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. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

Maarrawi 2018.

Study characteristics
Methods Design: parallel
Duration: 8 weeks
Assessment: baseline and post‐intervention
Country: Lebanon
Participants Pain condition: chronic neck pain
Population: people with chronic neck pain
Minimum pain intensity: no
Inclusion criteria
  • Chronic neck pain for > 15 days/month during at least 3 consecutive months


Exclusion criteria
  • Physical and mental health comorbidities


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)
Interventions Placebo
  • n = 166

  • Inert

  • Identical appearance and matched dosing


Amitriptyline 5 mg
  • n = 166

  • TCA

  • Fixed dose, no titration

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