Aluko 2013.
Study characteristics | ||
Methods |
Study design: RCT Recruitment period: July 2008–June 2010 Recruitment mode: participants were recruited from within a primary care musculoskeletal physiotherapy service provider within the London borough of Hillingdon. This unit provided a central base of treatment for people across the borough who were referred by their GP. Statistical analysis: outcome data analysed using multiple regression analysis where the baseline value was included as a covariate for each analysis. All data were skewed and log‐transformed, results are presented as the ratio geometric means with 95% CI. An ITT analysis was used with missing data replaced with the LOCF for incomplete data sets. Sample size calculation: in the absence of a known published clinically significant difference for the major outcome measure of mean trunk sagittal acceleration resulting from CSEs, it was not possible to use a standardised calculation to determine the appropriate sample size. The sample size was therefore derived from a similar study previously published. |
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Participants |
Sample size: total: 33; EG1: 16; EG2: 17 Setting: primary care musculoskeletal physiotherapy service provider Country: UK Baseline characteristics
Duration LBP: ≤ 6 weeks; 22 (67%) of participants had a previous episode of acute NSLBP Inclusion criteria
Exclusion criteria
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Interventions |
EG1: core stability class + stabilisation exercises
EG2: core stability class
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Outcomes |
Note: outcomes not designated as major or minor outcomes Pain: VAS (0–100)
Functional status: RMDQ
Other: trunk sagittal acceleration Adverse events: not reported |
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Notes |
Authors' results and conclusions: the difference in pain and disability between the groups was statistically and clinically nonsignificant Funding: no funding sources reported Declaration of interest: no conflicts of interest reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The participants were randomly allocated"; "The randomisation was done by a colleague independent and blind to the study using concealed envelopes within which the group description was randomly placed within them." |
Allocation concealment (selection bias) | Low risk | Quote: "The randomisation was done by a colleague independent and blind to the study using concealed envelopes." |
Blinding All outcomes ‐ Participants | High risk | No mention of attempts to blind participants or their perceptions of the potential effectiveness of the different interventions. |
Blinding All outcomes ‐ Healthcare providers | High risk | No mention of any attempts to blind care providers. |
Blinding All outcomes ‐ outcome assessors | High risk | The outcome measures were self‐reported and participants were unblinded. |
Influence of co‐interventions | Unclear risk | Personal communication: participants were requested not to seek additional treatment and the treating physiotherapists did not offer additional treatment. However, the study did not record whether participants sought other therapies. |
Group similarity at baseline | Unclear risk | Study measured age, sex, height, weight. There were no differences between groups. No other baseline measures were reported. |
Compliance | High risk | Personal communication: compliance was acceptable compared to clinical practice: 7/16 participants did no exercises; 4 participants did exercises some days (6, 7, 17, or 23 days); 5 participants did exercises all or most days. |
Timing of outcome assessments | Low risk | Measurements at 3 weeks, 6 weeks, and 3 months of follow‐up. |
Incomplete outcome data (attrition bias) Dropouts – all outcomes | High risk | Personal communication: flowchart with the number of dropouts: 11 in the exercise group, 11 in the control group. |
Intention‐to‐treat‐analysis | Low risk | Quote: "An intention‐to‐treat analysis was used with missing data replaced with the Last Observation Carried Forward for incomplete data sets." The number of dropouts does not differ between groups. |
Selective reporting (reporting bias) | Low risk | Pain intensity and function reported; no published protocol available. |
Other bias | Unclear risk | No funding sources were reported. No official disclosure regarding potential conflicts of interest. |