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. 2021 Sep 28;2021(9):CD009790. doi: 10.1002/14651858.CD009790.pub2

Gatti 2011.

Study characteristics
Methods Study design: RCT
Setting: Italy, healthcare
Exercise groups: 2
Comparison groups: 0
Participants Number of participants: 79 (E1 = 34, E2 = 45)
Chronic LBP duration: 71.4 months (long)
Neurological/radicular symptoms: Some participants
Mean age (years): 58
Sex (female): 65%
Interventions Exercise Group 1 (E1): Trunk balance exercises and standard trunk flexibility exercises; type = mixed; duration = 5 weeks; dose = low; design = standardised; delivery = group; additional intervention = not specified
Exercise Group 2 (E2): Strengthening exercises and standard trunk flexibility exercises; type = mixed; duration = 5 weeks; dose = low; design = standardised; delivery = group; additional intervention = not specified
Outcomes Core outcomes reported: Pain (Visual Analogue Scale); function (Roland‐Morris Disability Questionnaire); HRQoL (12‐Item Short Form Survey); Global Perceived Health or Recovery (Global Perceived Health or Recovery (patient‐report, improvement or worsening in specific positions))
Follow‐up time periods available for syntheses: 6 weeks (short)
Notes Conflicts of interest: Not reported
Funding source: Not reported
Other: None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Using a computer‐generated list of random numbers created and managed by a physiotherapist who was blinded
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias)
All outcomes High risk Assumed not possible
Blinding of care provider (performance bias) High risk Assumed not possible
Blinding of outcome assessment (detection bias)
All outcomes High risk Assumed not possible
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Five/45 in the control group dropped out because of the intervention.
Participants analysed in group allocated (attrition bias) Low risk Data were analysed using an intention‐to‐treat approach.
Selective reporting (reporting bias) Low risk Support for judgement was not available.
Groups similar at baseline (selection bias) Low risk The two groups were homogeneous at the beginning of the rehabilitation period.
Co‐interventions avoided or similar (performance bias) Unclear risk No suggestion to the participants on drug management was given.
Compliance acceptable in all groups (performance bias) Low risk All participants who completed the study were fully compliant with the intervention programme.
Timing of outcome assessment similar in all groups (detection bias) Low risk Support for judgement was not available.