Cheing 2003.
Methods | Randomised controlled trial 4‐arm parallel group design Trial duration: 4 weeks Randomisation stratified according to gender No power calculation reported | |
Participants | 40 patients randomised 38 patients with knee OA reported at baseline Study joints: 38 knees Number of females: 34 of 38 (89%) Average age: 66 years | |
Interventions | Experimental intervention: 20 min TENS in group 1, 40 min TENS in group 2, 60 min TENS in group 4, 5 times per week
Control intervention: sham TENS, 5 times per week
Duration of treatment period: 2 weeks
Unclear whether analgesics were allowed and whether intake was similar between groups Device: ITO 120Z TENS (dual channel) Self‐administered: no Waveform: not reported Pulse width: 200 µsec Pulse frequency: 100 Hz Amplitude: above sensory threshold, strong but comfortable Duration of stimulation per session: 20 minutes Electrodes: 4 of 2 x 3 cm rubber electrodes Placement: 4 acupuncture points extra 31,32, ST35, GB34, SP9 |
|
Outcomes | Extracted pain outcome: pain on walking after 4 weeks, described as "pain during walking (VAS)"
No function outcome reported No primary outcome reported |
|
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | No information provided |
Allocation concealment? | Unclear risk | No information provided |
Free of selective reporting? | Unclear risk | Trial protocol not accessible, methods section not explicit about pre‐specified outcomes |
Adequate blinding of patients? | Low risk | Sham device: electronic circuit disconnected, no current passed, but indicator light on |
Incomplete outcome reporting: intention‐to‐treat analysis performed? Pain | High risk | 30 out of 30 (100%) randomised to experimental and 8 out of 10 (80%) randomised to control group were analysed |
Incomplete outcome reporting: intention‐to‐treat analysis performed? Function | Unclear risk | Not applicable |
Funding by commercial organisation avoided? | Unclear risk | No information provided |
Funding by non‐profit organisation? | Unclear risk | No information provided |