| Methods |
Design: three group parallel trial
Purpose: study the effect of insertion of intradermal needles into painful points on intractable scar pain |
| Participants |
Patients: out‐patients with intractable abdominal scar pain
Baseline comparability: yes |
| Interventions |
Placebo: intradermal needling into nonpainful points
Untreated: no needling
Experimental: intradermal needling into painful points
(Co‐intervention: diclofenac until 24 hours before pain evaluation) |
| Outcomes |
Number of analgesic tablets per week
Proportion of patients with global pain relief (50% reduction or more)
Pain, continuous (VAS)
Pain, lancinating (VAS)
Pain area (square cm)
Threshold pressure |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
'random number table' |
| Allocation concealment? |
Low risk |
'sequentially sealed opaque envelopes' |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/needling into painful points) |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| 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? |
High risk |
N = 47 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
