Localised Neuropathic Pain (LNP) managed in the primary care setting in France, Ireland, Italy, Spain, and the United Kingdom: A cross-sectional study of prevalence, clinical characteristics, treatment patterns and patient’s reported outcomes

Study type

• Study topic:
  Disease /health condition

  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Pain management

Population studied

• Short description of the study population:
  Patients showing signs and symptoms of localised neuropathic pain (LNP) in the primary care setting in France, Ireland, Italy, Spain, and the United Kingdom.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  To describe treatment characteristics and patterns of treatment of LNP patients identified among chronic pain patients in primary care in 5 EU countries.
• Outcomes:
  The primary endpoints for the study will be the important clinical and treatment characteristics at the time of the visit, including but not limited to: clinical characteristics, aetiology of LNP, co-morbidities and therapy for chronic pain in the 6 moths preceding the screening, current analgesia for chronic pain, - EQ-5D score (Patient’s self-reported health status) - CPSI scores (Patient’s self-reported quality of sleep) - Prevalence of LNP
• Data analysis plan:
  Analyses will be mainly descriptive in nature. Categorical data will be summarized by counts and percentages. Continuous data will be summarized using number, mean, standard deviation (SD), median, quartiles, minimum and maximum and in the case of non-normally distributed data, median, range and interquartile range. All statistical tests used for comparisons to assess differences or associations will be 2-sided and conducted at the 0.05 alpha level. P-values will be presented to three decimal places.