Bakshi 1994.
| Methods | RCT; double‐blind, multicentre study. Randomisation procedure not described. Follow‐up time: 14 days |
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| Participants |
Population source: 132 participants, 62 men, 70 women Setting: 7 outpatient clinics in Austria Inclusion criteria: acute back pain less than 1 week, moderate to severe pain (> 50 mm on VAS), at least 2 objective signs of lumbosacral pathology (tenderness, limited ROM, or SLR < 75 degrees), LBP due to mechanical cause Exclusion criteria: hypersensitivity to aspirin or NSAIDs, gastroduodenal ulcer, history of gastrointestinal bleeding, severe cardiac, hepatic, or renal insufficiency, severe hypertension, history of haemopoietic or bleeding disorders, pregnancy, sensory or motor deficits in lower extremities, and infective, inflammatory, neoplastic, metabolic, or structural cause |
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| Interventions | NSAIDs (i): diclofenac 75 mg b.i.d., 14 days (N = 66) NSAIDs (ii): piroxicam 20 mg b.i.d. 2 days and after that, once a day plus a placebo capsule once a day for 12 days (N = 66) | |
| Outcomes | Mean pain intensity at rest (VAS) at baseline and after 4, 8, and 15 days: (i) 70.0, 43.3, 30.6, 22.7; (ii) 67.1, 44.5, 27.8, 21.0 No. (%) of participants improved after 14 days: (i) 54 (82%), 58 (88%). Not significant Adverse events (i) 13 participants (1 withdrawal), (ii) 12 participants (4 withdrawals) |
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| Funding | Funding by Ciba‐Geigy (now Novartis), developer of diclofenac resinate | |
| Notes | Some participants with additional radicular symptoms, not clear how many; 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 | Matching capsules were provided to maintain double‐blind conditions. |
| Blinding of participants and personnel (performance bias) All outcomes ‐ careproviders | Low risk | Matching capsules were provided to maintain double‐blind conditions. |
| Blinding of outcome assessment (detection bias) All outcomes ‐ outcome assessors | Unclear risk | Not mentioned |
| Incomplete outcome data (attrition bias) All outcomes ‐ dropouts | Low risk | Dropout rate 18% (24/132) |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis | Low risk | ITT analysis was performed |
| Selective reporting (reporting bias) | Unclear risk | No study protocol |
| Similarity at baseline characteristics | Low risk | Baseline characteristics similar |
| Co‐interventions avoided or similar | Low risk | Administration of analgesic/anti‐inflammatory drugs other than the study medication was not permitted during the trial. In the 3 days preceding the trial, only paracetamol was allowed. |
| Compliance acceptable | Unclear risk | Not mentioned |
| Timing outcome assessments similar | Low risk | Timing similar |
| Other bias | Low risk | None |