Predel 2013b.
Methods | R, DB, PC, parallel groups 2 g gel applied with fingertips over affected area and massaged in for 1 minute. Treatment for 5 days Assessed at baseline, 2, 3, 5 days | |
Participants | Uncomplicated neck pain originating from cervical joints and accompanying soft tissues (≥ 12 hours but < 3 months), PI ≥ 50/100
N = 72 M 33, F 39 Mean age 34 years |
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Interventions | Diclofenac gel (Voltaren Emulgel), 4 x 2 g daily, n = 36
Placebo gel, 4 x 2 g daily, n = 36 Rescue medication: paracetamol up to 2 g daily No concomitant therapies allowed |
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Outcomes | ≥ 50% decrease in PI on movement after 48 hours
PGE: 5‐point scale (responder = "good" or "excellent" at 5 days Adverse events Withdrawals |
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Notes | Oxford Quality Score: R2, DB2, W1. Total = 5/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sponsor "produced randomisation list" |
Allocation concealment (selection bias) | Low risk | Automated remote system |
Blinding (performance bias and detection bias) All outcomes | Low risk | "identical in packaging, labelling, schedule of administration, appearance and odour" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
Size | High risk | < 50 participants per treatment arm |