Vas 2006

Methods	RCT Number analysed/randomised: 85/123 Intention‐to‐treat: calculated (although ITT stated, not all analysed at T2, only T1) Power analysis: calculated (90% power, alpha = 5%, 49 participants needed for experimental group and 46 for control group) Funding source: NR
Participants	Non‐specific cervical disorder, uncomplicated Participant recruitment: Participants were referred to the Pain Treatment Unit at a Primary Attention Healthcare Centre in Spain by general practitioners in the municipality
Interventions	INDEX TREATMENT Acupuncture Points were selected according to pain characteristics and accompanying symptoms on the basis of traditional Chinese treatment methods. Puncture was bilateral, with sterile, single‐use needles (25 mm × 0.25 mm or 40 mm × 0.25 mm). Puncture was effected by determining the Deqi. Needles were kept in place for 30 minutes and were manually stimulated every 10 minutes. After the needles were removed, Vaccaria seeds were applied in the ear auricle and were taped there until the following treatment session. Participants were told to apply pressure to each ear point for a series of 10 repeats 3 times per day COMPARISON TREATMENT TENS placebo Applied using TRANSMED 911 transcutaneous nerve stimulation units that had been adjusted beforehand to prevent current through the electrodes. Electrodes were placed at Jianjing (GB 21) bilateral acupuncture point for 30 minutes. Participant's state was checked every 10 minutes, and the TENS‐placebo potentiometer adjusted CO‐INTERVENTION Not avoided but comparable; both groups were provided with analgesic rescue medications once weekly Duration of treatment: 3 weeks Treatment consisted of 5 sessions over 3 weeks (2 in each of first 2 weeks and once in the third week) Duration of follow‐up: 6 months
Outcomes	PAIN INTENSITY (VAS 100 mm scale related to motion) Baseline mean: acupuncture 68.7, placebo TENS 72.3 End of study mean: acupuncture 27.6, placebo TENS 45.5 Absolute benefit: acupuncture 41.1, placebo TENS 26.8 SMD ‐1.50 (95% CI random ‐1.91 to ‐1.10) at 1 week SMD ‐0.54 (95% CI random ‐0.97 to ‐0.10) at 6 months FUNCTION (DISCAPACITY): Northwick Park Pain Questionnaire (NPQ 0 to 100 scale) Baseline mean: acupuncture 52.7, placebo TENS 56.5 End of study mean: acupuncture 22.5, placebo TENS 43.8 Absolute benefit: acupuncture 30.2, placebo TENS 12.7 Reported results: significant at 1 week after final treatment SMD ‐1.22 (95% CI random ‐1.60 to ‐0.83) at 1 week 6 month follow‐up for this outcome: NR QUALITY OF LIFE: SF‐36 (Physical Component ‐ higher = better) Baseline mean: acupuncture 36.7, placebo TENS 37.6 End of study mean: acupuncture 27.4, placebo TENS 32.3 Absolute benefit: acupuncture 9.3, placebo TENS 5.3 Results: significant difference at 1 week favouring acupuncture but not at 6 months SMD ‐0.57 (95% CI random ‐0.93 to ‐0.21) at 1 week SMD 0.41 (95% CI random ‐0.02 to 0.84) at 6 months Reasons for drop‐out: personal reasons, pregnancy, fear Adverse effects: mild for both groups (4 in treatment group, 2 in control group) Reported for control: increase in symptoms Reported for index treatment: swelling or bruising of the hand Costs of care: NR
Notes	‐‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computerised generated randomisation
Allocation concealment (selection bias)	Unclear risk	Opaque envelopes not reported as sequentially numbered
Blinding (performance bias and detection bias) All outcomes ‐ patient?	Low risk	Reported in text as participant 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	Blinded participant as outcome assessor
Incomplete outcome data (attrition bias) All outcomes ‐ Drop out rate acceptable?	High risk	Drop‐out approximately 35% at long term
Incomplete outcome data (attrition bias) All outcomes ‐ Analyzed in the group to which they were allocated?	High risk	Not reported for long term
Selective reporting (reporting bias)	Unclear risk	No protocol
Similarity of baseline characteristics	Low risk	Reported to be similar
Co‐interventions avoided or similar?	High risk	Reported only on medication use
Compliance acceptable?	Unclear risk	Unsure whether ear seed protocol was followed by each participant
Similar timing of outcome assessment?	Low risk	Assessed at 1 week and 6 months
Fatal Flaw	Low risk	Acceptable