| Study characteristics |
| Methods |
Study design: RCT (NCT02241538)
Setting: Brazil, general population
Exercise groups: 3
Comparison groups: 1 |
| Participants |
Number of participants: 296 (E1 = 74, E2 = 74, E3 = 74, C1 = 74)
Chronic LBP duration: 45.75 months (long)
Neurological/radicular symptoms: Not specified
Mean age (years): 48
Sex (female): 76% |
| Interventions |
Exercise Group 1 (E1): Pilates: 3 sessions of Pilates per week, including ground exercises (with or without accessories, such as ball, magic circle and toning ball) and apparatus exercises (Barrel, Cadillac, Chair and Reformer—Metalife, Santa Catarina, Brazil) for 6 weeks, warm‐up (breathing and mobility exercises) and cool‐down (relaxation exercises and massage with a ball); type = Pilates; duration = 6 weeks; dose = low; design = individualised; delivery = individual; additional intervention = advice/education & manual therapy
Exercise Group 2 (E2): Pilates: 2 sessions of Pilates per week, ground exercises (with or without accessories, such as ball, magic circle and toning ball) and apparatus exercises (Barrel, Cadillac, Chair and Reformer—Metalife, Santa Catarina, Brazil) for 6 weeks, warm‐up and cool‐down; type = Pilates; duration = 6 weeks; dose = low; design = individualised; delivery = individual; additional intervention = advice/education & manual therapy
Exercise Group 3 (E3): Pilates once per week: ground exercises (with or without accessories, such as ball, magic circle and toning ball) and apparatus exercises (Barrel, Cadillac, Chair and Reformer—Metalife, Santa Catarina, Brazil) for 6 weeks, warm‐up and cool‐down; type = Pilates; duration = 6 weeks; dose = low; design = individualised; delivery = individual; additional intervention = advice/education & manual therapy
Comparison Group 1 (C1): Other conservative treatment (education) |
| Outcomes |
Core outcomes reported: Pain (Numerical Rating Scale); function (Roland‐Morris Disability Questionnaire); Global Perceived Health or Recovery (Global Perceived Health or Recovery (Global Perceived Effect scale (−5 to +5))
Follow‐up time periods available for syntheses: 6 weeks (short); 26 weeks (moderate); 52 weeks (long) |
| Notes |
Conflicts of interest: GCM is an instructor of NeoPilates courses.
Funding source: São Paulo Research Foundation (process: 2013/26321‐8 and 2016/07915‐2)
Other: Information modified for author contact |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Random number table |
| Allocation concealment (selection bias) |
Low risk |
Treatment allocation was concealed through sealed opaque envelopes sequentially numbered by a researcher, blinded for patient characteristics. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Very difficult to blind the patient to allocation, due to the differences between control and experimental groups; 2. Unlikely that lack of patient blinding led to deviations; intervention required trained personnel; patients explicitly told not to start co‐interventions; supposedly monitored but no report |
| 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 meaningful deviations; they were quite clearly prescribed; advice control group versus Pilates; personnel had no contact with the control group. |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
1. Outcome assessors for pain and disability were patients, and so were not likely to have been blinded to allocation, due to the distinct nature of each treatment group; 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; varying levels of intensity likely came with expectations of better care. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. Follow‐up at 6 weeks for clinical outcomes was 94%. |
| Participants analysed in group allocated (attrition bias) |
Low risk |
1. All patients were explicitly reported to have been analysed by the intention‐to‐treat principle. |
| Selective reporting (reporting bias) |
Low risk |
1. Protocol NCT02241538: all outcomes analysed and reported as per protocol. |
| Groups similar at baseline (selection bias) |
Low risk |
No significant differences between groups on age, sex, body mass index, duration, marital status, education, previous receipt of treatment, pain, disability or other outcomes at baseline |
| Co‐interventions avoided or similar (performance bias) |
High risk |
Co‐interventions were discouraged in all groups; patients were allowed to use their usual medication, and there were significant differences in use between Pilates and control. |
| Compliance acceptable in all groups (performance bias) |
Low risk |
On average 84% of sessions were attended. |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. All outcome assessments were performed with the same tools and at the same time across all treatment groups; 2. Numeric Pain Rating Scale and Roland‐Morris Disability Questionnaire (for disability) are well‐validated tools in the context of low back pain. |
| Other bias |
Low risk |
Appeared free from other sources of bias |
