Methods | RCT Number analysed/randomised: 29/31 Intention‐to‐treat: NR Power analysis: NR Funding source: NR | |
Participants | Chronic myofascial neck pain Participant recruitment: patients recruited from the clinic of the Department of Physical Medicine and Rehabilitation in Turkey |
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Interventions | INDEX TREATMENT Electroacupuncture group (EAP) 7 acupuncture points ‐ Du14 and GB20, GB21, LI4, UB10, UB60, TE5 all bilaterally and manually stimulated on insertion to Teh Chi (Deqi), EAP added after 1 to 4 Hz, 200 µs COMPARISON TREATMENT Sham EAP Same points as the treatment group; needles inserted 1 to 2 cm away from the meridian points. No Deqi. EAP stimulated, then turned off CO‐INTERVENTION NR Treatment schedule: 10 sessions over 3 weeks, with each session averaging 30 minutes in duration Duration of follow‐up: immediate post treatment, 3 months |
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Outcomes | PAIN INTENSITY (10 point VAS (movement) scale) Baseline mean: EAP 7.38, sham EAP 6.19 End of study mean: EAP 4.50, sham EAP 4.50 Absolute benefit: EAP 2.88, sham EAP 1.69 Reported results: not significant, including pain at rest SMD ‐0.56 (95% CI random ‐1.31 to 0.19) immediate post treatment SMD 0.00 (95% CI random ‐0.73 to 0.73) at 3 months Reasons for drop‐out: 2 participants in the EAP group: 1 unable to obtain permission from work to attend; 1 planning a pregnancy Adverse effects: NR Costs of care: NR |
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Notes | ‐‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Not described |
Allocation concealment (selection bias) | High risk | Names sealed in opaque envelopes. Envelopes were then allocated randomly into 2 groups. After the doctor examined participants, she gave the names of those who were included in the study to someone else, who prepared the envelopes |
Blinding (performance bias and detection bias) All outcomes ‐ patient? | Low risk | Reported as 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 | Participant blinded as outcome assessor |
Incomplete outcome data (attrition bias) All outcomes ‐ Drop out rate acceptable? | Low risk | Described and acceptable |
Incomplete outcome data (attrition bias) All outcomes ‐ Analyzed in the group to which they were allocated? | High risk | All randomised participants not analysed |
Selective reporting (reporting bias) | Unclear risk | No protocol |
Similarity of baseline characteristics | High risk | VAS pain scores > 10% difference |
Co‐interventions avoided or similar? | Unclear risk | Not reported |
Compliance acceptable? | Unclear risk | Not reported |
Similar timing of outcome assessment? | Low risk | Assessed immediate post treatment and 3 months |
Fatal Flaw | High risk | Randomisation not performed properly; planned to recruit 80 participants but enrolled only 31 |