Biopsychosocial characteristics of patients with fibromyalgia / chronic widespread pain. A cross-sectional review of depersonalized data from the German Pain e-Registry. (F-type Pain)

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
• 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:
  Fibromyalgia

Population studied

• Short description of the study population:
  Anonymized real-world data of patients derived from routine medical care in pain centers within the German Pain e-Registry (GPeR), a national web-based registry developed in cooperation with the German Pain Association (Deutsche Gesellschaft für Schmerzmedizin) and the German Pain League (Deutsche Schmerzliga).
• 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:
  Fibromyalgia
• Estimated number of subjects:
  15000

Study design details

• Main study objective:
  To assess the extend of the biopsychosocial burden in patients with FM/CWSP
• Data analysis plan:
  Biometric analyses will beperformed using the descriptive procedures suitable for the respective data format. Mean data will be presented with standard deviation or 95% confidence intervals (CI), proportions expressed in percent (%) and if necessary, adjusted for the number of patients with available data (a%). For statistical between subcohort comparisons Pearson’s chi-square test and Wilcoxon’s signed rank test will be performed using a two-sided significance level of 0.05. All comparisons will be exploratory, therefore neither significance levels will be adjusted for multiplicity nor confirmatory analyses performed. All analyses will be conducted with PASW Statistics version 18.