20222004135

Devlikamova F.I.

Kazan State Medical Academy

Clinical efficacy of tolperisone hydrochloride sustained release tablets in patients with acute or exacerbation of chronic musculoskeletal pain

Authors:

Devlikamova F.I.

More about the authors

Journal: Russian Journal of Pain. 2022;20(4): 35‑44

DOI: 10.17116/pain20222004135

Read: 3195 times

Download PDF (RU)

Contact the author

Table of contents

To cite this article:

Devlikamova FI. Clinical efficacy of tolperisone hydrochloride sustained release tablets in patients with acute or exacerbation of chronic musculoskeletal pain. Russian Journal of Pain. 2022;20(4):35‑44. (In Russ.)
https://doi.org/10.17116/pain20222004135

Подписка 2025 Российский журнал боли (Russian Journal of Pain)

Использование инфографики авторами научных работ

Close metadata

OBJECTIVE

To analyze clinical efficacy of tolperisone hydrochloride sustained release tablets 450 mg daily in patients with acute or exacerbation of chronic musculoskeletal pain.

MATERIAL AND METHODS

Thirty patients with acute or exacerbation of chronic musculoskeletal pain were enrolled (mean age 44.7±3.8 years). The study was conducted according to a registered indication for Mydocalm Long (treatment of painful muscle spasm associated with musculoskeletal disorders). Patients received Mydocalm Long once a day after meal for 14 days. All patients underwent clinical examination before intake of the drug, 7 and 14 days later. We used visual and verbal analogue scales, the Roland-Morris functional impairment scale, the muscle syndrome index, the EQ-5D-3L quality of life questionnaire (Russian version) and assessment of treatment effectiveness with Global Clinical Impression.

RESULTS

Analgesic effect of Mydocalm Long was significant by the 7^th day of treatment while maximum effect of therapy was noted after 14 days. After 7 days, Roland-Morris functional impairment score decreased by 47%, after 14 days — by 85%. Muscle syndrome index (median before treatment — 12) was 7 after 7 days and 2 after 14 days (p<0.001). Analysis of EQ-5D-3L data showed increase in the quality of life that was manifested by significant change in each of 5 indicators of this questionnaire. Assessment of global clinical impression showed a positive trend. Significant clinical effect was observed in most patients by the 14^th day of Mydocalm Long therapy.

CONCLUSION

We have demonstrated clinical efficacy of tolperisone hydrochloride sustained release tablets 450 mg in patients with acute or exacerbation of chronic musculoskeletal pain.

Keywords:

acute musculoskeletal pain

exacerbation of chronic musculoskeletal pain

tolperisone hydrochloride sustained release tablets 450 mg

clinical efficacy

Authors:

Devlikamova F.I.

Kazan State Medical Academy

Received:

01.09.2022

Accepted:

08.09.2022

Close metadata

References:

