| Study characteristics |
| Methods |
Study design: RCT
Setting: Italy, healthcare
Exercise groups: 2
Comparison groups: 1 |
| Participants |
Number of participants: 210 (E1 = 70, E2 = 70, C1 = 70)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: Some participants
Mean age (years): 59
Sex (female): 67% |
| Interventions |
Exercise Group 1 (E1): Postural, respiratory, and back exercises; type = mixed; duration = 3 weeks; dose = low; design = partially individualised; delivery = group; additional intervention = advice/education & relaxation
Exercise Group 2 (E2): Active movement exercises selected by physiotherapist; type = mixed; duration = 3 weeks; dose = low; design = individualised; delivery = individual; additional intervention = advice/education & other & physiotherapy
Comparison Group 1 (C1): Other conservative treatment (manual therapy) |
| Outcomes |
Core outcomes reported: Pain (Pain Rating Scale); function (Roland‐Morris Disability Questionnaire); work (sick leave (did you lose any working days because of low back pain in the past six months?))
Follow‐up time periods available for syntheses: 12 weeks (short); 26 weeks (moderate); 52 weeks (long) |
| Notes |
Conflicts of interest: None to declare
Funding source: Fondazione Don Gnocchi Foundation, Scientific Institute
Other: None |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Once enrolled, each patient was given a progressive number and the secretary of the outpatient department assigned patients to their treatment group. |
| Allocation concealment (selection bias) |
Low risk |
The enrolling physician was blind as to which number corresponded to which treatment. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Patients could not be blinded. |
| Blinding of care provider (performance bias) |
High risk |
Patients could not be blinded. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Baseline and follow‐up questionnaires were administered by three independent blinded interviewers at the outpatient department. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Among those assigned to back school, two patients discontinued the treatment, one because of concurrent illness and one because of family problems. |
| Participants analysed in group allocated (attrition bias) |
High risk |
Five patients lost to follow‐up |
| Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
| Groups similar at baseline (selection bias) |
Low risk |
No significant differences |
| Co‐interventions avoided or similar (performance bias) |
High risk |
Table 3 shows low back pain recurrences, low back pain‐related use of drugs and request of further treatment for low back pain. |
| Compliance acceptable in all groups (performance bias) |
Low risk |
All participants who completed back school and individual physiotherapy attended at least 12 of the 15 sessions. |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |
