Supplemental Digital Content 3. Deviations from the study protocol
Protocol Method Deviation from protocol method with justification The main outcomes proposed for
assessment were changes in pain intensity and disability. We planned to assess changes in additional outcomes including quality of life, psychological and cognitive function, work status, healthcare utilisation, patient satisfaction, global
impression of change and incidence of adverse events.
Only data related to the main outcomes, changes in pain intensity and disability are reported. We did not undertake analyses of the additional outcomes due to inconsistency in reporting of these outcomes and a high level of variability in the choice of the outcome measures used to assess these outcomes.
Type of deviation: omission We planned to assess risk of bias
(quality) using the Cochrane
collaboration’s tool for assessing risk of bias in randomised controlled trials
In addition to the risk of bias assessment, we used the GRADE approach (Grading of
Recommendations, Assessment, Development and Evaluations). This approach is recommended by the Cochrane collaboration for appraising the quality/certainty of the evidence.
Type of deviation: addition
