Szpalski 1994.
| Methods | RCT; double‐blind, placebo‐controlled. Randomisation procedure not described Follow‐up time: 15 days (clinical evaluation at days 1, 8, and 15) |
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| Participants |
Population source: 73 participants, 26 women, 47 men. Mean age approximately 38 years Setting: not mentioned Inclusion criteria: acute LBP, pain present for less than 2 weeks, first presentation or first reappearance after an asymptomatic period of at least 6 months Exclusion criteria: work accident covered by worker's compensation, spinal pathology (e.g. herniated disc or spinal trauma), pregnancy or lactation, hypersensitivity to NSAIDs, history of gastrointestinal ulceration, current use of NSAIDs, anticoagulants, oral antidiabetics, or lithium |
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| Interventions | NSAID (i): tenoxicam 20 mg IM injection on day 1 + 20 mg capsules, 1 per day, for day 2 to 14 (+ 7 days bedrest; (N = 37)) Reference treatment (ii): placebo IM injection on day 1 + placebo capsules, 1 per day, for day 2 to 14 (+ 7 days bedrest; (N = 36)) | |
| Outcomes | Mean pain intensity on VAS on day 1, 8, and 15 (SD): (i) 7.4 (1.5), 1.9 (2.0), 0.6 (1.1); (ii) 7.1 (2.0), 2.8 (2.0), 0.8 (1.1). (i) significantly better on day 8 (P = 0.043). Overall clinical assessment by the investigator after 1 week: (i) 27/33 (82%), (ii) 20/35 (57%) either markedly improved or cured, no significant differences Adverse events: (i) 1 participant (none withdrew) |
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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 | Low risk | Double‐blind, double‐dummy: active and placebo tablets were matched in appearance (shape, size and colour) |
| Blinding of participants and personnel (performance bias) All outcomes ‐ careproviders | Low risk | Double‐blind, double‐dummy |
| Blinding of outcome assessment (detection bias) All outcomes ‐ outcome assessors | Low risk | Double‐blind, double‐dummy |
| Incomplete outcome data (attrition bias) All outcomes ‐ dropouts | Low risk | Low dropout rate: 6.8% (5/73) |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis | Low risk | ITT analysis performed. 5 participants were not evaluated as they did not return for follow‐up after the baseline visit (4 from (i) and 1 from (ii)). |
| 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 |