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. 2016 Nov 17;2016(11):CD004870. doi: 10.1002/14651858.CD004870.pub5
Methods RCT Number analysed/randomised: 29/31 Intention‐to‐treat: NR Power analysis: NR Funding source: NR
Participants Chronic myofascial neck pain
Participant recruitment: patients recruited from the clinic of the Department of Physical Medicine and Rehabilitation in Turkey
Interventions INDEX TREATMENT
Electroacupuncture group (EAP) 7 acupuncture points ‐ Du14 and GB20, GB21, LI4, UB10, UB60, TE5 all bilaterally and manually stimulated on insertion to Teh Chi (Deqi), EAP added after 1 to 4 Hz, 200 µs
COMPARISON TREATMENT
Sham EAP Same points as the treatment group; needles inserted 1 to 2 cm away from the meridian points. No Deqi. EAP stimulated, then turned off
CO‐INTERVENTION
NR
Treatment schedule: 10 sessions over 3 weeks, with each session averaging 30 minutes in duration Duration of follow‐up: immediate post treatment, 3 months
Outcomes PAIN INTENSITY (10 point VAS (movement) scale) Baseline mean: EAP 7.38, sham EAP 6.19 End of study mean: EAP 4.50, sham EAP 4.50 Absolute benefit: EAP 2.88, sham EAP 1.69
Reported results: not significant, including pain at rest
SMD ‐0.56 (95% CI random ‐1.31 to 0.19) immediate post treatment
SMD 0.00 (95% CI random ‐0.73 to 0.73) at 3 months Reasons for drop‐out: 2 participants in the EAP group: 1 unable to obtain permission from work to attend; 1 planning a pregnancy Adverse effects: NR Costs of care: NR
Notes ‐‐
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Not described
Allocation concealment (selection bias) High risk Names sealed in opaque envelopes. Envelopes were then allocated randomly into 2 groups. After the doctor examined participants, she gave the names of those who were included in the study to someone else, who prepared the envelopes
Blinding (performance bias and detection bias) All outcomes ‐ patient? Low risk Reported as blinded
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 Participant blinded as outcome assessor
Incomplete outcome data (attrition bias) All outcomes ‐ Drop out rate acceptable? Low risk Described and acceptable
Incomplete outcome data (attrition bias) All outcomes ‐ Analyzed in the group to which they were allocated? High risk All randomised participants not analysed
Selective reporting (reporting bias) Unclear risk No protocol
Similarity of baseline characteristics High risk VAS pain scores > 10% difference
Co‐interventions avoided or similar? Unclear risk Not reported
Compliance acceptable? Unclear risk Not reported
Similar timing of outcome assessment? Low risk Assessed immediate post treatment and 3 months
Fatal Flaw High risk Randomisation not performed properly; planned to recruit 80 participants but enrolled only 31