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

Rani 1996.

Study characteristics
Methods Design: parallel
Duration: 4 weeks
Assessment: baseline, week 1, week 2, week 3, post‐intervention
Country: India
Participants Pain condition: chronic pain syndrome
Population: 27 presented with low back pain, 16 with OA, 8 with fibromyalgia, and 8 with RA
Minimum pain intensity: ≥ 60 on 0‐100 VAS
Inclusion criteria
  • People with chronic pain syndrome

  • Pain intensity ≥ 60 on 0‐100 VAS

  • Poor response to NSAIDs after 1 month


Exclusion criteria
  • Severe physical health comorbidities


Total participants randomised: 59
Age in years (mean, SD): 40
Gender: 36/59 were female
Pain duration in months (mean): 25.3
Interventions Placebo
  • n = 18

  • Inert

  • Identical appearance


Amitriptyline 25 mg
  • n = 20

  • TCA

  • Fixed dose


Fluoxetine 20 mg
  • n = 21

  • SSRI

  • Fixed dose

Outcomes Pain intensity
Withdrawal
Missing data methods Unclear
Funding source Pharmaceutical: supported by Natco Pharma Limited, India
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation methods not specified
Allocation concealment (selection bias) Unclear risk Allocation procedures not specified
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, identical study drugs with 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 No mention of missing data handling/impute methods, it seems like no participants dropped out but this is unclear
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified