Maarrawi 2018.
Study characteristics | ||
Methods | Design: parallel Duration: 8 weeks Assessment: baseline and post‐intervention Country: Lebanon |
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Participants | Pain condition: chronic neck pain Population: people with chronic neck pain Minimum pain intensity: no Inclusion criteria
Exclusion criteria
Total participants randomised: 332 Age in years (mean, SD): 44.23 (11.39) Gender: 190/332 were female Pain duration in years (mean, SD): 15.4 (4.86) |
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Interventions | Placebo
Amitriptyline 5 mg
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Outcomes | Pain intensity | |
Missing data methods | Completer‐only analysis | |
Funding source | Non‐pharmaceutical: "This study was supported by the Council of Research of the Saint Joseph University of Beirut – Lebanon (FM201)" | |
Conflicts of interest | No conflicts of interest | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised via the block randomisation method, computer‐generated via www.randomization.com) |
Allocation concealment (selection bias) | Low risk | Randomisation was centralised by a staff nurse (who had never seen the patient) not otherwise involved in the study and noted the group of each participant next to the number assigned to him. The same staff nurse delivered the corresponding medication to each patient. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, study drugs were identical with matched dosing schedule |
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‐only analysis. Withdrawal rate rate was ~17% Attrition Total: 58/332 (17.5%) Placebo: 25/166 (15.1%) Amitriptyline 5 mg: 33/166 (19.9%) |
Selective reporting (reporting bias) | Low risk | All outcomes match up with those prospectively registered on clinicaltrials.gov |
Other bias | Unclear risk | Unclear reporting in the publication, especially in relation to sample size and withdrawal |