Study characteristics |
Methods |
Study design: RCT (ACTRN12609000536268)
Setting: Australia, general population
Exercise groups: 2
Comparison groups: 0 |
Participants |
Number of participants: 87 (E1 = 44, E2 = 43)
Chronic LBP duration: Not specified (moderate)
Neurological/radicular symptoms: Some participants
Mean age (years): 49
Sex (female): 55% |
Interventions |
Exercise Group 1 (E1): Series of Pilates exercises performed on the reformer and trapeze equipment, directional‐specific; type = Pilates; duration = 6 weeks; dose = low; design = individualised; delivery = group; additional intervention = none
Exercise Group 2 (E2): Exercise including stationary bike, leg stretches, upper body weights, theraband, Swiss ball, and floor exercises: multidirectional; type = mixed; duration = 6 weeks; dose = low; design = standardised; delivery = group; additional intervention = none |
Outcomes |
Core outcomes reported: Pain (Quebec Back Pain Disability Scale); function (Quebec Back Pain Disability Scale); HRQoL (36‐Item Short Form Survey); Global Perceived Health or Recovery (Global Perceived Health or Recovery (Global Perceived Effect scale))
Follow‐up time periods available for syntheses: 6 weeks (short); 13 weeks (moderate); 104 weeks (long) |
Notes |
Conflicts of interest: Henry Wajswelner works at a physiotherapy and Pilates clinic that uses clinical Pilates exercises to treat patients. He also teaches clinical Pilates to other physiotherapists.
Funding source: Mr. Craig Phillips of DMA Clinical Pilates Physiotherapy in South Yarra, Melbourne, Victoria, Australia; Mr. Marcus Pain of Back in Motion Physiotherapy in Brunswick, Melbourne, Victoria, Australia
Other: None |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
After baseline assessment, participants were randomly allocated in permuted blocks of six and eight, stratified by age. |
Allocation concealment (selection bias) |
Low risk |
Allocation was sealed in opaque and consecutively numbered envelopes held centrally. |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Assumed not possible |
Blinding of care provider (performance bias) |
High risk |
Assumed not possible |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Several self‐report questionnaire measures were taken including those recommended in the European Guidelines on Chronic Low Back Pain. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Eighty‐three participants (96%) completed the six‐week intervention, 67 (77%) completed the 12‐week follow‐up, and 60 (69%) completed the 24‐week follow‐up. |
Participants analysed in group allocated (attrition bias) |
Low risk |
The primary analysis was by intention‐to‐treat and was performed in a blinded manner using the Statistical Package for the Social Sciences. |
Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
Groups similar at baseline (selection bias) |
Low risk |
The groups were similar at baseline for demographic and clinical characteristics (Table 1). |
Co‐interventions avoided or similar (performance bias) |
Low risk |
There were few reported co‐interventions. |
Compliance acceptable in all groups (performance bias) |
Low risk |
Thirteen participants (seven from the clinical Pilates group and six from the general exercise group) failed to complete all 12 exercise class sessions. |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |