| Methods |
Design: six group parallel trial
Purpose: study the effect of segmental versus innocuous electrical stimulation for chronic pain relief |
| Participants |
Patients: out‐patients needing screening flexible endoscopy
Baseline comparability: yes (age, gender) |
| Interventions |
Placebo: stimulation with interferential current (IF) device off
Untreated: no IF device treatment
Experimental: stimulation with IF device on
(Co‐intervention: analgesic medication. Patients were asked not to change regime during the study) |
| Outcomes |
Pain (VAS)
Pain relief (%)
Morning stiffness (VAS)
Range of motion (Goniometry)
Pain threshold |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/electrical stimulus device) |
| 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? |
High risk |
N = 17 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
