Methods | RCT Number analysed/randomised: 24/24 Intention‐to‐treat: NR Power analysis: NR Funding source: NR | |
Participants | Chronic neck pain Participant recruitment: selected from 5 large companies in Oslo by the company's occupational physician, Norway |
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Interventions | INDEX TREATMENT Acupuncture 16 body points, 6 ear points, electrostimulation COMPARISON TREATMENT Placebo 10 to 14 mm distal to real points or 4 to 6 mm for ear points; electrostimulation set up but no voltage CO‐INTERVENTION Reported, see 'Risk of bias' Treatment schedule: 3 times per week, over 3 to 4 weeks, for a total of 10 treatments, with each session averaging 45 minutes in duration Duration of follow‐up: immediate post treatment, 6 months, 3 years |
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Outcomes | PAIN INTENSITY (0 to 100 VAS scale) Baseline mean: acupuncture 57, placebo 48 End of study mean: acupuncture 15, placebo 36 immediate post treatment Absolute benefit: acupuncture 42, placebo 12 Reported results: statistically significant favouring acupuncture at immediate post and 6 month follow‐up SMD ‐3.17 (95% CI random ‐4.44 to ‐1.90) immediate post treatment SMD ‐1.54 (95% CI random ‐2.47 to ‐0.61) at 6 months SMD ‐2.72 (95% CI random ‐3.89 to ‐1.56) at 3 years Drop‐outs: none Adverse effects: NR Costs of care: NR |
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Notes | ‐‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation by draw with replacement |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes ‐ patient? | Low risk | Described in report |
Blinding (performance bias and detection bias) All outcomes ‐ care provider? | High risk | Not possible |
Blinding (performance bias and detection bias) All outcomes ‐ outcome assessor? | Low risk | Described in report |
Incomplete outcome data (attrition bias) All outcomes ‐ Drop out rate acceptable? | Low risk | No drop‐outs |
Incomplete outcome data (attrition bias) All outcomes ‐ Analyzed in the group to which they were allocated? | Low risk | All participants randomised were analysed, described in report |
Selective reporting (reporting bias) | Unclear risk | No protocol |
Similarity of baseline characteristics | High risk | Not similar with respect to PPT and duration of symptoms; also headache baseline information not provided |
Co‐interventions avoided or similar? | High risk | 21% of the intervention group and 50% of the control group received other treatment |
Compliance acceptable? | Low risk | All participants completed all 10 treatments |
Similar timing of outcome assessment? | Low risk | All assessed immediate post, 6 months, 3 years |
Fatal Flaw | Low risk | Acceptable |