The allocation was based on computer randomization
in blocks of 10 patients, to either integrated
programme or standard programme. Information
on intervention or routine procedure was enclosed
in sealed opaque envelopes with consecutive numbers.
The randomization was performed by a
health professional, which did not otherwise take
part in the trial. The randomized study design
included several pragmatic aspects that relate to
effectiveness, rather than explanatory (efficacy)
trials,12,13 such as measuring health outcomes
(functionality and quality of life), having a relatively
long study duration, testing clinically relevant
treatment modalities, assessing adverse events
and performing intention to treat analyses