Natour 2014.
| Methods | Randomised, controlled clinical trial | |
| Participants | 60 patients were selected Settings: not reported Country: Brazil Inclusion criteria: diagnosis of chronic low back pain (defined as pain between the lower rib cage and gluteal folds for more than 12 months); non‐specific low back pain characterised by the absence of signs of a serious underlying condition (such as cancer, infection or cauda equina syndrome), spinal stenosis or radiculopathy, or another specific spinal cause (such as vertebral compression fracture or ankylosing spondylitis), pain that becomes accentuated with physical effort and is relieved with rest; male or female; aged 18 to 50 years; pain between four and seven on a 10 cm visual analogue scale; and agreement to participate in the study Exclusion criteria: diagnosis of low back pain due to other causes; fibromyalgia; prior spine surgery; lawsuit; having initiated or changed regular physical activity in the previous 3 months; body mass index > 30; and having undergone treatment with physical therapy or acupuncture in the previous 3 months |
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| Interventions | 1. Experimental group: patients maintained medical treatment with the use of a non‐steroidal anti‐inflammatory drug and underwent treatment with the Pilates method 2. Control group: patients continued medical treatment with the use of a non‐steroidal anti‐inflammatory drug and did not undergo any other intervention | |
| Outcomes | 1. Pain: measured with the patient indicating his/her current level of pain by marking a point on a 10 cm VAS
2. Function: measured with the Roland‐Morris questionnaire
3. Quality of life: measured with the SF‐36 4. Satisfaction with treatment: measured with a Likert scale used to determine patient satisfaction with the treatment (patients answered the question 'How do you feel today in comparison with your last evaluation?', for which the options were 'much better', 'a little better', 'the same', 'a little worse' and 'much worse') 5. Flexibility: measured with a sit and reach test, which is the maximal distance achieved in the Wells bench 6. Non‐steroidal anti‐inflammatory drug intake; the sodium diclofenac intake was recorded on a chart supplied to each patient |
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| Notes | The authors declare that there is no conflict of interest This study was funded by grants provided by Fundacao Amparo a Pesquisa do Estado de Sao Paulo (2007/53423‐5) Adverse events: not evaluated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Patients were randomised using an electronically generated randomisation table" |
| Allocation concealment (selection bias) | Low risk | "Sealed, opaque envelopes were used to ensure the confidentiality of the assignment. The envelopes were stored in a locked cupboard and only opened after the initial evaluation by an individual who did not participate in the study." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | "One limitation of this study is that the treatment provider and participants could not be blinded to the interventions." |
| Blinding of personnel/care providers (performance bias) All outcomes | High risk | "One limitation of this study is that the treatment provider and participants could not be blinded to the interventions." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "An examiner blind to the assignment of the patients performed all evaluations." |
| 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 | "Data for all patients were evaluated with 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 the Table 1 |
| Co‐interventions (performance bias) | Unclear risk | Not mentioned |
| Compliance (performance bias) | Low risk | Compliance was acceptable, based on the description for both groups |
| Timing of outcome assessments (detection bias) | Low risk | All important outcome assessments for both groups were measured at the same time |