Yamauchi 2008.
Study characteristics | ||
Methods | Randomised, double‐blind, placebo control | |
Participants | N = 202, about 30% women | |
Interventions |
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Outcomes | Pain intensity (VAS) at rest and during movement at 1, 6, 12, 24, 36, 48 h and 3, 6 and 10 days after surgery. Analgesic consumption. AEs | |
Surgery type | Posterior cervical spine and lumbar spine surgery | |
Group numbers after end of study (treatment/control) | 133/67 | |
Age of patient population (treatment/control) | 60.2 ± 16.9 57 ± 17.3 |
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Notes | The study consists of cervical and lumbar surgery participants with 2 different interventions and corresponding control groups. These treatment arms (4 treatment arms and corresponding control groups) were analysed separately. No mention of sponsorship or funding | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation by shuffling envelopes |
Allocation concealment (selection bias) | Low risk | Allocation concealment in envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Mentioned "double‐blind" but not described |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1% was withdrawn |
Selective reporting (reporting bias) | Low risk | Predefined outcomes reported |
Size | High risk | 22, 23 and 23 participants in the cervical surgery groups. 42, 46 and 44 participants in the lumbar surgery groups |