Skip to main content
. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Cross‐over RCT
Participants Country of study: USA
Setting: tertiary care teaching hospital
Condition: neuromuscular pain (excluding fibromyalgia)
Prior management details: unclear
n = 28
Age: 45‐65 years, mean 55.6
Duration of symptoms: 4‐45 years, mean 15
Gender distribution: 25 M, 3 F
Interventions Stimulation type: CES
Stimulation parameters: frequency 0.5 Hz; pulse width not specified; intensity 10‐600 μA; waveform shape not specified
Stimulation location: ear clip electrodes
Number of treatments: 12, frequency of treatment not specified
Control type: sham CES unit indistinguishable from active unit
Outcomes Primary: VAS 0‐5 pain intensity
When taken: pre‐ and post‐ each treatment
Secondary: life interference scale, sickness impact profile ‐ Roland Scale
When taken: not specified
Notes AEs: not reported
COI: no declaration made
Sources of support: no declaration made
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "each subject was randomly assigned to receive either the active or the sham treatment first"
Comment: method of randomisation not specified but less critical in cross‐over design
Adequate blinding of participants? Low risk Quote: "sham treatment was made possible by having the treatment delivered via a black box"
Comment: sham and active stimulators visually indistinguishable
Adequate blinding of assessors? Unclear risk Comment: blinding of assessors not reported
Incomplete outcome data (attrition bias) All outcomes High risk Comment: only 17 participants completed the study and this dropout (over 50%) is not clearly accounted for in the analysis
Selective reporting (reporting bias) Low risk Comment: primary outcome data presented clearly
Free from carry‐over effects? Low risk Quote: "Note that there were no significant differences in pain ratings pre‐post changes between the active and sham groups"
Study Size High risk Comment: < 50 participants per treatment arm
Study duration High risk Comment: < 2 weeks' follow‐up
Other bias Unclear risk Comment: participants also received local stimulation to the painful area that may have elicited a therapeutic effect