Agrifoglio 1994.
| Methods | RCT; multicentre, single‐blind (observer blind), randomised, parallel group study Randomization procedure not described Follow‐up time: 8 days |
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| Participants |
Population: 100 participants, 40 women, 60 men. Mean age 42.2 years (range 19 to 68) Setting: enrolled from 5 centres in Italy Inclusion criteria: acute lumbago, onset less than 48 hours ago, age 18 to 70 years, pain intensity at least 50 mm on VAS Exclusion criteria: any disorder which might interfere with the study drug, usage of anticoagulants or other drugs which may interfere with the treatment assessment, pregnancy, breastfeeding, or hormonal contraception |
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| Interventions | NSAID (i): aceclofenac 150 mg IM b.i.d. for 2 days + 100 mg tablets b.i.d. for 5 days + 1 placebo tablet for 5 days (N = 50) NSAID (ii): diclofenac 75 mg IM b.i.d. for 2 days + 50 mg tablets t.i.d. for 5 days (N = 50) | |
| Outcomes | Mean improvement in pain intensity (VAS; 0 to 100 mm) after 8 days: (i) 65 (ii) 62 Global improvement good/very good in (i) 87% and (ii) 79% of participants Adverse events: (i) 1 (ii) 6 participants |
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| Funding | Not mentioned | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomisation procedure not described |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes ‐ participants | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes ‐ careproviders | Unclear risk | Not mentioned |
| Blinding of outcome assessment (detection bias) All outcomes ‐ outcome assessors | Unclear risk | Not mentioned |
| Incomplete outcome data (attrition bias) All outcomes ‐ dropouts | Low risk | (i) 9/50 withdrew = 18% (ii) 8/50 withdrew = 16% |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis | Unclear risk | No ITT analysis mentioned |
| Selective reporting (reporting bias) | Unclear risk | No study protocol |
| Similarity at baseline characteristics | Low risk | Baseline characteristics similar |
| Co‐interventions avoided or similar | Unclear risk | Not mentioned |
| Compliance acceptable | Unclear risk | Not mentioned |
| Timing outcome assessments similar | Low risk | Timing similar |
| Other bias | Low risk | None |