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. 2016 Nov 17;2016(11):CD004870. doi: 10.1002/14651858.CD004870.pub5
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
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
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
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