Mahmoud 2021.
Study characteristics | ||
Methods | Design: parallel Duration: 16 weeks Assessment: baseline and post‐intervention Country: Egypt |
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Participants | Pain condition: neck pain Population: adults with chronic neck pain Minimum pain intensity: no Inclusion criteria
Exclusion criteria
Total participants randomised: 80 Age in years (mean): 46.6 Gender: 52/80 were female Pain duration in years (mean, SD): NR |
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Interventions | Amitripyline 5 mg
Amitripyline 10 mg
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Outcomes | Pain intensity Withdrawal |
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Missing data methods | Completer‐only analysis | |
Funding source | Non‐pharmaceutical: "This work was funded in part by Fayoum University Hospitals (Fayoum, Egypt) and by the authors’ personal resources." | |
Conflicts of interest | The authors declare that there are no conflicts of interest regarding the publication of this paper. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Simple randomisation using a randomisation table created by a computer software program |
Allocation concealment (selection bias) | Low risk | Participants were allocated using sealed opaque envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind with identical study drugs |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes from blinded participants |
Incomplete outcome data (attrition bias) All outcomes | High risk | Completer analysis only Attrition Total: 10/80 (12.5%) Amitriptyline 5 mg: 5/40 (12.5%) Amitriptyline 10 mg: 5/40 (12.5%) |
Selective reporting (reporting bias) | Unclear risk | Outcomes published match trial registry though retrospectively registered |
Other bias | Unclear risk | Confusing reporting of primary outcome. In the text, it says that neck pain (as measured by the Neck Pain Driving Index) decreased by 71.9% ± 13.4% in the 10 mg group, which was greater than the decrease in the 5 mg group (47.3% ± 17.3%). However in the figure it says that the decreases were 48.3% for 5 mg and 68.2% for 10 mg. |