Lacey 1984.
| Methods | RCT; double‐blind, placebo‐controlled. Randomisation procedure not described. Follow‐up time: 14 days Information extracted from subgroup with acute back sprain |
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| Participants |
Population: subgroup of 337 participants with acute back or sacroiliac pain (< 72 hours). Age and sex ratio unknown Setting: 215 participating general practitioners, conducted in the United Kingdom Inclusion criteria: acute back or sacroiliac pain, diagnosed within the last 72 hours or less Exclusion criteria: not mentioned |
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| Interventions | NSAID (i): piroxicam 10 mg capsules, four times per day first two days, two times per day next 12 days; 14 days (N = 168) Reference treatment (ii): identical placebo capsules, four times per day first two days, two times per day next 12 days; 14 days (N = 169) | |
| Outcomes | Participant (%) improved after 1 week only in subgroups with initial moderate/severe pain (i) 82%/49% (ii) 53%/38%. No differences for subgroup with mild initial pain. Results after 2 weeks not reported. No data presented on adverse events for subgroup with back pain. The overall numbers, including other musculoskeletal disorders, were similar: (i) 12% (3% withdrew) (ii) 9% (2,5% withdrew). |
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| Funding | Not mentioned. Statistical help was given by an employee of Pfizer Central Research. | |
| 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 | Low risk | Double‐blind, identical placebo capsules |
| Blinding of participants and personnel (performance bias) All outcomes ‐ careproviders | Low risk | Double‐blind, identical placebo capsules |
| Blinding of outcome assessment (detection bias) All outcomes ‐ outcome assessors | Unclear risk | Not mentioned |
| Incomplete outcome data (attrition bias) All outcomes ‐ dropouts | Unclear risk | Not mentioned for subgroup |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis | Unclear risk | Not mentioned |
| Selective reporting (reporting bias) | Unclear risk | No study protocol |
| Similarity at baseline characteristics | Unclear risk | Baseline characteristics not mentioned for subgroup |
| 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 |