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 |
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Participants | Chronic mechanical neck disorder, cervical osteoarthritis Participant recruitment: Sweden |
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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 |
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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 |
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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 |