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

Isomeri 1993.

Study characteristics
Methods Design: parallel
Duration: 12 weeks
Assessment: baseline and post‐intervention
Country: Finland
Participants Pain condition: fibromyalgia
Population: people with fibromyalgia
Minimum pain intensity: no
Inclusion criteria
  • Patients fulfilling the diagnostic criteria of Yunus 1983 for primary fibromyalgic syndrome


Exclusion criteria
  • Other diseases causing pain


Total participants randomised: 51
Age in years (mean): 43.7
Gender: 39/51 were female
Pain duration in years (mean): 7.9
Interventions Physiotherapy and amitriptyline 25 mg
  • n = 17

  • Combined intervention: physiotherapy + TCA

  • Fixed dose of 25 mg

  • Conventional physiotherapy consisting of light muscle stretching exercises only


Physical fitness training
  • n = 17

  • Cardiovascular fitness training


Physical fitness training and amitriptyline 25 mg
  • n = 17

  • Combined intervention: physical fitness training + TCA

  • Physical fitness training of increasing strenuousness and amitriptyline 25 mg in the evenings

  • Fixed dose

Outcomes Withdrawal
Missing data methods NR
Funding source Non‐pharmaceutical: supported by grants from the Rheumatism Research Foundation
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation methods NR
Allocation concealment (selection bias) Unclear risk Allocation procedures NR
Blinding of participants and personnel (performance bias)
All outcomes High risk Not able to be double‐blinded due to nature of interventions. Doesn't mention sham dosing or placebo for group not receiving amitriptyline
Blinding of outcome assessment (detection bias)
All outcomes High risk Self‐reported outcomes from unblinded participants
Incomplete outcome data (attrition bias)
All outcomes High risk Completer‐only analysis, no information given about withdrawal reasons
Attrition
Total: 6/51 (11.8%)
Physiotherapy + amitriptyline 25 mg: 1/17 (5.9%)
Physical fitness training: 2/17 (11.8%)
Physical fitness training + amitriptyline 25 mg: 3/17 (17.7%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified.