Pridinol vs. nsaids - efficacy/tolerability in acute (low) back pain. A propensity-score matched, comparative 2-cohort, 4-week real world evidence analysis of depersonalized data from the German Pain e-Registry in patients refractory to self-medication. (Providence)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Back pain

Population studied

• Short description of the study population:
  The study population included patients with acute (low) back pain received treatment with pridinol and traditional nonsteroidal anti-inflammatory agents identified through the German Pain e-Registry (GPeR).
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with low back pain
• Estimated number of subjects:
  934

Study design details

• Main study objective:
  To assess differential treatment effects reported by acute low back pain patients who were switched to the index medications after failure of pain reliefing self medication
• Outcomes:
  Responder analysis, i.e. percentage of patients who did not discontinue treatment due to a drug-related adverse event and who reported after 4 weeks a pain intensity improvement and a reduction of pain-related disabilities ≤-20mm VAS (MCID) or ≤-50 percent vs baseline without a relevant worsening of their physical and mental quality of life. Secondary efficacy analyses will be done with respect to the absolute/relative change of pain intensity, pain-related disability in daily life, physical and mental quality of life, as well as frequency and spectrum of drug-related adverse events.
• Data analysis plan:
  Exploratory analysis of anonymized 4-week routine/open-label real-world data provided by the German Pain e-Registry (GPeR) on adult patients with acute low back pain, in whom a treatment with pridinol or nsaids has been initiated in compliance with the current German prescribing regulations before April 30, 2022. Selection of treatment cases will base on a propensity score analysis (nearest neighbour technique, caliper 0.15, etc.) based on age, gender as well as pain intensity (VAS), pain-related disabilities, duration of current pain symptoms, pain severity grading due to von Korff, stage of chronification, comedication, treatment indication and previous self medication. No formal sample size analysis will be performed. Data analyses will be performed for all patients identified through the aforementioned selection process.