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

Law 2004.

Methods Randomised controlled trial 
 4‐arm parallel group design 
 Trial duration: 4 weeks 
 No power calculation reported
Participants 36 patients randomised 
 36 patients with knee OA reported at baseline 
 Study joints: 48 knees* 
 Number of females: 35 of 36 (97%) 
 Average age: 82 years
Interventions Experimental intervention: 2 Hz TENS in group 1, 100 Hz TENS in group 2, modulation TENS with alternations between 2 to 100 Hz in group 3, 5 times per week in all groups 
 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: Han Acupoint Nerve Stimulation LH204H 
 Self‐administered: no 
 Waveform: unclear 
 Pulse width and frequency: 576 µsec and 2 Hz in group 1, 200 µsec and 100 Hz in group 2, 576/200 µsec and 2/100 Hz alternation in group 3 
 Amplitude: above sensory threshold, up to comfortable level, range 25 to 35 mA 
 Duration of stimulation per session: 40 minutes 
 Electrodes: 4 rubber electrodes of 4.5 x 3.8 cm 
 Placement: 4 acupuncture points: ST35, LE4, SP9, GB34
Outcomes Extracted pain outcome: pain on walking after 4 weeks, described as "intensity of pain felt while walking (VAS)" 
 No function outcome reported
No primary outcome reported
Notes Outcome data were reported on knee level.
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Low risk Quote: "Randomization was carried out by drawing lots from the randomization envelope."
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? Low risk Use of sham device: identical in appearance, internal circuit disconnected, no current passed, indicator light on, digital display of intensity control functioned normally. Quote: "Only therapists who administered treatment to the subjects knew the group allocation, while the subjects and the assessor were not given this information."
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 Unclear risk Not applicable
Funding by commercial organisation avoided? Unclear risk No information provided
Funding by non‐profit organisation? Unclear risk No information provided