failed composite endpoint of pain and function across entire study but for patients of less than 5 years (the median duration of the study) they had increased outcomes in the primary endpoint.
so even with pain and function primary, receiving therapy earlier in disease progress we may have still met primary.
however, current study doesn't even require functional inprovement. and we know pain improved across all subjects even if later than 5 years.
so they probably dont even have to limit the study to 5 years maximum but i suspect they will. increasing the chances of success even further.
couple of potential issues i was thinking is allot of back pain cases could have been work related. i wonder if they admitted their function improved, they might be worried they'll be told they can go back to work.
also wonder if they'll be told to continue opiods this time or if they will be given the suggestion to try reducing or stopping if possible. issue being the addiction may hide the true opioid sparing potential.
anyway it's fortunate we are not relying on either of these two measures in current trial.
significant durable pain reduction at 12 months with single injection.
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