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Table 4 Suggested examples for the clear reporting of entry criteria, by commonly reported domains

From: Inclusion and exclusion criteria used in non-specific low back pain trials: a review of randomised controlled trials published between 2006 and 2012

Criterion/a Examples
Anatomical region Pain between bottom of ribs and buttock creases
If pain below buttock creases is excluded; state any explicit criteria for exclusions Pain radiating below knee or objective neurological signs in leg
Age Adults – with restrictions by age only if good scientific/clinical reason
Duration Back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months
Serious causes of LBP excluded Malignancy, vertebral fracture, infections
Rheumatologic conditions excluded Ankylosing spondylitis or related conditions
Systemic conditions excluded Cardiovascular, respiratory, neurological, gastrointestinal, urogenital or related conditions
Baseline severity for studies of treatment (i.e not prevention) NRS/VAS ≥ 4/40, or ≥ 15% of score range of a disability measure (e.g 4/24 for RMDQ)
Other patient-characteristics excluded Pregnancy, medico-legal issues, not understanding language, previous or scheduled surgery, psychiatric disorders
Study specific criteria Workers or men or with/without depression
  1. Note: The table shows, for commonly reported domains, a series of examples of the level of detail we suggest is required for the parameters of entry criteria to be sufficiently clear