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

Objectives: 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= 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

Prevalence, etiology, and biopsychosocial risk factors of cervicogenic dizziness in patients with neck pain: A multi-center, cross-sectional study

Objectives: This study aims to investigate the prevalence, etiology, and risk factors of cervicogenic dizziness in patients with neck pain. Patients and methods: Between June 2016 and April 2018, a total of 2,361 patients (526 males, 1,835 females; mean age: 45.0 +/- 13.3 years; range, 18 to 75 years) who presented with the complaint of neck pain lasting for at least one month were included in this prospective, cross-sectional study. Data including concomitant dizziness, severity, and quality of life (QoL) impact of vertigo (via Numeric Dizziness Scale [NDS]), QoL (via Dizziness Handicap Inventory [DHI]), mobility (via Timed Up-and-Go [TUG] test), balance performance [via Berg Balance Scale [BBS]), and emotional status (via Hospital Anxiety Depression Scale [HADS]) were recorded. Results: Dizziness was evident in 40.1% of the patients. Myofascial pain syndrome (MPS) was the most common etiology for neck pain (58.5%) and accompanied with cervicogenic dizziness in 59.7% of the patients. Female versus male sex (odds ratio [OR]: 1.641, 95% CI: 1.241 to 2.171, p=0.001), housewifery versus other occupations (OR: 1.285, 95% CI: 1.006 to 1.642, p=0.045), and lower versus higher education (OR: 1.649-2.564, p<0.001) significantly predicted the increased risk of dizziness in neck pain patients. Patient with dizziness due to MPS had lower dizziness severity scores (p=0.034) and milder impact of dizziness on QoL (p=0.005), lower DHI scores (p=0.004), shorter time to complete the TUG test (p=0.001) and higher BBS scores (p=0.001). Conclusion: Our findings suggest a significant impact of biopsychosocial factors on the likelihood and severity of dizziness and association of dizziness due to MPS with better clinical status