Our review revealed a great heterogeneity in definition , format , and values of what is considered a clinical ly relevant difference in pain in RCTs of analgesics , and st and ardizations are advisable
OBJECTIVE To describe the  pain decrease considered as clinical ly relevant when design ing a trial and reporting its results .
Transdermal fentanyl for improvement of pain and functioning in osteoarthritis: a randomized, placebo-controlled trial.
OBJECTIVE Although common treatments for osteoarthritis ( OA ) pain , such as nonsteroidal antiinflammatory drugs ( NSAIDs ) , simple analgesics , and weak opioids , provide relief in some cases , they fail to control pain or are poorly tolerated in many cases . Strong opioids have been used to successfully treat several types of noncancer pain but have rarely been tested in controlled studies . Therefore , we tested the effects of transdermal fentanyl ( TDF ) in patients with moderate-to-severe OA pain , in a placebo-controlled study . METHODS The cohort comprised patients with radiologically confirmed OA of the hip or knee ( meeting the American College of Rheumatology criteria ) requiring joint replacement and with moderate-to-severe pain that had been inadequately controlled by weak opioids . The patients were r and omized to receive TDF or placebo for 6 weeks after a 1-week pretreatment run-in phase . During study treatment , previously prescribed NSAIDs and simple analgesics were continued , but weak opioids were discontinued . All patients had access to paracetamol and metoclopramide . Pain was recorded on a visual analog scale ( VAS ) , and function was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . RESULTS Data were available for 399 patients ( 202 receiving TDF , 197 receiving placebo ) , of whom 199 ( 50 % ) completed the study . TDF provided significantly better pain relief than placebo , as demonstrated by the primary outcome measure ( area under the curve for VAS scores -20 in the TDF group versus -14.6 in the placebo group ; P = 0.007 ) . TDF was also associated with significantly better overall WOMAC scores and pain scores . The most common adverse events were nausea , vomiting , and somnolence , and these occurred more often in the TDF group . CONCLUSION TDF can reduce pain and improve function in patients with knee or hip OA
Our review revealed a great heterogeneity in definition , format , and values of what is considered a clinical ly relevant difference in pain in RCTs of analgesics , and st and ardizations are advisable
OBJECTIVE To describe the  pain decrease considered as clinical ly relevant when design ing a trial and reporting its results .