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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