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 |
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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 |
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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 |
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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 |