Study characteristics |
Methods |
Study design: RCT
Setting: Italy, healthcare
Exercise groups: 1
Comparison groups: 2 |
Participants |
Number of participants: 75 (E1 = 25, C1 = 25, C2 = 25)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: Some participants
Mean age (years): 55
Sex (female): 72% |
Interventions |
Exercise Group 1 (E1): Stretching, strengthening, postural exercises, breathing exercises; type = mixed; duration = 4 weeks; dose = low; design = standardised; delivery = group; additional intervention = psychological therapy & back school
Comparison Group 1 (C1): Usual care/no treatment (control group: no intervention, only medical/pharmacological assistance)
Comparison Group 2 (C2): Other conservative treatment (back school) |
Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Oswestry Disability Index)
Follow‐up time periods available for syntheses: 4 weeks (short); 12 weeks (short); 26 weeks (moderate) |
Notes |
Conflicts of interest: Not reported
Funding source: No funding received
Other: None |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Specifically, patients were asked to take a sealed envelope from a box, containing a piece of paper with the assignment which was concealed. |
Allocation concealment (selection bias) |
Low risk |
Patients were asked to take a sealed envelope from a box, containing a piece of paper with the assignment, which was concealed. |
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 |
Low risk |
Each patient was assessed before and at the end of treatment and also at the 12‐ and 24‐week follow‐up by the same physician, who was unaware of the allocation. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All scores of the 25 participants in each group were recorded and analysed statistically. |
Participants analysed in group allocated (attrition bias) |
Low risk |
An intention‐to‐treat analysis was performed. |
Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
Groups similar at baseline (selection bias) |
Low risk |
At baseline, no significant differences were observed between groups. |
Co‐interventions avoided or similar (performance bias) |
Low risk |
The same drugs were permitted in the three groups. |
Compliance acceptable in all groups (performance bias) |
Unclear risk |
Not described |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |