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. 2009 Oct 7;2009(4):CD002823. doi: 10.1002/14651858.CD002823.pub2

Itoh 2008.

Methods Randomised controlled trial 
 2 x 2 factorial design 
 Trial duration: 10 weeks 
 No power calculation reported
Participants 32 patients randomised 
 32 patients with knee OA reported at baseline 
 Study joints: 32 knees 
 Number of females: 21 of 32 (66%)
Interventions Experimental intervention: interferential current stimulation*, once per week 
 Control intervention: no intervention, optional use of poultice
16 out of 32 patients (50%) allocated to acupuncture using a factorial design; no evidence for an interaction between treatments
Duration of treatment period: 5 weeks 
 Analgesics allowed and intake assessed, but unclear whether intake was similar.
Device: HV‐F3000 (single channel, 2 pole) 
 Self‐administered: no 
 Waveform: sinusoidal 
 Pulse width: not applicable 
 Pulse frequency: amplitude‐modulated frequency of 122 Hz (beat frequency) 
 Amplitude: above sensory threshold, up to a tingling sensation, 2 to 3 times above sensory threshold 
 Duration of stimulation per session: 15 minutes 
 Placement: site of tenderness and opposite site 
 Electrodes: 2 disposable electrodes different in size, 809 mm2 and 5688 mm2
Outcomes Extracted pain outcome: global pain after 10 weeks, described as "Pain intensity (VAS)" 
 Extracted function outcome: WOMAC global scale after 10 weeks (VAS)
Primary outcomes: pain intensity, WOMAC global scale
Notes *The investigators used the label TENS in their report, but from their description of the intervention it was clear that interferential current stimulation was applied
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Low risk Computer generated block randomisation. Quote "According to a block randomised allocation table (generated by Sample Size, version 2.0, Int), the enrolled patients were allocated to (1) the control (CT) group, (2) the acupuncture (ACP) group, (3) the transcutaneous electrical nerve stimulation (TENS) group or (4) the acupuncture and TENS (A&T) group."
Allocation concealment? Unclear risk No information provided
Free of selective reporting? Unclear risk Insufficient information provided, no access to study protocol
Adequate blinding of patients? High risk No sham intervention
Incomplete outcome reporting: intention‐to‐treat analysis performed? 
 Pain High risk 12 out of 16 (75%) randomised to experimental and 12 out of 16 (75%) randomised to control group were analysed
Incomplete outcome reporting: intention‐to‐treat analysis performed? 
 Function High risk See above
Funding by commercial organisation avoided? Unclear risk No information provided
Funding by non‐profit organisation? Unclear risk No information provided