Orava 1986.
| Methods | RCT; double‐blind, multicentre. Randomization procedure not described. Follow‐up time: 1 week. |
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| Participants |
Population: 133 participants, 41 women, 92 men. Age range 18 to 71 Setting: multicentre investigation at 8 cities by 8 physicians, conducted in Finland Inclusion criteria: acute lumbago, onset less than 2 weeks ago, bothersome LBP and considerable functional disability, no previous use of analgesics, antiinflammatory, or muscle relaxing agents for this episode Exclusion criteria: stable, chronic LBP; LBP due to disorders of the pelvic region or spinal disorders (prolapse/hernia of an intervertebral disc); pregnancy or nursing; hypersensitivity to salicylates or indomethacin; current treatment with systemic corticosteroids or anticoagulants; active peptic ulcer or gastrointestinal haemorrhage; significant liver of kidney disease; haemopoietic disorders |
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| Interventions | NSAID (i): diflunisal 500 mg (capsules) b.i.d.; 7 days (N = 66) NSAID (ii): indomethacin 50 mg (capsules) t.i.d.; 7 days (N = 67) | |
| Outcomes | Data shown in graphs, extracted from graphs. Mean score difference in pain (4‐point Likert scale, range 0 to 3, no pain to severe pain) 0 to 7 days: (i) ‐1.0, (ii) ‐1.1 (at rest); (i) ‐1.6, (ii) ‐1.5 (on active movement). No significant differences Mean score difference in functional disability (4‐point Likert scale, range 0 to 3, no disability to severe disability) 0 to 7 days: (i) ‐1.5, (ii) ‐1.55. No significant differences Adverse events: (i) 12 participants = 18.2% (2 withdrew), (ii) 21 participants = 31.3% (6 withdrew) |
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| Funding | Not mentioned | |
| Notes | Partially flare participants: 126 participants with acute lumbago, 7 participants with acute exacerbation of chronic lumbago; no subgroup analysis | |
| 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 | The number and dosing of both medicines were made similar in both groups. |
| 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 | Low dropout rate: 6% (8/133 withdrew) |
| 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 | 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 |