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

Fargas‐Babjak 1989.

Methods Randomised controlled trial 
 2‐arm parallel group design 
 Trial duration: 13 weeks 
 No power calculation reported
Participants 56 patients randomised 
 56 patients with knee OA reported at baseline 
 Study joints: 56 joints, most likely > 75% knees 
 Average age; gender, BMI: not reported
Interventions Experimental intervention: burst TENS, twice per day 
 Control intervention: sham TENS, twice per day 
 Duration of treatment period: 6 weeks 
 Analgesics allowed, but change of dosage prohibited. Unclear whether analgesics were assessed and whether intake was similar between groups.
Device: Codetron 
 Self‐administered: yes 
 Waveform: square 
 Pulse width: 1000 µsec 
 Pulse frequency: 200 Hz, train length of 125 ms, repetition frequency of 4 Hz (25 pulses per train) 
 Amplitude: above sensory threshold, highest intensity that could be tolerated without inducing frank pain 
 Duration of stimulation per session: 30 minutes 
 Electrodes: 7 carbon rubber (self‐adhesive) Karaya Pads electrodes of 2 x 3 cm 
 Placement: 10 acupuncture points: GV14, GV4, GB30, GB34, SP13, B1 60, ST36, B1 40, SP9, LI4 and 3 extra tender points
Outcomes Extracted pain outcome: global pain after 13 weeks described as "Pain improvement (percentage pain improvement based on VAS)" 
 No function outcome reported
No primary outcome reported
Notes *Investigators named their intervention AL‐TENS, but we coded it burst TENS in the analyses
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? High risk Quote: "Full details of this (Percent Improvement Pain Scale) are reported elsewhere". Investigators however failed to provide reference.
Adequate blinding of patients? Low risk Use of sham device: Codetron, identical in appearance, set at frequency of 0.2 Hz with a threshold electrical stimulus of 0.5 mA, which caused a sensation on the skin but failed causing the deep muscle afferent stimulation
Incomplete outcome reporting: intention‐to‐treat analysis performed? 
 Pain High risk 56 patients randomised but only 19 analysed in the experimental, and 18 analysed in the control group
Incomplete outcome reporting: intention‐to‐treat analysis performed? 
 Function Unclear risk Not applicable
Funding by commercial organisation avoided? High risk Sponsor: Electronic Health Machines
Funding by non‐profit organisation? Low risk NRC grant no: 689