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 |