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. 2016 Nov 17;2016(11):CD004870. doi: 10.1002/14651858.CD004870.pub5
Methods RCT, pilot Number analysed/randomised: 178/190 Intention‐to‐treat: Not all randomised participants were analysed Power analysis: calculated 90% Funding source: NR
Participants Chronic mechanical neck disorder
Participant recruitment: outpatient clinic of Guangdong Provincial Hospital of Chinese Medicine in Guangzhou, China
Interventions INDEX TREATMENT
Acupuncture group Acupuncture points ‐ Du14, SI15 and Ex‐HN15 bilaterally manually stimulated on insertion for Deqi. Needles were inserted into the muscle (to a depth of 20 mm), left in place for 20 minutes. During treatment, participants received infrared irradiation on the cervical region
COMPARISON TREATMENT
Sham Participants in the control group received placebo acupuncture on the sham points, which were 1 cm lateral to the standard acupuncture points selected in the study group. Needles were inserted into the skin to a depth of approximately 3 mm and remained in the subcutaneous tissues with no manual stimulation. During treatment, participants in the control group also received infrared irradiation on the cervical region
CO‐INTERVENTION
NR
Treatment schedule: 3 weeks, total 9 sessions, with each session averaging 20 minutes in duration Duration of follow‐up: immediate post, 4 weeks, 3 months
Outcomes PAIN INTENSITY (VAS 10 cm scale) Baseline mean: acupuncture 5.30, sham 5.49 End of study mean: acupuncture 2.88, sham 3.19 Absolute benefit: acupuncture 2.48, sham 2.3 Reported results: significant favouring acupuncture SMD ‐0.30 (95% CI random ‐0.59 to ‐0.00) immediate post treatment
SMD ‐0.40 (95% CI random ‐0.69 to ‐0.10) at 4 weeks
SMD ‐0.20 (95% CI random ‐0.50 to 0.09) at 3 months
NECK DISABILITY: NPQ
Baseline mean: acupuncture 32.73, sham 33.04
End of study mean: acupuncture 19.09, sham 23.53
Absolute benefit: acupuncture 13/64, sham 9.51
Reported results: significant favouring acupuncture
SMD ‐0.28 (95% CI random ‐0.57 to 0.02) immediate post treatment
SMD ‐0.37 (95% CI random ‐0.67 to ‐0.07) at 4 weeks
SMD ‐0.37 (95% CI random ‐0.67 to ‐0.07) at 3 months
QUALITY OF LIFE: SF‐36 (Physical Component ‐ higher = better)
Baseline mean: acupuncture 80.79, sham 79.22
End of study mean: acupuncture 84.26, sham 85.88
Absolute benefit: 3.47, sham 6.66
Reported results: no significant differences between groups
SMD 0.38 (95% CI random 0.08 to 0.68) immediate post treatment
SMD ‐0.05 (95% CI random ‐0.35 to 0.24) at 4 weeks
SMD ‐0.11 (95% CI random ‐0.40 to 0.18) at 3 months Reasons for drop‐out: 5 drop‐outs in treatment group: 3 due to fear of pain and 2 for inconvenience. 7 drop‐outs in sham group: 4 due to fear of pain and 3 due to inconvenience Adverse effects: local bleeding, fainting: 3 participants in treatment and 4 in control; local numbness, aching or bleeding at points: 4 participants in treatment and 2 in control. All adverse events transient and resolved, although those who fainted decided to withdraw from the study Costs of care: NR
Notes ‐‐
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random numbers were generated by computer software
Allocation concealment (selection bias) Low risk Sealed opaque 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 Reported in text and acceptable
Incomplete outcome data (attrition bias) All outcomes ‐ Analyzed in the group to which they were allocated? High risk Not all randomised participants were 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 reported
Similar timing of outcome assessment? Low risk Assessed immediate post treatment, 4 weeks, 3 months
Fatal Flaw Low risk Acceptable