Grimmer 1992.
Methods | Randomised controlled trial 3‐arm parallel group design Trial duration: 1 day No power calculation reported | |
Participants | 60 patients randomised 60 patients with knee OA reported at baseline Study joints: 60 knees Number of females: 37 of 60 (62%) Average age: 66 years | |
Interventions | Experimental intervention: high frequency TENS, once only in group 1, burst TENS, once only in group 2
Control intervention: sham TENS, once only
Duration of treatment period: 1 day
Analgesics not allowed Device: Medtronic Neuromed Selectra (dual channel) Self‐administered: no Waveform: unclear Pulse width: unclear Pulse frequency: 80 Hz in group 1, 3 Hz trains of 7 80 Hz pulses in group 2 Amplitude: above sensory threshold, strong tolerable tingling paraesthesia Duration of stimulation per session: 30 minutes Electrodes: 4 carbon rubber silicone electrodes, 2 x 3 cm Placement: 4 acupuncture points around the knee: medial (SP9), lateral (GB33), posterior (UB40), anterior (SP10) |
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Outcomes | Extracted pain outcome: global pain immediately after first and only application, described as "Immediate pain relief (VAS)"
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 | Quote: "randomly allocated (by dice) into three groups of 20" |
Allocation concealment? | Low risk | By a person independent of the study |
Free of selective reporting? | Unclear risk | Insufficient information provided; no access to study protocol |
Adequate blinding of patients? | Low risk | Sham device: Medtronic Neuromed Selectra, with non‐functioning leads. Patient were told that a very high frequency current was being tested and that no skin sensation would be felt. |
Incomplete outcome reporting: intention‐to‐treat analysis performed? Pain | Low risk | Degrees of freedom reported indicate that all randomised patients were included in the analysis |
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 |