| Study characteristics |
| Methods |
Study design: RCT (NCT02371837)
Setting: Spain, general population
Exercise groups: 2
Comparison groups: 1 |
| Participants |
Number of participants: 102 (E1 = 34, E2 = 34, C1 = 34)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: No participants
Mean age (years): 36
Sex (female): 64% |
| Interventions |
Exercise Group 1 (E1): Equipment‐based pilates; type = Pilates; duration = 12 weeks; dose = high; design = standardised; delivery = group; additional intervention = none
Exercise Group 2 (E2): Mat‐based pilates; type = Pilates; duration = 12 weeks; dose = high; design = standardised; delivery = group; additional intervention = none
Comparison Group 1 (C1): Usual care/no treatment (control group: no intervention) |
| Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Roland‐Morris Disability Questionnaire)
Follow‐up time periods available for syntheses: 12 weeks (short) |
| Notes |
Conflicts of interest: None to declare
Funding source: Not reported
Other: Information modified for author contact |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated table of random numbers |
| Allocation concealment (selection bias) |
Low risk |
Allocations were sealed in opaque and consecutively numbered envelopes kept in a locked location; opened in sequence by an independent administrator not involved in the study. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Patients were not blinded; 2. Pilates protocols were explicit, unlikely to be accessible outside of study. |
| 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. Pilates interventions were distinct, one with equipment one without, unlikely to have deviations; control group had minimal contact with physiotherapists. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
1. Outcome assessors for pain 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 an exercise versus no treatment study likely to be altered by knowledge of intervention assignment. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. Dropout rate was very small, only 4%. |
| Participants analysed in group allocated (attrition bias) |
Low risk |
1. Appeared that all patients were analysed according to the allocation to which they were randomised |
| Selective reporting (reporting bias) |
Low risk |
1. No linked protocol or statistical analysis plan found: within this publication, all analyses and outcomes were fully reported; no obvious omissions. |
| Groups similar at baseline (selection bias) |
Low risk |
Groups were similar on all relevant characteristics at baseline, except study did not measure duration of symptoms. |
| Co‐interventions avoided or similar (performance bias) |
Low risk |
No information reported on co‐interventions |
| Compliance acceptable in all groups (performance bias) |
High risk |
No information reported on compliance, adherence or attendance, despite the study having measured it. |
| 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. Visual Analogue Scale (for pain) and Roland‐Morris Disability Questionnaire (for function) are well‐validated tools in the low back pain context. |
| Other bias |
Low risk |
Appeared free from other sources of bias |
