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. 2016 Nov 17;2016(11):CD004870. doi: 10.1002/14651858.CD004870.pub5
Methods RCT
Number analysed/randomised: 40/40 Intention‐to‐treat: reported Power analysis: NR
Funding source: University of Tsukuba, Japan
Participants WAD symptoms 3 months or longer
Participant recruitment: through advertisements in local newspapers and on the homepage of the Kyung Hee Medical Center
Interventions INDEX TREATMENT
Acupuncture
Acupuncture points from the gallbladder (GB), small intestine (SI), bladder (BL), triple energiser (TE) and large intestine (LI) meridian systems located on shoulder, neck, head and upper limbs. Needles (length 40 mm; diameter 0.16 mm, SEIRIN Co. Ltd) were inserted perpendicularly to a depth of 1.0 to 2.0 cm in place for 15 minutes
COMPARISON
Wait‐list
CO‐INTERVENTION
Both groups maintained their usual care, including physiotherapy, exercise and sufficient rest
Treatment schedule: Treatment consisted of 6 sessions, 3×/wk for 2 weeks
No follow‐up
Outcomes PAIN INTENSITY (0 to 10 VAS scale) Baseline mean: acupuncture 4.59, wait‐list 4.88 End of study mean: acupuncture 2.74, wait‐list 4.47 immediate post treatment Absolute benefit: acupuncture 1.85, wait‐list 0.41 Reported results: statistically significant favouring acupuncture
Drop‐outs: none Adverse effects: 3 acupuncture participants reported mild adverse events (2 with bruising, 1 with fatigue)
No serious side effects reported Costs of care: NR
Notes Unable to reach study author to obtain necessary data for abstraction
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computerised number table generated random sequences
Allocation concealment (selection bias) Unclear risk Envelopes sealed but not sequentially numbered (numbers inside)
Blinding (performance bias and detection bias) All outcomes ‐ patient? High risk Not possible because of design
Blinding (performance bias and detection bias) All outcomes ‐ care provider? High risk Not possible because of design
Blinding (performance bias and detection bias) All outcomes ‐ outcome assessor? Unclear risk Participant was the outcome assessor with self reports
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 Acceptable
Selective reporting (reporting bias) Low risk See registration
Similarity of baseline characteristics Low risk Reported as similar in Tables 2, 3, 5
Co‐interventions avoided or similar? Unclear risk Not reported
Compliance acceptable? Unclear risk Not reported
Similar timing of outcome assessment? Low risk Baseline and 2 weeks
Fatal Flaw High risk Flawed; wrong analysis was used; Figure 2 should use independent t‐test, not paired t‐test