Danilov AB, Korzhavina VB. New therapeutic options for musculoskeletal pain. Medical Council. 2019;6:34-40. (In Russ.). https://doi.org/10.21518/2079-701X-2019-6-34-40
Erdes ShF, Dubinina TV, Galushko EA. Low back pain in general medical practice. Therapeutic Archive. 2008;80(5):59-61. (In Russ.).
Wolsko PM, Eisenberg DM, Davis RB, Kessler R, Phillips RS. Patterns and perceptions of care for treatment of back and neck pain: results of a national survey. Spine. 2003;28:292-297. https://doi.org/10.1097/01.BRS.0000042225.88095.7C
Classification of Chronic Pain, Second Edition. IASP Task Force on Taxonomy. Merskey H, Bogduk N, eds. Seattle: IASP Press; 1994;209-214.
Storheim K, Zwart J. Musculoskeletal disorders and the Global Burden of Disease study. Ann Rheum Dis. 2014;73(6):949-950. https://doi.org/10.1136/annrheumdis-2014-205327
Petersen T, Laslett M, Juhl C. Clinical classification in low back pain: best-evidence diagnostic rules based on systematic reviews. BMC Musculoskeletal Disorders. 2017;18(1):188. https://doi.org/10.1186/s12891-017-1549-6
Karateev AE, Nasonov EL, Ivashkin VT, et al. Rational use of nonsteroidal anti-inflammatory drugs. Clinical guidelines. Rheumatology Science and Practice. 2018;56(suppl 1):1-29 (In Russ.). https://doi.org/10.14412/1995-4484-2018-1-29
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). Neurology, Neuropsychiatry, Psychosomatics. 2018;10(2):4-11. https://doi.org/10.14412/2074-2711-2018-2-4-11
Almeida M, Saragiotto B, Maher CG. Primary care management of non-specific low back pain: key messages from recent clinical guidelines. The Medical Journal of Australia. 2018;209(5):235-235.e1. https://doi.org/10.5694/mja18.00446
Stochkendahl MJ, Kjaer P, Hartvigsen J, et al. National Clinical Guidelines for nonsurgical treatment of patients with recent onset low back pain or lumbar radiculopathy. European Spine Journal. 2018;27(1):60-75. https://doi.org/10.1007/s00586-017-5099-2
Kukushkin ML. Tolperisone: mechanism of action, clinical efficacy and safety in the treatment of musculoskeletal pain. Russian Journal of Pain. 2022;20(2):63-67. (In Russ.). https://doi.org/10.17116/pain20222002163
Ono H, Fukuda H, Kudo Y. Mechanisms of depressant action of muscle relaxants on spinal reflexes: participation of membrane stabilizing action. J Pharmacobiodyn. 1984;7(3):171-176. https://doi.org/10.1248/bpb1978.7.171
Farkas S, Kocsis P, Bielik N. Comparative characterisation of the centrally acting relaxant RGH:5002 and tolperisone and of lidocaine based on their effects on rat spinal cord in vitro. Neurobiology. 1997;5(1):57-58.
Dulin J, Kovacs L, Ramm S, et al. Evaluation of sedative effects of single repeated doses of 50 mg and 150 mg Tolperisone Hydrochloride. Results of prospective, randomized, double-blind, placebo-control trial. Pharmacopsychiatry. 1998;31(4):136-142. https://doi.org/10.1055/s-2007-979315
Skoromets AA, Gekht AB, Galanov DV, et al. The results of the multicenter pharmaco-epidemiological observational project on the use of mydocalm in the treatment of pain syndromes with the muscle spasm. S.S. Korsakov Journal of Neurology and Psychiatry. 2015;115(12):104-109. (In Russ.). https://doi.org/10.17116/jnevro2015115112104-109
Kukushkin ML, Brylev LV, Laskov VB, et al. Results of a randomized double blind parallel study on the efficacy and safety of tolpersione in patients with acute nonspecific low back pain. S.S. Korsakov Journal of Neurology and Psychiatry. 2017;117(11):69-78. (In Russ.). https://doi.org/10.17116/jnevro201711711169-78
Parfenov VA, Bogdanov EI, Laskov VB, et al. Multicenter, randomized, double-blind study of the efficacy and safety of prolonged release tolperisone hydrochloride 450 mg (once daily) and tolperisone hydrochloride (Mydocalm) 150 mg (three times daily) for acute non-specific lower back pain. Neurology, Neuropsychiatry, Psychosomatics. 2021;13(6):14-22. (In Russ.). https://doi.org/10.14412/2074-2711-2021-6-14-22
Samartsev IN, Zhivolupov SA. Medical adherence as the basis for effective therapy — current state of the art. S.S. Korsakov Journal of Neurology and Psychiatry. 2021;121(12):1-6. (In Russ.). https://doi.org/10.17116/jnevro202112112151
Instructions for medical use of the drug Mydocalm® Long. (In Russ.).
Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine. 1983;8(2):141-144. https://doi.org/10.1097/00007632-198303000-00004
Khabirov FA, Khabirov RA. Muscle pain. Kazan: Knizhnyj dom; 1995;208. (In Russ.).
Aleksandrova E.A., Khabibullina A.R. Methodology for assessing health-related quality of life using the EQ-5D-3L questionnaire. Rossijskij meditsinskij zhurnal. 2019;25(4):202-209. (In Russ.). https://doi.org/10.18821/0869-2106-2019-25-4-202-209
Brooks R. EuroQol: The current state of play. Health Policy. 1996;37(1):53-72. https://doi.org/10.1016/0168-8510(96)00822-6
Szende A, Oppe M, Devlin N. EQ-5D value sets: inventory, comparative review and user guide. Berlin: Springer; 2007;107. https://doi.org/10.1007/1-4020-5511-0