Gladwell 2006.
| Methods | Single‐blind randomised controlled trial | |
| Participants | 49 participants who had had non‐specific chronic low back pain for more than 12 weeks (located below the scapulae and above the cleft of the buttocks) Settings: individuals living within the Colchester region were offered the chance to participate in this study via posters and letters given to local doctors' clinics and via e‐mailed information to staff and students at the local university Country: United Kingdom Inclusion criteria: chronic low back pain for at least 12 weeks not attributable to any specific pathology (see exclusions) located below the scapulae and above the cleft of the buttocks. Aged between 18 and 60 years old. Patient able to travel independently. Patient is otherwise medically fit to perform physical training and able to consent and understand what the study entails Exclusion criteria: back pain attributed to any specific pathology: e.g. disc herniation, tumour, infection or fracture, osteoporosis, structural deformity, inflammatory disorder, radicular syndrome or cauda equina. Patient is unable to walk without a walking aid. Patient already involved in regular Pilates classes. Constant or severe back pain judged on clinical grounds due to nerve root irritation. Major surgery within the past year |
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| Interventions | 1. Pilates group: performed 6 1‐hour classes of Pilates exercise (maximum class size = 12), 1 class per week. The Pilates exercise programme was taught by a certified Pilates Institute Instructor. In the first class, the basic principles of Pilates were explained and a handout was provided to participants for home reading. Basic principles were reiterated at the beginning of every class throughout the intervention period with an increasing portfolio of relevant Pilates techniques. In each 1‐hour class, an educational aspect was provided followed by specific modified Pilates exercises. Educational aspects included posture check (including neutral spine and pelvis), recruitment of "core muscles" and encouragement not to substitute from global muscles; all aspects were completed during controlled breathing. The exercises were "cued" by appropriate verbal instructions given by the instructor. All exercises started at the base level and were progressed by incorporating limb movement, when participants were able to maintain control of the spine. Additional exercises were also added during each session. The exercises taught within a class were also repeated individually during 2 30‐minute sessions each week performed at home without supervision. No progression of exercises was made during home sessions. Compliance with home‐based exercises was recorded in a diary 2. Control group: continued with their normal activities and pain relief |
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| Outcomes | 1. Pain: Roland Morris pain rating visual analogue scale (RMVAS) 2. Disability: the Oswestry Low‐Back Pain Disability Questionnaire (OSWDQ) |
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| Notes | No statement about conflicts of interest or funding provided 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 | 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 |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No mention of any attempts to blind the participants |
| 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 | "...a functional assessment were performed by an assessor blinded to the allocation of individuals to the two groups" |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Dropouts exceeded 20% |
| Intention‐to‐treat analysis | Unclear risk | No information about intention‐to‐treat analysis |
| 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 Table 3 |
| Co‐interventions (performance bias) | Unclear risk | Not mentioned |
| Compliance (performance bias) | Unclear risk | There was not enough data for the control group |
| Timing of outcome assessments (detection bias) | Low risk | All important outcome assessments for both groups were measured at the same time |