Shirado 2010.
| Methods | RCT | |
| Participants | 201 participants, 112 women, 89 men; mean age 42.2 years Inclusion: age 20 to 64 years, nonspecific chronic low back pain ≥ 3 months without radicular pain, ≥ 70° at straight leg raising test, negative femoral nerve stretching test, no superficial sensory deficits, muscle strength ≥ 4/5 Exclusion: low back pain due to tumours, infections, fractures, previous back surgery, severe osteoporosis, psychiatric disorders, liver and renal dysfunction, pregnancy, medication for cardiac failure, history of cerebrovascular accident or myocardial infarction, or both, in previous 6 months |
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| Interventions | NSAID (i): 1 of the following 3 NSAIDs were prescribed: loxoprofen sodium 180 mg/day; diclofenac sodium 75 mg/day; zaltoprofen 240 mg/day, 12 weeks Reference treatment (ii): exercise programme with trunk muscle strengthening and stretching, 12 weeks |
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| Outcomes | Mean change from baseline to 8 weeks on 100 mm VAS was not different between (i) and (ii), P = 0.33 Mean change from baseline to 8 weeks on RDQ in favour of (ii), P = 0.02 |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated 4 block randomization |
| Allocation concealment (selection bias) | Low risk | Office manager concealed allocation |
| Blinding (performance bias and detection bias): All outcomes ‐ Patients All outcomes | High risk | NSAIDs versus exercise |
| Blinding (performance bias and detection bias): All outcomes ‐ Care providers All outcomes | High risk | NSAIDs versus exercise |
| Blinding (performance bias and detection bias): All outcomes ‐ Outcome assessors All outcomes | Low risk | Outcome assessor was blinded |
| Incomplete outcome data (attrition bias): All outcomes ‐ Drop‐outs All outcomes | Low risk | Two in exercise, 6 in NSAIDs. |
| Incomplete outcome data (attrition bias): All outcomes ‐ ITT analysis All outcomes | High risk | No ITT analysis performed. |
| Selective reporting (reporting bias) | Unclear risk | study protocol not attainable |
| Similarity of baseline characteristics | Low risk | Baseline characteristics were similar |
| Co‐interventions avoided or similar | Unclear risk | Rescue medication not mentioned |
| Compliance acceptable | Unclear risk | Compliance not mentioned |
| Timing outcome assessments similar | Low risk | Timing similar |