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

Cheing 2002.

Methods Randomised controlled trial 
 4‐arm parallel group design 
 Trial duration: 8 weeks 
 Randomisation stratified according to age, gender, BMI 
 No power calculation reported
Participants 66 patients randomised 
 62 patients with knee OA reported at baseline 
 Study joints: 62 knees 
 Number of females: 53 of 62 (85%) 
 Average age: 64 years 
 Average BMI: 28 kg/m2
Interventions Comparison 1 
 Experimental intervention: 60 min TENS, 5 times per week 
 Control intervention: sham TENS, 5 times per week
Comparison 2 
 Experimental intervention: TENS plus exercise, 5 times per week 
 Control intervention: exercise alone, 5 times per week
Duration of treatment period: 4 weeks 
 Analgesics allowed, unclear whether intake was similar between groups
Device: MAXIMA III (dual channel) 
 Self‐administered: unclear, most likely not 
 Waveform: square 
 Pulse width: 140 µsec 
 Pulse frequency: 80 Hz 
 Amplitude: above sensory threshold, tingling sensation, 3 to 4 times above sensory threshold 
 Duration of stimulation per session: 60 minutes 
 Electrodes: 4 electrodes of 4 x 4 cm 
 Placement: at acupuncture points: ST35, SP9, GB34, extra 31,32 (one electrode covering both extra 32 and ST35)
Outcomes Extracted pain outcome: global pain after 8 weeks, described as "Intensity of subjective pain sensation (Baseline score on 0‐10 cm VAS was standardised to be 100% in each of the groups. Follow up values were expressed as mean decrease in % from baseline)". 
 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 Comparison 1: Yes, sham device identical in appearance to real TENS unit, no current passed but indicator light was lit up Comparison 2: No, no sham intervention
Incomplete outcome reporting: intention‐to‐treat analysis performed? 
 Pain High risk Comparison 1: 16 out of 16 (100%) randomised to experimental and 16 out of 18 (89%) randomised to control group were analysed 
 Comparison 2: 15 out of 17 (88%) randomised to experimental and 15 out of 15 (100%) 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