| Study characteristics |
| Methods |
Study design: RCT
Setting: Portugal, general population
Exercise groups: 1
Comparison groups: 1 |
| Participants |
Number of participants: 46 (E1 = 23, C1 = 23)
Chronic LBP duration: 29 months (moderate)
Neurological/radicular symptoms: Not specified
Mean age (years): 22
Sex (female): 59% |
| Interventions |
Exercise Group 1 (E1): Pilates: exercises focussed on deep stabilisers and hip extensors; type = Pilates; duration = .14 weeks; dose = low; design = standardised; delivery = individual; additional intervention = none
Comparison Group 1 (C1): Usual care/no treatment (control group: rest 20 minutes resting in a sitting position) |
| Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale)
Follow‐up time periods available for syntheses: 0 weeks (short) |
| Notes |
Conflicts of interest: None to declare
Funding source: No funding received
Other: Information modified for author contact; sufficient data not available for inclusion in meta‐analyses |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Block randomisation, 1:1 |
| Allocation concealment (selection bias) |
Low risk |
Allocation concealment was achieved by using numbered sheets inside sealed, opaque envelopes picked up by the participants before baseline data collection. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Patients could not be blinded to allocation due to the nature of the treatments; 2. Intervention only consisted of one session with the assessment occurring right after; it was not possible to deviate from intervention. |
| Blinding of care provider (performance bias) |
Low risk |
1. Care providers could not be blinded to allocation due to the nature of the treatments; 2. Unlikely that lack of care provider blinding caused deviations from the intended intervention as interventions were very structured and distinct; also, entire trial took place in one day |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
1. Outcome assessors for pain and function were the patients themselves, who could not be blinded due to the nature of the treatments; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. Outcomes in a exercise versus no treatment study likely to be altered by knowledge of intervention assignment. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. No dropouts in the study because it took place in a single session |
| Participants analysed in group allocated (attrition bias) |
Low risk |
1. Not explicitly stated, however, one can assume that in a single intervention trial that intention‐to‐treat analysis was inevitable. |
| Selective reporting (reporting bias) |
Low risk |
1. No protocol or statistical analysis plan found: all planned analyses were executed and reported for all primary and secondary outcomes. |
| Groups similar at baseline (selection bias) |
Low risk |
Both treatment groups were balanced on all relevant characteristics at baseline. |
| Co‐interventions avoided or similar (performance bias) |
Low risk |
No opportunity for co‐interventions because the trial took place in a single session |
| Compliance acceptable in all groups (performance bias) |
Low risk |
Compliance was 100% because the trial took place in a single session. |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. Outcome assessments were identical for all patients, regardless of treatment group; 2. Oswestry Disability Index (for function), and Visual Analogue Scale (for pain) are all well‐validated tools in the low back pain context. |
| Other bias |
Low risk |
Appeared free from other sources of bias |
