Efficacy and tolerability of the non-benzodiazepine antispasmodic methocarbamol for the short-term treatment of acute low back pain over 3 days - results of a patient-level pooled re-analysis of depersonalized data from two double-blind randomized placebo-controlled clinical trials evaluating oral and intravenous use. (METABO)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Patient-level pooled re-analysis of data from studies done in the past

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (M03BA03) methocarbamol

  methocarbamol
• Medical condition to be studied:
  Back pain

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)
• Estimated number of subjects:
  359

Study design details

• Main study objective:
  The main objective of this re-analysis is to gain further insight into the differential effects of methocarbamol (given either iv or po) vs. placebo for the immediate short-term treatment of acute low back pain in adult patients.
• Outcomes:
  The primary outcome of this study is the evaluation of the 72-hour response rate, based a) on the documented degree of pain relief (improvement ≥20mm VAS and/or ≥50% vs. baseline), b) finger-to-floor distance (improvement ≥15cm and/or ≥50% vs. baseline), c) pain-related movement restrictions (none or mild), d) Lasègue sign (negative), and e) pain-related disturbances of night sleep (none). Secondary outcomes of this study focus on the overall response to study medication for all five efficacy criteria mentioned above and all three post-baseline evaluation timepoints (24, 48, and 72 hours), percentage and timepoint of patients stopping study medication due to complete vanishing of pain, as well as premature treatment discontinuations due to adverse events, inadequate efficacy and/o
• Data analysis plan:
  Descriptive and inferential statistical analyses will be performed as reported. For continuous variables, descriptive statistics will be summarized by the number of patients (n), the mean, standard deviation (SD), 95% confidence intervals (95%-CI) of the mean, median, and range (minimum – maximum) values. For categorical and ordinal variables data will be summarized by frequency number (n), and percentage (%) of participants in each category, incl. 95% confidence intervals. For between groups comparisons of 2x2 contingency tables with a dichotomous/binomial trait the Chi-Square test will be applied, and Pearson's chi-squared tests will be used for categorial variables with multinomial expressions. Between groups comparisons of continuous variables will be applied dependent on the data distribution: for normally distributed data paired samples t-tests and for non-normal distributions Wilcoxon´s signed rank test will be performed.