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 |
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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 |
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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 |