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. 2016 Nov 17;2016(11):CD004870. doi: 10.1002/14651858.CD004870.pub5
Methods RCT Number analysed/randomised: 34/35 Intention‐to‐treat: calculated Power analysis: calculated 90% Funding source: NR
Participants Myofascial neck pain syndrome (MPS)
Participant recruitment: Department of Neurology at Nantou Hospital, Department of Health
Interventions INDEX TREATMENT
Acupuncture group 5 predetermined acupuncture points ‐ TE14, GB20, SI3 bilaterally manually stimulated on insertion to Qi
COMPARISON TREATMENT
Sham acupuncture Same points as treatment group. Inserted into subcutaneous tissue at 2 mm depth. No manual stimulation
CO‐INTERVENTION
NR
Treatment schedule: 2 sessions/wk for 3 consecutive weeks, with each session averaging 20 minutes in duration Duration of follow‐up: immediate post, 4 weeks, 12 weeks
Outcomes PAIN INTENSITY (100 point VAS (movement) scale) Baseline mean: acupuncture 50, sham acupuncture 50 End of study mean: acupuncture 30, sham acupuncture 30 Absolute benefit: acupuncture 20, sham acupuncture 20 Reported results: no significance differences between groups SMD ‐0.42 (95% CI random ‐1.10 to 0.26) immediate post treatment
SMD ‐0.54 (95% CI random ‐1.22 to 0.15) at 4 weeks SMD 0.00 (95% CI random ‐0.67 to 0.67) at 12 weeks Reasons for drop‐out: discontinued because of Chinese herb use Adverse effects: 1 participant in treatment group experienced ecchymosis, 1 in control group experienced slight dizziness; both were transient and resolved Costs of care: NR
Notes ‐‐
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not clear if adequately done
Allocation concealment (selection bias) Unclear risk Not reported
Blinding (performance bias and detection bias) All outcomes ‐ patient? Unclear risk Some participant were not naive to acupuncture
Blinding (performance bias and detection bias) All outcomes ‐ care provider? High risk Not possible
Blinding (performance bias and detection bias) All outcomes ‐ outcome assessor? Unclear risk Unclear whether participant was blinded and was also the outcome assessor
Incomplete outcome data (attrition bias) All outcomes ‐ Drop out rate acceptable? Low risk Reported and acceptable
Incomplete outcome data (attrition bias) All outcomes ‐ Analyzed in the group to which they were allocated? Unclear risk Appears 1 randomised participant may not have been analysed
Selective reporting (reporting bias) Unclear risk No protocol
Similarity of baseline characteristics Low risk Reported to be similar
Co‐interventions avoided or similar? Unclear risk Not reported
Compliance acceptable? Unclear risk Not specifically and clearly reported
Similar timing of outcome assessment? Low risk Assessed after 6 treatments, 4 weeks, 12 weeks
Fatal Flaw High risk Randomisation not clearly done properly; participants do not appear to have been blinded; ITT not done; missing data handled by last observation carried forward; all P values in Table 2 within‐group changes; scores in Table 3 do not look credible