Methods |
Design: three group parallel trial
Purpose: study the effect of physiotherapy |
Participants |
Out‐patients having had a disc herniation operation
Baseline comparability: yes (except for body mass index) |
Interventions |
Placebo: sessions with neck massage
Untreated: no sessions
Experimental: sessions with physiotherapy‐based rehabilitation
(Co‐intervention: yes) |
Outcomes |
Low Back Pain Rating Scale
Overall satisfaction
Socioeconomic parameters
State Trait Anxiety Inventory |
Notes |
SDs were obtained from the reported CIs |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Low risk |
‘block randomization (SAS) was performed by the Department of Medical Statistics’ |
Allocation concealment? |
Low risk |
'sequentially numbered, sealed opaque envelopes' |
Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/physiotherapy) |
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? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
Trial size > 49? |
Low risk |
N = 80 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
Low risk |
All three categories fulfilled |