Skip to main content
. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

Ginsberg 1996.

Study characteristics
Methods Design: parallel
Duration: 8 weeks
Assessment: baseline, 4 weeks (halfway point), post‐intervention
Country: Belgium
Participants Pain condition: fibromyalgia
Population: people with fibromyalgia
Minimum pain intensity: no
Inclusion criteria
  • Fibromyalgia meeting the ACR 1990 criteria

  • History of widespread pain for at least 3 months

  • Pain in at least 11 of 18 specific tender points


Exclusion criteria
  • Physical health comorbidities


Total participants randomised: 51
Age in years (mean): 46
Gender: 38/51 were female
Pain duration in years (mean): 3.2
Interventions Placebo
  • n = 22 (completers)

  • Inert

  • Identical appearance and matched dosing schedule


Amitriptyline 25 mg
  • n = 24 (completers)

  • TCA

  • Fixed dose with no titration

Outcomes Pain intensity
Sleep
AEs
Withdrawal
Missing data methods ITT but no information regarding imputation methods given
Funding source NR
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information given, just says patients were "randomised"
Allocation concealment (selection bias) Unclear risk Allocation procedures not specified
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Double‐blind, identical study drugs and matched dosing
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes from blinded participants
Incomplete outcome data (attrition bias)
All outcomes Unclear risk State ITT but no imputation methods reported
Attrition
Total: 6/51 (11.8%)
Placebo: 3/25 (12.0%)
Amitriptyline 25 mg: 3/26 (11.5%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias identified