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

Vollenbroek‐Hutten 2004.

Study characteristics
Methods Study design: RCT
Setting: Netherlands, healthcare
Exercise groups: 1
Comparison groups: 1
Participants Number of participants: 163 (E1 = 79, C1 = 84)
Chronic LBP duration: 60 months (long)
Neurological/radicular symptoms: Some participants
Mean age (years): 39
Sex (female): Not reported
Interventions Exercise Group 1 (E1): Conditional training and sport, swimming; type = mixed; duration = 8 weeks; dose = high; design = standardised; delivery = group; additional intervention = psychological therapy & electrotherapy & manual therapy & back school
Comparison Group 1 (C1): Usual care/no treatment (control group: continued with normal activity and treatment)
Outcomes Core outcomes reported: Function (Roland‐Morris Disability Questionnaire); HRQoL (EuroQol 5D)
Follow‐up time periods available for syntheses: 8 weeks (short); 26 weeks (moderate)
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 After the baseline measurements, patients were put into either the control group or the treatment group using the minimization method.
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias)
All outcomes High risk Patients could not be blinded for the group to which they were randomised, neither could the therapist who conducted the general physical condition measurement.
Blinding of care provider (performance bias) High risk Patients could not be blinded for the group to which they were randomised, neither could the therapist who conducted the general physical condition measurement.
Blinding of outcome assessment (detection bias)
All outcomes Low risk The researchers conducted all other measurements, and they were blinded for the group to which the patients were randomised.
Incomplete outcome data (attrition bias)
All outcomes Low risk Of the 163 patients who were included in the trial, 21 patients were lost during follow‐up (13%).
Participants analysed in group allocated (attrition bias) Low risk For all analyses, an intention‐to‐treat analysis, including patients with protocol deviations, was performed and results were considered statistically.
Selective reporting (reporting bias) Low risk Support for judgement was not available.
Groups similar at baseline (selection bias) Low risk There were no differences in any of these baseline characteristics between the treatment and control group
Co‐interventions avoided or similar (performance bias) Low risk Support for judgement was not available.
Compliance acceptable in all groups (performance bias) Low risk Support for judgement was not available.
Timing of outcome assessment similar in all groups (detection bias) Low risk Support for judgement was not available.