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. 2016 Nov 17;2016(11):CD004870. doi: 10.1002/14651858.CD004870.pub5
Methods RCT cross‐over Number analysed/randomised: 132/132 Power analysis: Post hoc analysis suggested 70 participants per group were needed Intention‐to‐treat analysis: NA
Funding source: NR
Participants Chronic mechanical neck disorder, cervical osteoarthritis
Participant recruitment: Sweden
Interventions INDEX TREATMENT Acupuncture (Acu): LI3 and GB20 bilaterally, DU14, DU16, DU20 with manual stimulation for 10s for Deqi every 5 minutes, 40 minute session COMPARISON TREATMENT Sham acupuncture: needles inserted superficially, not manually stimulated CO‐INTERVENTION
Instructed to take no pain medication 24 hours before trials Duration of treatment: 1 session Duration of follow‐up: 2 hours
Outcomes PAIN INTENSITY (VAS 0 to 10) Baseline: acupuncture 2.5, placebo acupuncture 2.0, placebo diazepam 1.9 End of study mean: acupuncture 1.8, placebo 1.6, placebo diazepam 1.7 Absolute benefit: acupuncture 0.7, placebo 0.4, placebo diazepam 0.2 Reported results: not significant when acupuncture was compared with placebo acupuncture but statistically significant when acupuncture was compared with placebo diazepam
vs placebo acupuncture: SMD 0.17 (95% CI random ‐0.25 to 0.59) immediate post treatment
vs placebo diazepam: SMD 0.09 (95% CI random ‐0.33 to 0.51) immediate post treatment Adverse effects: NR Costs of care: NR
Notes ‐‐
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Only described as randomised to order
Allocation concealment (selection bias) Unclear risk Not reported
Blinding (performance bias and detection bias) All outcomes ‐ patient? High risk Interventions perceivably different
Blinding (performance bias and detection bias) All outcomes ‐ care provider? High risk Not possible
Blinding (performance bias and detection bias) All outcomes ‐ outcome assessor? High risk Participant not blinded as outcome assessor
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 randomised participants were analysed
Selective reporting (reporting bias) Unclear risk No protocol
Similarity of baseline characteristics Low risk Each participant received all treatments
Co‐interventions avoided or similar? Low risk Avoided
Compliance acceptable? Low risk All participants received all treatments
Similar timing of outcome assessment? Low risk Immediate post treatment
Fatal Flaw High risk Improper error terms for analysis (SD should not be used for within‐patient analysis); randomisation and concealment not described; no adjustments made for order; balancing not apparent