Kim 2012.
Study characteristics | ||
Methods |
Type of study: single‐blind, placebo‐controlled RCT. Condition and number of participants randomised: 100 patients undergoing plastic surgery. Groups: 2 groups: active TENS (N = 50); placebo TENS (N = 50). |
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Participants |
Demographics: N = 100; TENS group 21 male/29 female; age 48.2 yrs ± 13.0; placebo group 19 male/31 female; age 51.2 yrs ± 11.7. Setting: Hospital outpatient, Korea. Inclusion: patients undergoing plastic surgery. Exclusion: concomitant sedative or analgesic medication and neurological disease, or potentially serious internal diseases (ASA physical status > 3). Withdrawals/dropouts: none. |
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Interventions |
Where applied: radial side of the dominant forearm ‐ cathode over cephalic vein 1cm proximal to radial styloid process; anode 3 cm away proximal to cathode. Applied by: anaesthesiologist. Waveform: not stated. Frequency: 80Hz. Pulse duration: 200 μs. Pulse amplitude/Intensity: maximum tolerable level below pain threshold without noticeable muscle contraction. Placebo TENS Group: TENS device without current output but with power indicator light illuminated. Control Group: none. Electrodes: 2 TensCare electrodes, 5 cm² Duration and frequency of Rx: 20 minutes immediately prior to venous cannulation. 1 single Rx. Device/manufacturer: select TENS unit (Empi, St Paul, Minnesota). Adverse effects: itching and erythema reported. |
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Outcomes |
Pain outcome: pain incidence; VAS scores. ITT/per protocol analysis: not stated. Statistical analysis: pain incidence was similar between the 2 groups (P > 0.05); 45 (90%) in the TENS group experienced pain against 50 (100%) in the placebo group using the X² test or Fisher exact test. Pain intensity (VAS) in TENS group was significantly lower than placebo, with TENS VAS scores 1.9 ± 1.2 (P < 0.01) against placebo VAS scores 4.8 ± 1.5 using Wlcoxon rank sum test with continuity correction. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details provided. |
Allocation concealment (selection bias) | Unclear risk | No details provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not stated but no withdrawals/dropouts reported. |
Source of funding bias | Low risk | No apparent funding bias. |
Blinding (Participant) | Low risk | Placebo tens applied to blind participants. |
Blinding (Outcome Assessor) | Low risk | "study‐blinded anaesthesiologist". |
Sample Size | Unclear risk | TENS (N = 50); placebo TENS (N = 50). |