Rani 1996.
Study characteristics | ||
Methods | Design: parallel Duration: 4 weeks Assessment: baseline, week 1, week 2, week 3, post‐intervention Country: India |
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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
Exclusion criteria
Total participants randomised: 59 Age in years (mean, SD): 40 Gender: 36/59 were female Pain duration in months (mean): 25.3 |
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Interventions | Placebo
Amitriptyline 25 mg
Fluoxetine 20 mg
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Outcomes | Pain intensity Withdrawal |
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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 |