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 |
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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 |
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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 |
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Notes | AEs: not reported COI: no declaration made Sources of support: no declaration made |
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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 |