| Study characteristics |
| Methods |
Study design: RCT (NCT02371837)
Setting: Spain, general population
Exercise groups: 1
Comparison groups: 1 |
| Participants |
Number of participants: 64 (E1 = 32, C1 = 32)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: No participants
Mean age (years): 37
Sex (female): 66% |
| Interventions |
Exercise Group 1 (E1): Pilates training; type = Pilates; duration = 12 weeks; dose = high; design = partially individualised; delivery = group; additional intervention = none
Comparison Group 1 (C1): Other conservative treatment (education) |
| 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: No funding received
Other: None |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation performed by an independent researcher in a 1:1 ratio |
| Allocation concealment (selection bias) |
Low risk |
Treatment allocation was concealed; randomisation was performed by an independent researcher and allocation was placed in sealed, opaque envelopes. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Patients could not be blinded to intervention due to the nature of the treatment groups; 2. Lack of patient blinding was unlikely to have led to deviations from intended intervention because patients had little control over intervention; cross‐over between groups was unlikely. |
| 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. Lack of care provider blinding likely did not deviate intended interventions because providers only interacted with one treatment group; little contact with control outside outcome assessments |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
1. Outcome assessors were patients, who could not be blinded due to the nature of the treatment groups; 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 3% (2/64). |
| Participants analysed in group allocated (attrition bias) |
Low risk |
1. Not explicitly stated, however, no indication otherwise; numbers matched intention‐to‐treat analysis. |
| Selective reporting (reporting bias) |
Low risk |
1. No linked protocol or statistical analysis plan found: within this publication all outcomes and analyses fully reported; no obvious omissions |
| Groups similar at baseline (selection bias) |
Low risk |
Both treatment groups were similar at baseline on all relevant characteristics, except the exercise group had a slightly higher mean body mass index than control; duration of symptoms was not reported. |
| Co‐interventions avoided or similar (performance bias) |
High risk |
No information on co‐intervention use was reported in this study. |
| Compliance acceptable in all groups (performance bias) |
Low risk |
Little explicit reporting of compliance, except for this quote (from discussion): "participants showed high adherence to treatment". |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. All patients were assessed identically, regardless of treatment group; 2. Roland‐Morris Disability Questionnaire (for disability) and Visual Analogue Scale (for pain) are well‐validated tools in the low back pain context. |
| Other bias |
Low risk |
Appeared free from other sources of bias |
