Itoh 2007

Methods	RCT Number analysed/randomised: 31/40 Intention‐to‐treat: not calculated Power analysis: not calculated Location: Japan Funding source: Japan Society of Acupuncture and Moxibustion
Participants	Chronic neck pain, no radicular signs Participant recruitment: Participants were recruited from the Meiji University of Oriental Medicine Hospital
Interventions	INDEX TREATMENT 1 Standard acupuncture (SA) Acupuncture points local: GB20, GB21, BL10, BL11, SI12, SI13; distal TE5, LI4, SI3 Inserted needles into the muscle (depth of 20 mm) using 'sparrow pecking' technique; manipulation stopped when participants reached Deqi, and needles were left in place for an additional 10 minutes INDEX TREATMENT 2 Trigger point acupuncture (TrP) Local needling of myofascial trigger points (mean number of insertions 2.3) Needles were inserted 20 mm into the skin over the trigger point by the 'sparrow pecking' technique. Manipulation was stopped when the local twitch response was elicited, and the needle was left in place for an additional 10 minutes INDEX TREATMENT 3: Non‐trigger point acupuncture (non‐TrP) Non‐TrP group received the same treatment as above but at non‐tender points (mean number of insertions 2.4). The non‐tender point chosen had no tenderness nor taut muscle band. However, the point was selected in the same muscle but away from the trigger point by 50 mm COMPARISON TREATMENT Sham acupuncture (SH) SH groups received treatment at trigger points. Similar stainless steel needles were used, but the tips had been cut off and smoothed to prevent penetration of the skin by the needle with the 'sparrow pecking' technique. Simulation of needle extraction was performed after 10 minutes (mean number of insertions 2.6) CO‐INTERVENTION Not specified Treatment schedule: 6 treatments within 10 weeks; applied in 2 phases of 3 treatments: 3 treatments within first 3 weeks, no treatment from week 4 to 7 and 3 treatments from week 7 to 10 Duration of follow‐up: 3 weeks
Outcomes	Groups PAIN INTENSITY (VAS 0 to 100 mm) Baseline mean: SA 69.5, TrP 67.0, non‐TrP 70.9, SH 64.1 End of study mean: SA 51.6, TrP 11.0, non‐TrP 57.6, SH 53.9 Absolute benefit: SA 17.9, TrP 56.0, non‐TrP 13.3, SH 10.2 Reported results: statistically significant improvement in the TrP group only SA vs SH: SMD ‐0.24 (95% CI random ‐1.26 to 0.78) immediate post treatment SA vs SH: SMD ‐0.10 (95% CI random ‐1.11 to 0.92) at 3 weeks TrP vs SH: SMD ‐2.77 (95% CI random ‐4.31 to ‐1.24) immediate post treatment TrP vs SH: SMD ‐2.37 (95% CI random ‐3.78 to ‐0.95) at 3 weeks Non‐TrP vs SH: SMD 0.23 (95% CI random ‐0.79 to 1.25) immediate post treatment Non‐TrP vs SH: SMD ‐0.01 (95% CI random ‐1.03 to 1.00) at 3 weeks DISABILITY: NECK DISABILITY INDEX (NDI 0 to 50 point scale) Baseline mean: SA 12.6, TrP 13.0, non‐TrP 15.1, SH 12.0 End of study mean: SA 10.9, TrP 3.1, non‐TrP 12.0, SH 11.1 Absolute benefit: SA 1.7, TrP 9.9, non‐TrP 3.1, SH 0.9 Reported results: TrP group demonstrated greatest improvement SA vs SH: SMD ‐0.19 (95% CI random ‐1.21 to 0.83) immediate post treatment SA vs SH: SMD ‐0.03 (95% CI random ‐1.05 to 0.98) at 3 weeks TrP vs SH: SMD ‐2.81 (95% CI random ‐4.36 to ‐1.26) immediate post treatment TPA vs SH: SMD ‐1.82 (95% CI random ‐3.09 to ‐0.56) at 3 weeks Non‐TrP vs SH: SMD 0.38 (95% CI random ‐0.65 to 1.41) immediate post treatment Non‐TrP vs SH: SMD 0.18 (95% CI random ‐0.84 to 1.20) at 3 weeks Drop‐outs due to no response to treatment: SA 1, TPA 1, NTPA 1, SH 1 Drop‐outs due to adverse effects: deterioration of symptoms, not specified SA 1, TPA 1, NTPA 0, SH 1 Costs of care: NR
Notes	‐‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes ‐ patient?	High risk	Participants not adequately 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?	High risk	Participant as outcome assessor not blinded adequately
Incomplete outcome data (attrition bias) All outcomes ‐ Drop out rate acceptable?	High risk	Discrepancy between Table 2, Figure 3 and text
Incomplete outcome data (attrition bias) All outcomes ‐ Analyzed in the group to which they were allocated?	High risk	n's in Figure 3 do not add up
Selective reporting (reporting bias)	Unclear risk	No protocol
Similarity of baseline characteristics	Unclear risk	Table 2 gives only baseline info on those who completed the trial, not those randomised
Co‐interventions avoided or similar?	Unclear risk	Not reported
Compliance acceptable?	Unclear risk	Not reported
Similar timing of outcome assessment?	Low risk	Assessed immediately post treatment
Fatal Flaw	High risk	Numbers in flow charts and tables do not add up