Szpalski 1990.
| Methods | RCT; use of randomisation table Follow‐up time: 14 days (clinical assessment at days 0 and 14) |
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| Participants |
Population: 110 participants, 51 women, 59 men. Mean age (SD): 40.2 (13.7) years Setting: an outpatient department (October 1988 to March 1999), conducted in Belgium Inclusion criteria: acute LBP, pain present < 2 weeks, asymptomatic period of at least 4 months Exclusion criteria: LBP related to industrial accident covered by insurance, specific (spinal) pathology, such as disc protrusion or spinal trauma |
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| Interventions | NSAID (i): tenoxicam 20 mg, 1 tablet daily (14 days), and bedrest (7 days strict, 7 days intermittent; (N = 49) Reference treatment (ii): bedrest, (7 days strict, 7 days intermittent; (N = 50) | |
| Outcomes | Mean % improvement (SD) between baseline and 14 days in ROM (i) 123 (24), (ii) 114 (23); significant (P < 0.05) After 14 days of treatment: 86% (i) versus 70% (ii) no need for further treatment Adverse events: (i) 2 participants (2 withdrew) |
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| Funding | Not mentioned | |
| Notes | Physical examination only outcome. Outcome presented as percentages, baseline values not presented. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | A randomisation table was used |
| Allocation concealment (selection bias) | High risk | Not possible by study design; no placebo control |
| 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 | Low risk | Low dropout rate: 10% (11/110) |
| 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 similar, but only age and sex mentioned, no other baseline values presented. |
| 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 |