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

Law 2004a.

Methods Randomised controlled trial 
 2‐arm parallel group design 
 Trial duration: 2 weeks 
 Unstratified randomisation 
 Multicentre trial with 2 centres 
 No power calculation reported
Participants 39 patients randomised 
 39 patients with knee OA reported at baseline 
 Study joints: 39 knees 
 Number of females: 37 of 39 (95%) 
 Average age: 75 years 
 Average BMI: 27 kg/m2 
 Average disease duration: 7.6 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: ITO model 120Z (dual channel) 
 Self‐administered: no 
 Waveform: unclear 
 Pulse width: 200 µsec 
 Pulse frequency: 100 Hz 
 Amplitude: above sensory threshold, up to a comfortable level, range 25‐35 mA 
 Duration of stimulation per session: 40 minutes 
 Electrodes: 4 rubber electrodes, 4.5 x 3.8 cm2 
 Placement: acupuncture points: ST35, LE4, SP9, GB34
Outcomes Extracted pain outcome: pain on walking after 2 weeks, described as "intensity of pain felt while walking (VAS)"** 
 Extracted function outcome: walking disability after 2 weeks, described as "Timed‐Up‐and‐Go test over 3 meters (seconds)"
No primary outcome reported
Notes **Only baseline values reported in the report. Contact established with investigators Law and Cheing, who provided end of treatment and follow‐up data.
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Low risk Quote: "'by drawing lots from the randomization envelope without replacement"
Allocation concealment? Unclear risk Quote : "(...) carried out by physiotherapists who performed the treatment"
Free of selective reporting? High risk No results reported for some outcomes mentioned in the methods section, including pain intensity on VAS
Adequate blinding of patients? Low risk Use of sham device: ITO model 120Z, no current delivered but flashing light on. Quote: "The assessors and subjects were blind to the group allocation. All subjects were told that when the indicator light of the TENS was blinking, it meant the machine was working properly. They might or might not feel any tingling sensation during treatment because the intensity of the current was small."
Incomplete outcome reporting: intention‐to‐treat analysis performed? 
 Pain High risk In total, 3 patients dropped out and were excluded from analysis, as indicated by Gladys Cheing and Pearl Law in personal communication
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