Brooks 2012.
| Methods | Randomised controlled trial | |
| Participants | 64 participants with low back pain Settings: not reported Country: Australia Inclusion criteria: men and women aged between 18 and 50 years, with ongoing recurrent LBP (> 12 weeks) located between the costal margins and inferior gluteal folds Exclusion criteria: presence of a severe postural abnormality, pain radiating below the knee, known lumbar disc hernia or fracture, history of back surgery, diagnosed inflammatory joint disease, known severe osteoporosis, known metabolic or neuromuscular disease, or recent (< 3 months) participation in an exercise programme or any form of therapeutic treatment (i.e. manipulation, mobilisation, massage) |
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| Interventions | 1. Specific trunk exercise group (Pilates): the specific programme was based on a Pilates training model, which incorporated skilled contraction techniques, general trunk focused strengthening exercise, whole‐body movements, and stretching of the trunk and hip musculature. It was thought that this model of training best represented the most utilised components of specific trunk exercise rehabilitation programmes for LBP, with a strong focus on the use of skilled contraction techniques (abdominal drawing‐in and abdominal bracing) 2. General exercise group: the general exercise programme was indoor stationary cycle training. Intensity of effort within each component was based on combinations of heart rate training zones (based on percentage of maximal heart rate) and rate of perceived exertion scales All participants were required to attend exercise classes 3 times per week for a total of 8 weeks. Every exercise class was for a duration of 50 to 60 minutes and was supervised, with a participant‐to‐instructor ratio of 10:1. Exercise classes for the 2 groups were administered in different training rooms to minimise the likelihood of contact between participants in the different groups. Instructors for the exercise classes were trained and experienced (minimum 5 years) in a particular intervention only and had no contact with participants or instructors from the different group. Instructors for the exercise groups had no involvement in the recruitment, allocation or assessment of participants in the trial |
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| Outcomes | 1. Self rated disability: Oswestry Disability Index (ODI) 2. Pain: using a 100 mm visual analogue scale (VAS) (left anchor "no pain at all", right anchor "worst pain imaginable") for back pain experienced in the last week, and current back pain (VAS) |
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| Notes | No funding was received in support of this work
"No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript." Adverse events: not evaluated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Review authors' comment: the sequence generation procedure or the method of allocation were not mentioned. The title, abstract and flowchart indicate that it is a RCT |
| Allocation concealment (selection bias) | Unclear risk | Reviewers comment: The sequence generation procedure or the method of allocation were not mentioned. The title, abstract, and flowchart indicate that it is a RCT |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "To control for expectation bias, participants were blinded to the use of different modalities in the trial by being informed that they were volunteering for an exercise trial to investigate how exercise programs work for people with chronic LBP." |
| Blinding of personnel/care providers (performance bias) All outcomes | High risk | No mention of any attempts to blind the care providers |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Self‐report outcome measures and APAs were assessed before and after the 8‐week intervention by a blinded assessor." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The percentage of withdrawals and dropouts was within the acceptable range |
| Intention‐to‐treat analysis | Low risk | "Analysis of self‐report data (ODI and VAS scores) was conducted by “intention to treat” (i.e., all available data from all randomised participants were analysed in the group to which the participant was allocated)." |
| Selective reporting (reporting bias) | Low risk | It was clear that the published report included all expected outcomes |
| Group similarity at baseline (selection bias) | Low risk | Patients did not differ in their baseline characteristics, based on the Table 2 |
| Co‐interventions (performance bias) | Unclear risk | Not mentioned |
| Compliance (performance bias) | Low risk | Compliance was acceptable, based on the reported intensity/dosage, duration, number and frequency for both the intervention and control groups |
| Timing of outcome assessments (detection bias) | Low risk | All important outcomes for both groups were measured at the same time |