Colberg 1996.
| Methods | RCT; randomised, controlled, parallel, open multicentre study. Randomisation procedure not described. Follow‐up time: 8 days |
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| Participants | Population: 183 participants, 103 men, 80 women Setting: 12 centres of orthopaedic surgeons, internal specialists, and general practitioners in Germany Inclusion criteria: age 18 years or older, acute lumbago, onset within 48 hours prior to treatment Exclusion criteria: chronic or chronically recurrent LBP, disc prolapse, whiplash injury or direct trauma, history of, or active gastrointestinal ulcer, coagulation or bleeding disorders, hypersensitivity to analgesics or NSAIDs, use of oral anticoagulants or lithium therapy, pregnant or breastfeeding women, or women without adequate contraception | |
| Interventions | NSAIDs (i): meloxicam IV 1.5 mL (= 15 mg) IV on day 1 (1 injection), followed by 1 tablet (15 mg) daily for 7 days; 8 days (N = 92) NSAIDs (ii): diclofenac IM 3ml (= 75 mg) IM on day 1 (1 injection), followed by 1 tablet (100 mg, slow‐release) daily for 7 days; 8 days (N = 91) | |
| Outcomes | Percentage of participants with no or mild pain during movement after 8 days: (i) 91%; (ii) 88% Percentage of participants recovered after 8 days, on overall improvement, functional status, and tolerance: (i) 89%, 67%, 96%; (ii) 91%, 54%, 95% Adverse events: (i) 6 participants (1 severe), (2 withdrew), (ii) 8 participants (1 severe), (2 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 | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes ‐ careproviders | Unclear risk | Not mentioned |
| Blinding of outcome assessment (detection bias) All outcomes ‐ outcome assessors | Unclear risk | Not mentioned |
| Incomplete outcome data (attrition bias) All outcomes ‐ dropouts | Low risk | Low dropout rate: 5,5% (10/183) In both groups, 3 withdrawals because of insufficient efficacy, and 2 because of an adverse event; total withdrawals: 10 participants |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis | Low risk | ITT analysis performed |
| 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 | Compliance was assessed by the dispensing record and the number of trial medication tablets taken, but not mentioned in results. |
| Timing outcome assessments similar | Low risk | Timing similar |
| Other bias | Low risk | None |