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 |
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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 |
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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 Pain | High risk | Investigators reported that "no subject was withdrawn either active or placebo groups".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 |