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 |
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Interventions | NSAID (i): piroxicam 20 mg/day, 6 weeks (N = 14) NSAID (ii): indometacin 75 mg/day, 6 weeks (N = 14) |
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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 |
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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 |