Wiesel 1980.
Methods | RCT; randomisation procedure not described; prospective study Follow‐up time: 2 weeks |
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Participants |
Population: 45 participants admitted to a military hospital for bedrest, all men, aged 17 to 34 years (mean age 23 years) Setting: army hospital in the USA Inclusion criteria: non‐radiating LBP, no previous back pain, normal neurologic and straight leg raising results, normal lumbar roentgenograms Exclusion criteria: discovering entities, such as spina bifida, on the roentgenogram |
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Interventions | All participants were admitted to the army hospital for bedrest. NSAID (i): aspirin 625 mg capsules, 4 times per day, 2 weeks (N = 15) NSAID (ii): phenylbutazone 100 mg capsules, 4 times per day (first 5 days), no further information (N = 15) Reference treatment (iii): acetaminophen (dosage not given), twice daily, 2 weeks (N = 15) |
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Outcomes | Mean no. of days before return to full activity (i) 5.7 (ii) 6.5 (iii) 5.7. No significant differences. No data on side‐effects given. |
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Funding | Not mentioned | |
Notes | Study population consisted of young, US army men (combat trainees), which is a different population than usual. Phenylbutazone was taken off the market due to severe adverse effects. |
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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 | High risk | Not blinded |
Blinding of participants and personnel (performance bias) All outcomes ‐ careproviders | High risk | Not blinded |
Blinding of outcome assessment (detection bias) All outcomes ‐ outcome assessors | High risk | Not blinded |
Incomplete outcome data (attrition bias) All outcomes ‐ dropouts | Unclear risk | Not mentioned |
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 study section on NSAIDs |
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 |