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. 2016 Nov 17;2016(11):CD004870. doi: 10.1002/14651858.CD004870.pub5
Methods RCT, cross‐over Number analysed/randomised: 34/36 Intention‐to‐treat: NA Power analysis: NR Funding source: German Ministry for Education and Research
Participants Chronic neck disorder without radicular symptoms
Participant recruitment: out‐patients from the Department of Physical Medicine and Rehabilitation and the Interdisciplinary Pain Unit at the University of Munich
Interventions INDEX TREATMENT 1
Non‐local needle acupuncture (NLA) at distant points according to the theory of channels of TCM and varied individually by therapist
INDEX TREATMENT 2
Dry needling (dn) of local myofascial trigger points with strong manual stimulation of 'ah shi' points
COMPARISON TREATMENT
Sham laser acupuncture (SHAM)
CO‐INTERVENTION
Not reported
Treatment schedule: each participant treated once with all interventions with a 1‐week wash‐out period and each session averaging 30 minutes in duration Duration of follow‐up: immediately following completion of each treatment
Outcomes PAIN INTENSITY (VAS 100 mm scale) for motion‐related pain Baseline mean: acupuncture (NLA) 35.0, (dn) 33.4, sham laser acupuncture 30.4 End of study mean: acupuncture (NLA) 19.1, (dn) 29.2, sham laser acupuncture 28.0 Absolute benefit: acupuncture (NLA) 15.9, (dn) 4.2, sham laser acupuncture 2.4 Reported results: NLA effective, dn not effective when compared with the sham SMD 0.49 (95% CI random ‐0.98 to ‐0.01) NLA group immediate post treatment
SMD 0.06 (95% CI random ‐0.42 to 0.54) dn group immediate post treatment
Reasons for drop‐out: NA Adverse effects: no serious adverse effects; however, 3 participants had mild hypotonia and sweating (1 from NLA and 2 from dn groups) Costs of care: NR
Notes ‐‐
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Cross‐over design, 6 possible sequences assigned to a number from 1 to 6, random list for 36 participants was then prepared by rolling dice
Allocation concealment (selection bias) Low risk Fully concealed
Blinding (performance bias and detection bias) All outcomes ‐ patient? Low risk Participant reported as blinded
Blinding (performance bias and detection bias) All outcomes ‐ care provider? High risk Not possible for acupuncture group, only sham laser acupuncture had caregiver blinded
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 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? Low risk Each participant received 1 treatment with each intervention with 1‐week wash‐out period between
Similar timing of outcome assessment? Low risk Assessed immediate post treatment
Fatal Flaw Low risk Acceptable