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

Lewis 2005.

Study characteristics
Methods Study design: RCT
Setting: England, healthcare
Exercise groups: 2
Comparison groups: 0
Participants Number of participants: 80 (E1 = 40, E2 = 40)
Chronic LBP duration: Not specified (long)
Neurological/radicular symptoms: No participants
Mean age (years): 46
Sex (female): 65%
Interventions Exercise Group 1 (E1): Treadmill, exercise bicycle, sit to stand repetitions, spinal stabilisation exercises (supine, prone, 4‐point kneeling), upper and lower extremity exercises; type = mixed; duration = 8 weeks; dose = low; design = partially individualised; delivery = group; additional intervention = advice/education & manual therapy
Exercise Group 2 (E2): Spinal stabilisation exercises; type = core strengthening; duration = 8 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = advice/education & manual therapy
Outcomes Core outcomes reported: Pain (Visual Analogue Scale); function (Quebec Back Pain Disability Scale)
Follow‐up time periods available for syntheses: 8 weeks (short); 26 weeks (moderate); 52 weeks (long)
Notes Conflicts of interest: None to declare
Funding source: No funding received
Other: None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Using random number tables, subjects were assigned to Group 1 (exercise class) or Group 2 (individual treatment).
Allocation concealment (selection bias) High risk Not described
Blinding of participants and personnel (performance bias)
All outcomes High risk The nature of the interventions precluded any blinding of physiotherapists or participants to the assigned treatments.
Blinding of care provider (performance bias) High risk The nature of the interventions precluded any blinding of physiotherapists or participants to the assigned treatments.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Two assessors blinded to group allocation administered questionnaires and conducted physical assessments, before group allocation.
Incomplete outcome data (attrition bias)
All outcomes Low risk Out of 80, 17 were lost and are detailed in Figure 1.
Participants analysed in group allocated (attrition bias) Low risk In this study, the data from each participant was analysed in accordance with the intention‐to‐treat approach.
Selective reporting (reporting bias) Low risk Support for judgement was not available.
Groups similar at baseline (selection bias) High risk After randomisation, there was no statistical difference between the groups.
Co‐interventions avoided or similar (performance bias) Low risk In the exercise group, three subjects required additional conservative treatment at the end of their treatment programme, five at six months and six at 12 months.
Compliance acceptable in all groups (performance bias) Low risk There was a steady decline in the reported compliance of the home exercises over the one‐year follow‐up period.
Timing of outcome assessment similar in all groups (detection bias) Low risk Support for judgement was not available.