Effectiveness and tolerability of high-dose methocarbamol vs. typical strong and long-acting opioidanalgesics (LAO) as add-on measure in patients with (low) back pain refractory to recommended 1st. line treatments: retrospective analysis of open-label real-world data provided by the German Pain e-Registry. (COMET)

Study type

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

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Pain
• Additional medical condition(s):
  Chronic low back pain

Population studied

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

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  750

Study design details

• Main study objective:
  Primary objective is the evaluation of the analgesic efficacy of an oral treatment with either high-dose methocarbamol (Ortoton® forte, ORF) vs. typical strong and long-acting opioid-analgesics (LAO) in comparable patient populations of the German Pain e-Registry (GPeR) with insufficient pain relief following recommended/established 1st line treatments.
• Outcomes:
  The primary efficacy variable is the absolute change of the average 24-hr. pain intensity index (PIX, calculated as the arithmetic mean of the lowest, medium and highest 24-hr. pain intensity scores reported by patients. Secondary outcomes will be based on pre-post evaluations (i.e. baseline to end of week-4 differences) for absolute/relative (percent) change of the average 24h pain intensity index (PIX), (L)BP-related disabilities in daily life (mPDI), physical/mental QoL (VR12), and EQ5D
• Data analysis plan:
  A mixed-model repeated measures (MMRM) covariance analysis adjusted for potential confounding factors such as age, gender, pain severity (von Korff scale), stage of chronification, history/duration of pain, comorbidity, comedication, prior medication, and baseline value) will be the primary analytical technique to evaluate the primary efficacy measure. The absolute least squares (LS) mean PIX difference between treatments (cohort A minus cohort B) after 1, 2, 3, and 4 weeks of treatment along with their 2-sided 95% confidence intervals (CI) will be calculated based on the model. If the upper bound of the 95% CI does not exceed +10.0, it will be concluded that ORF is not inferior to LAO.