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. |