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 |
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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 |
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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 |
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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 |