Ng 2003.
| Methods | Randomised controlled trial 3‐arm parallel group design Trial duration: 4 weeks Unstratified randomisation No power calculation reported | |
| Participants | 24 patients randomised 24 patients with knee OA reported at baseline Study joints: 24 knees Number of females: 23 of 24 (96%) Average age: 85 years | |
| Interventions | Experimental intervention: TENS, 4 times per week, with a total of 8 applications and educational pamphlet
Control intervention: educational pamphlet
Duration of treatment period: 2 weeks
Unclear whether analgesics were allowed and whether intake was similar between groups Device: ITO model F‐2 (dual channel) Self‐administered: no Waveform: unclear Pulse width: 200 µsec Pulse frequency: 2 Hz Amplitude: above sensory threshold, until strong, tolerable, stroking sensation, preferably evoking phasic muscle contraction Duration of stimulation per session: 20 minutes Electrode placement: acupuncture points ST35, EX‐LE‐4 Electrodes: 50 x 35 mm2 |
|
| Outcomes | Extracted pain outcome: global pain after 4 weeks, described as "pain (Numeric rating scale (NRS))"
No function outcome reported No primary outcome reported |
|
| Notes | 2 out of 3 trial arms qualified for inclusion in this review | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | Drawing lots. Quote: "Subjects were randomly assigned by drawing a piece of paper that designated each person to the EA, TENS, and control groups" |
| Allocation concealment? | Unclear risk | No information provided |
| Free of selective reporting? | Low risk | Quote: "In each evaluation session, three outcome measures were collected." The authors present results of all these 3 outcomes. |
| Adequate blinding of patients? | High risk | No sham intervention |
| Incomplete outcome reporting: intention‐to‐treat analysis performed? Pain | Unclear risk | No information provided |
| 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 |