Allegrini 2009.
| Methods | RCT | |
| Participants | 180 participants, 102 women and 78 men; mean age 51 years (range 19 to 78 years) Inclusion: symptomatic lumbar osteoarthritis with daily pain during daily activities defined as a score as 40 mm on a 100 mm VAS Exclusion: participants with known hypersensitivity or allergy to piroxicam or to other NSAIDs; participants using topical medications to the painful region and the use of steroids by any route within 7 days before inclusion |
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| Interventions | NSAID (i): piroxicam patch 14mg/day, 8 consecutive days (N = 60) NSAID (ii): piroxicam 1% cream, 1.4g/day, 8 consecutive days (N = 60) Reference treatment (iii): placebo patch, 8 consecutive days (N = 60) |
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| Outcomes | Responder (reduction of pain score of at least 30%) rate to the administered treatment after 9 days: (i) 60%, (ii) 62% and (iii) 34% Adverse events: (i) 5 participants; (ii) 3 participants; (iii) 3 participants |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer randomized |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding (performance bias and detection bias): All outcomes ‐ Patients All outcomes | Unclear risk | Not mentioned |
| Blinding (performance bias and detection bias): All outcomes ‐ Care providers All outcomes | Unclear risk | Not mentioned |
| Blinding (performance bias and detection bias): All outcomes ‐ Outcome assessors All outcomes | Unclear risk | Not mentioned |
| Incomplete outcome data (attrition bias): All outcomes ‐ Drop‐outs All outcomes | High risk | Each group had a drop out rate of > 20% |
| Incomplete outcome data (attrition bias): All outcomes ‐ ITT analysis All outcomes | Unclear risk | Not mentioned |
| Selective reporting (reporting bias) | Unclear risk | No protocol |
| Similarity of baseline characteristics | Unclear risk | No table with baseline characteristics |
| Co‐interventions avoided or similar | Low risk | Rescue medication: paracetamol, up to 1.5 g per day allowed |
| Compliance acceptable | Low risk | All included participants were compliant |
| Timing outcome assessments similar | Low risk | Timing was similar |