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A randomized, parallel-group, Phase IV study was conducted to assess the safety and effectiveness of Thiocolchicoside (TCC) ointment vs. placebo for the management of low back pain (LBP) alongside muscle spasms.
In terms of reducing the number of days with pain and facilitating an earlier functional recovery, topical Thiocolchicoside can be an appropriate option in patients dealing with mild chronic low back pain accompanied by acute muscle spasms.
A randomized, parallel-group, Phase IV study was conducted to assess the safety and effectiveness of Thiocolchicoside (TCC) ointment vs. placebo for the management of low back pain (LBP) alongside muscle spasms.
Overall, 292 adult volunteers participated in the study. Among them, 106 were male, and 186 were female, with a mean age of 38.5 years (ranging from 18 to 64 years). These participants were randomly assigned to either the TCC group, consisting of 147 individuals, or the placebo group, comprising 145 subjects. However, 8 people from each group were not included in the analysis.
In this multi-center, double-blind study, the pressure pain threshold (PPT) on day 3, assessed using a pressure algometer was the major endpoint ascertained. Secondary endpoints included an evaluation of safety, patient and physician assessments of pain using a visual analog scale (VAS) on both day 3 and day 7, as well as PPT on Day 7.
There were no discernible differences in the PPT values between the treatment groups on day 3. Likewise, both the TCC and placebo groups exhibited comparable VAS scores throughout the trial period. Notably, both groups showed substantially greater PPT values and declined VAS scores on both day 3 and day 7.
In individuals with a PPT value of 3.87 or higher, the TCC group demonstrated a greater PPT on day 3 in comparison with the placebo group. A total of 3 subjects, 2 from the TCC group and 1 from the placebo group, discontinued the trial because of adverse events.
In a subset of people who experienced mild chronic LBP along with muscle spasms, the application of TCC topically proved to be a suitable treatment choice. Specifically, for those with lower pain intensity, TCC provided earlier pain relief. The findings from this trial were in alignment with the treatment methods commonly used in routine clinical practice.
Turkish Journal of Physical Medicine and Rehabilitation
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
Ayşegül Ketenci et al.
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