A multi-center, double-blind, randomized parallel-group Phase IV study comparing the efficacy and safety of thiocolchicoside ointment versus placebo in patients with chronic mechanical low back pain and an acute muscle spasm

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dc.contributor.authorKetenci, Ayşegül
dc.contributor.authorSindel, Dilsad
dc.contributor.authorKoca, Tuba Tulay
dc.contributor.authorKarahan, Ali Yavuz
dc.contributor.authorErdal, Akin
dc.contributor.authorAydın, Elif Burcu
dc.contributor.authorGüzel, Rengin
dc.contributor.authorSarıfakıoğlu, Banu
dc.contributor.authorUstaömer, Kübra
dc.date.accessioned2022-05-11T14:39:46Z
dc.date.available2022-05-11T14:39:46Z
dc.date.issued2022
dc.departmentFakülteler, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü, Fizik Tedavi ve Rehabilitasyon Ana Bilim Dalı
dc.description.abstractObjectives: This study aims to evaluate the efficacy and safety of thiocolchicoside (TCC) ointment treatment compared to placebo in patients with chronic mechanical low back pain (LBP) accompanied by acute muscle spasms. Patients and methods: A total of 292 adult patients (106 males, 186 females; mean age: 38.5 +/- 11.2 years; range, 18 to 64 years) were randomized to TCC group (n=147) and placebo group (n=145) in 12 centers between March 2020 and March 2021. Eight patients from each group were excluded from the analysis. The primary endpoint was pressure pain threshold (PPT) on Day 3, which was measured using a pressure algometer. Secondary endpoints were PPT on Day 7, patient, and physician Visual Analog Scales-pain (VAS-pain) on Days 3 and 7, and safety. Results: The PPT values on Day 3 was not significantly different between the treatment groups (p=0.701). Similarly, TCC and placebo group had similar VAS-pain scores over trial period (p=0.577 or higher for comparisons). Significantly higher PPT values and lower VAS-pain scores on Days 3 and 7 were observed in both groups (p<0.001 for all). In patients with a PPT value of >= 3.87, TCC arm had higher PPT on Day 3 compared to placebo (p=0.029). Three patients (two in the TCC arm and one in the placebo arm) discontinued the trial due to an adverse event. Conclusion: Topical TCC can be an appropriate option in a subset of patients with mild chronic LBP accompanied by muscle spasms. In a subset of patients with milder pain intensity, topical TCC may improve pain earlier. The results of this trial are compatible with the treatment approaches used in daily practice.
dc.identifier.doi10.5606/tftrd.2022.9744
dc.identifier.issn2587-1250
dc.identifier.scopus2-s2.0-85146510998
dc.identifier.scopusqualityQ3
dc.identifier.trdizinid1170762
dc.identifier.urihttps://doi.org/10.5606/tftrd.2022.9744
dc.identifier.urihttps://hdl.handle.net/20.500.11776/8706
dc.identifier.wosWOS:000752203400001
dc.identifier.wosqualityQ4
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakTR-Dizin
dc.institutionauthorSarıfakıoğlu, Banu
dc.institutionauthorUstaömer, Kübra
dc.language.isoen
dc.publisherBaycinar Medical Publ-Baycinar Tibbi Yayincilik
dc.relation.ispartofTurkish Journal of Physical Medicine and Rehabilitation
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccess
dc.subjectChronic low back pain
dc.subjectplacebo
dc.subjectpressure pain threshold
dc.subjectthiocolchicoside
dc.subjectPressure Pain
dc.subjectThreshold
dc.titleA multi-center, double-blind, randomized parallel-group Phase IV study comparing the efficacy and safety of thiocolchicoside ointment versus placebo in patients with chronic mechanical low back pain and an acute muscle spasm
dc.typeArticle

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