Urquhart 2018.
Study characteristics | ||
Methods | Design: parallel Duration: 24 weeks Assessment: baseline, 3 months, post‐intervention Country: Australia |
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Participants | Pain condition: low back pain Population: people aged 18‐75 with chronic non‐specific low back pain Minimum pain intensity: no Inclusion criteria
Exclusion criteria
Total participants randomised: 146 Age in years (mean, SD): 54.8 (13.7) Gender: 53/146 were female Pain duration in years (mean): 14.3 |
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Interventions | Placebo (benzotropine mesylate 1 mg)
Amitriptyline 25 mg
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Outcomes | Pain intensity Physical function Mood Quality of life AEs Withdrawal |
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Missing data methods | ITT using multiple imputation with chained equations | |
Funding source | Non‐pharmaceutical: "This work was supported by theNational Health and Medical Research Council(NHMRC, Australia, ID 1024401). Drs Urquhart, Wluka, and Wang are recipients of NHMRC Career Development Fellowships (Clinical Level 1 No.1011975; Clinical Level 2 No. 1063574; Clinical Level1 No. 1065464, respectively)" | |
Conflicts of interest | None reported | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomisation was based on computer‐generated random numbers prepared by a statistician who had no involvement in trial conduct." |
Allocation concealment (selection bias) | Low risk | "The use of a central allocation that involved pharmacy‐controlled randomisation ensured that the allocation could not be accessed by research personnel." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, active placebo, identical appearance, matched dosing |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes by blinded participants |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Uses multiple imputation by chained equations, presents comparisons with no multiple imputation Attrition Total: 28/146 (19.2%) Placebo: 15/74 (20.3%) Amitriptyline 25 mg: 13/72 (18.1%) |
Selective reporting (reporting bias) | Low risk | Matches protocol. Explains why Descriptor Differential Scale is NR (participants had difficulty filling it in) |
Other bias | Low risk | No other sources of bias |