Study characteristics |
Methods |
Study design: RCT
Setting: India, healthcare
Exercise groups: 3
Comparison groups: 0 |
Participants |
Number of participants: 45 (E1 = 15, E2 = 15, E3 = 15)
Chronic LBP duration: 9.8 months (moderate)
Neurological/radicular symptoms: No participants
Mean age (years): 35
Sex (female): 33% |
Interventions |
Exercise Group 1 (E1): Pilates: majority of exercises are abdominal or back focussed with warm‐up and cool‐down stretching exercises; type = Pilates; duration = 1.43 weeks; dose = low; design = standardised; delivery = individual; additional intervention = electrotherapy & heat/ice
Exercise Group 2 (E2): Lumbar stabilisation: photographs of all exercises performed focussed on trunk‐strength, warm‐up and cool‐down stretching exercises; type = core strengthening; duration = 1.43 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = electrotherapy & heat/ice
Exercise Group 3 (E3): Lumbar dynamic strengthening focussed on abdominals and lumbar muscles; type = core strengthening; duration = 1.43 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = electrotherapy & heat/ice |
Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Oswestry Disability Index)
Follow‐up time periods available for syntheses: 1.43 weeks (short) |
Notes |
Conflicts of interest: None to declare
Funding source: Not reported
Other: SDs imputed, sufficient data not available for inclusion in meta‐analyses |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Patients were "randomly allocated". |
Allocation concealment (selection bias) |
Low risk |
"Randomly allocated in three groups by envelop method" |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Patients could not be blinded to allocation due to the nature of the treatments; 2. Unlikely that lack of patient blinding caused deviation from intended interventions because patients had no control over the delivery of intervention. |
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 led to deviation from intended intervention because interventions were all quite distinct. |
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 function questionnaires require judgement which could be susceptible to a lack of blinding; 3. No treatment was obviously better than the others; no reason to alter patient response. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. 8 of 44 dropped out, 18%. |
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 outcomes and analyses were fully reported. |
Groups similar at baseline (selection bias) |
High risk |
Pilates group had significantly longer duration of symptoms (1 year longer than other two groups), and almost significantly higher average body mass index (3‐4 points higher). |
Co‐interventions avoided or similar (performance bias) |
High risk |
No information presented about co‐interventions |
Compliance acceptable in all groups (performance bias) |
High risk |
No information on compliance, adherence or attendance presented in this study |
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 Oswestry Disability Index (for function) are well‐validated tools in the low back pain context. |
Other bias |
Low risk |
Appeared free from other sources of bias |