| Methods |
Design: three group parallel trial
Purpose: examine the prophylactic effect of physical exercise and advice on daily living on recurrence of acute low back pain |
| Participants |
Patients: out‐patients visiting a GP with acute low back pain
Baseline comparability: yes |
| Interventions |
Placebo: sessions with ultrasound at lowest possible frequency
Untreated: no sessions (standard therapy)
Experimental: sessions with exercise and advice on daily living
(Co‐intervention: analgesics on demand, dose NS) |
| Outcomes |
Number of patients with recurrent low back pain episodes
Duration of recurrent low back pain episodes
Functional health status
Mobility problems
Influence on daily life
In‐between consultation of the GP |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Low risk |
'sealed envelope' |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/exercise) |
| 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 (binary outcome) |
| Trial size > 49? |
Low risk |
N = 317 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
Low risk |
All three categories fulfilled |
