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

Yurtkuran 1999.

Methods Randomised controlled trial 
 4‐arm parallel group design 
 Trial duration: 2 weeks 
 No power calculation reported
Participants 100 patients randomised, 25 per group 
 100 patients with knee OA reported at baseline 
 Study joints: 100 knees 
 Number of females: 91 of 100 (91%) 
 Average age: 58 years
Interventions Experimental intervention: TENS, 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: MEA‐TENS (dual channel) 
 Self‐administered: no 
 Waveform: rectangular 
 Pulse width: 1000 µsec 
 Pulse frequency: 4 Hz* 
 Amplitude: above sensory threshold, up to muscle contraction, just below pain tolerance threshold 
 Duration of stimulation per session: 20 minutes 
 Electrodes: 4 small MEA rubber electrodes 
 Placement: 4 acupuncture points SP‐9, GB‐34, ST‐34, ST‐35
Outcomes Extracted pain outcome: global pain after 2 weeks described as "Overall present pain intensity at rest (Likert)" 
 Extracted function outcome: walking disability after 2 weeks, described as "50 foot walking time (in minutes)"
No primary outcome reported
Notes Two out of 4 groups, the electroacupuncture and ice massage groups, were excluded in this review. *Investigators named their intervention AL‐TENS, but we coded it low frequency TENS in our analysis.
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: MEA‐TENS with broken lead at jack plug, no current passed but red indicator light on. Quote: "(...) treatment appeared to be done in the same way as the other groups without the subjects suspecting the nature of the stimulation".
Incomplete outcome reporting: intention‐to‐treat analysis performed? 
 Pain High risk Investigators reported that "no subject was withdrawn either active or placebo groups". However, the reported degrees of freedom indicate that 5 out of 100 patients were not included. It remained unclear to which of the 4 groups the excluded patients belonged.
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