| Study characteristics |
| Methods |
Study design: RCT
Setting: Italy, general population
Exercise groups: 1
Comparison groups: 1 |
| Participants |
Number of participants: 38 (E1 = 19, C1 = 19)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: No participants
Mean age (years): 41
Sex (female): Not reported |
| Interventions |
Exercise Group 1 (E1): Pilates: floor‐based Pilates exercise intervention (2 levels of difficulty, basic and intermediate); type = Pilates; duration = 14 weeks; dose = high; design = partially individualised; delivery = group; additional intervention = none
Comparison Group 1 (C1): Usual care/no treatment (control group: no intervention) |
| Outcomes |
Core outcomes reported: Function (Oswestry Disability Index)
Follow‐up time periods available for syntheses: 14 weeks (moderate) |
| 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 |
Computer‐generated random number sequence |
| Allocation concealment (selection bias) |
Low risk |
Allocation sequence was computer‐generated, with group allocation conducted by a research assistant who did not participate in any component of the study. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Patients could not be blinded due to the nature of the interventions; 2. Unlikely that lack of patient blinding led to deviations from intended intervention; Pilates group required instructor; control group was allowed any usual activities. |
| Blinding of care provider (performance bias) |
Low risk |
1. Care providers could not be blinded due to the nature of the interventions; 2. Unlikely that lack of care provider blinding led to deviations from intended interventions because they only interacted with Pilates group; control group were not followed until outcome assessments. |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
1. For the outcome of interest (disability) the outcome assessor was the participant, who could not be blinded due to the nature of the interventions; 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. No dropouts in this study |
| Participants analysed in group allocated (attrition bias) |
Low risk |
1. Participants were analysed according to their treatment allocation. |
| Selective reporting (reporting bias) |
Low risk |
1. No linked protocol found: only looked at Oswestry but sourced it as comprising of pain and function, so no obvious omissions |
| Groups similar at baseline (selection bias) |
High risk |
At baseline, both groups were similar in age and disability; however, there was no report of sex distribution or duration of symptoms. |
| Co‐interventions avoided or similar (performance bias) |
High risk |
Participants in exercise group did not use nonsteroidal anti‐inflammatory drugs, but control group could if they wished (as well as other social activities and "usual care"). |
| Compliance acceptable in all groups (performance bias) |
Low risk |
Flow diagram stated all patients completed protocol. |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. Outcome measurement took place at the same time points for all participants, and using the same tools (for each outcome); 2. Oswestry Disability Index (for disability) is a well‐validated tool in the context of low back pain. |
| Other bias |
Low risk |
Appeared free from other sources of bias |
