From analyses of individual patient data ( seven studies , 918 patients ) , we found baseline pain strongly associated with absolute , but not relative , MCID as patients with higher baseline pain needed larger pain reduction to perceive relief .
Conclusions The MCID in acute pain varied greatly between studies and was influenced by baseline pain , definitions of improved patients and study design .
Background The minimum clinical ly important difference ( MCID ) is used to interpret the clinical relevance of results reported by trials and meta-analyses as well as to plan sample sizes in new studies .
However , there is a lack of consensus about the size of MCID in acute pain , which is a core symptom affecting patients across many clinical conditions .
Randomized controlled noninferiority trial to compare extended release acetaminophen and ibuprofen for the treatment of ankle sprains.
STUDY OBJECTIVE To compare acetaminophen extended release 1,300 mg 3 times daily and ibuprofen 400 mg 3 times daily for treatment of signs and symptoms of grade I or II lateral ankle sprains . METHODS Patients ( N=260 ) 18 years or older and with grade I or II lateral ankle sprains were r and omized to receive acetaminophen extended release 1,300 mg 3 times daily or ibuprofen 400 mg 3 times daily for 9 days . Primary endpoint was change from baseline at day 4 in pain on walking . Other endpoints included change from baseline at day 9 in pain on walking ; change from baseline at days 4 and 9 in ability to walk and ankle swelling , bruising , and range of motion ; satisfaction with treatment on days 4 and 9 ; percentage of patients with positive anterior drawer test on day 4 ; and time to resume normal activity . Safety assessment s consisted of reported adverse events . This study had a noninferiority design in which the hypothesis was that acetaminophen extended release was not inferior to ibuprofen for treatment of signs and symptoms of grade I or II lateral ankle sprains . RESULTS The difference in least squares means  ( acetaminophen extended release , ibuprofen ) with respect to the primary endpoint within the per- protocol population was -0.88 ; acetaminophen extended release was comparable to ibuprofen for the primary endpoint because the upper limit ( 3.26 ) of the 1-sided 95 % confidence interval ( CI ) for the difference in least squares means did not exceed the noninferiority limit of 6.90 . The intention-to-treat population was used to test the second step of the 2-step testing process because the null hypothesis was rejected in the noninferiority test . For this analysis , the difference between acetaminophen extended release and ibuprofen in the least squares mean change from baseline for the primary endpoint was -1.63 ( not significant ) . Results showed that acetaminophen extended release was noninferior to ibuprofen  with respect to the secondary endpoints . No serious drug-related adverse events were reported . The most common adverse events , reported by 6.5 % of patients , were in the gastrointestinal system ( mainly nausea and upper abdominal pain ) . CONCLUSION Acetaminophen extended release 3,900 mg daily was comparable to ibuprofen 1,200 mg daily for treatment of grade I or II lateral ankle sprains . Both treatments were well tolerated
From analyses of individual patient data ( seven studies , 918 patients ) , we found baseline pain strongly associated with absolute , but not relative , MCID as patients with higher baseline pain needed larger pain reduction to perceive relief .
Conclusions The MCID in acute pain varied greatly between studies and was influenced by baseline pain , definitions of improved patients and study design .
Background The minimum clinical ly important difference ( MCID ) is used to interpret the clinical relevance of results reported by trials and meta-analyses as well as to plan sample sizes in new studies .
However , there is a lack of consensus about the size of MCID in acute pain , which is a core symptom affecting patients across many clinical conditions .