Schenk 2012.
Study characteristics | ||
Methods |
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Participants |
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Interventions |
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Outcomes |
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Notes | Both groups were treated by physical therapist with certification in McKenzie method | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Participants were randomly assigned via a computerized random number generator". |
Allocation concealment (selection bias) | High risk | The author was contacted and reported that the process of allocation concealment was carried out by alternating the assigned interventions. |
Blinding (performance bias and detection bias) All outcomes | High risk | The index and control groups are distinguishable for the patients. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The index and control groups are distinguishable for the care providers. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The primary outcomes are self‐reported outcomes, in which the patient (unblinded) is the outcome assessor. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The percentage of withdrawals did not exceed 20% in the short term follow‐up. |
Intention to treat analysis | High risk | Participants who crossed‐over were not included in the analysis. |
Selective reporting (reporting bias) | Low risk | All of the study's pre‐specified outcomes in the protocol have been reported. |
Group similarity at baseline | Low risk | Demographic and clinical characteristics were similar between groups. |
Co‐interventions | Low risk | The author was contacted and reported that there were no co‐interventions. |
Compliance | Low risk | "All subjects, regardless of enrolment, performed 10 repetitions of lumbar movements. Participants in the MDT group performed the repetitive movements in the DP on an hourly basis throughout the day, from session 3 until discharge as the home exercise program, a standard part of a MDT intervention. Those in the STM group performed lumbar flexion and extension in quadruped (‘cat and camel’) for 10 repetitions hourly throughout the day, from session 3 until discharge". |
Timing of outcome assessment | Low risk | All participants were evaluated at the same time. |
Other bias | High risk | Participants could cross‐over to the alternative at the week 2 visit if they failed to improve with the randomly assigned treatment. Participants were included if they met at least three of five of the selection criteria in clinical prediction rules. However, only those who met four of these criteria were retained for analysis. |
FABQ: Fear‐Avoidance Beliefs Questionnaire LBP: Low back pain MDT: Mechanical Diagnosis and Therapy NRS: Numerical Pain Rating Scale ODI: Oswestry Disability Index RMDQ: Roland Morris Disability Questionnaire STM: spinal manipulative therapy VAS: Visual Analogue Scale