Methods | RCT Number analysed/randomised: 40/40 Intention‐to‐treat: reported Power analysis: NR Funding source: University of Tsukuba, Japan |
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Participants | WAD symptoms 3 months or longer Participant recruitment: through advertisements in local newspapers and on the homepage of the Kyung Hee Medical Center |
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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 |
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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 |
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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 |