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) |
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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 |
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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 |