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. 2016 Feb 10;2016(2):CD012087. doi: 10.1002/14651858.CD012087

Videman 1984.

Methods RCT, double‐blind
Participants 28 outpatients, 11 women, 17 men; mean age 45 years
Inclusion: chronic severe low back pain, age 25 to 76 years
Exclusion: pregnant or nursing women, compensation claims, haematological, renal or hepatic disease, pre‐existing radiological evidence of peptic ulcer, intolerance to indomethacin
Interventions NSAID (i): piroxicam 20 mg/day, 6 weeks (N = 14)
NSAID (ii): indometacin 75 mg/day, 6 weeks (N = 14)
Outcomes Change of pain from baseline until 6 weeks: (i) 8.1 (ii) 9.4; no significant difference between groups.
Adverse events: (i) 8 participants (ii) 10 participants
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not mentioned
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding (performance bias and detection bias): All outcomes ‐ Patients 
 All outcomes Low risk Patients were blinded
Blinding (performance bias and detection bias): All outcomes ‐ Care providers 
 All outcomes Low risk Care providers were blinded
Blinding (performance bias and detection bias): All outcomes ‐ Outcome assessors 
 All outcomes Low risk Outcome assessors were blinded
Incomplete outcome data (attrition bias): All outcomes ‐ Drop‐outs 
 All outcomes Low risk Two out of 14 participants in one group were lost to follow‐up.
Incomplete outcome data (attrition bias): All outcomes ‐ ITT analysis 
 All outcomes High risk Complete case analysis
Selective reporting (reporting bias) Unclear risk No study protocol
Similarity of baseline characteristics Unclear risk No baseline characteristics shown
Co‐interventions avoided or similar Low risk Only paracetamol as co‐intervention up to 3000 mg
Compliance acceptable Unclear risk Compliance not mentioned
Timing outcome assessments similar Unclear risk Timing was unclear