| Methods |
Design: three group parallel trial
Purpose: examine the effect of transcutaneous electrical nerve stimulation (TENS) on acute pain associated with wound dressing |
| Participants |
Patients: postoperative patients needing surgical wound dressing.
Baseline comparability: NS |
| Interventions |
Placebo: TENS with no current passing to electrodes
Untreated: no TENS
Experimental: TENS with current passing to electrodes
(Co‐intervention: analgesics administered at the same rate for all groups) |
| Outcomes |
Pain (VAS) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'...the experimenter was unaware of the assigned intervention during the initial preparation of each subject for the study' |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
Low risk |
N = 50 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |
