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

Mahmoud 2021.

Study characteristics
Methods Design: parallel
Duration: 16 weeks
Assessment: baseline and post‐intervention
Country: Egypt
Participants Pain condition: neck pain
Population: adults with chronic neck pain
Minimum pain intensity: no
Inclusion criteria
  • Chronic neck pain for > 15 days per month and lasting at least 3 months


Exclusion criteria
  • Physical and mental health comorbidities


Total participants randomised: 80
Age in years (mean): 46.6
Gender: 52/80 were female
Pain duration in years (mean, SD): NR
Interventions Amitripyline 5 mg
  • n = 40

  • TCA

  • Fixed dose


Amitripyline 10 mg
  • n = 40

  • TCA

  • Fixed dose

Outcomes Pain intensity
Withdrawal
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.