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 |
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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 |
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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 |