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 .
Treatment of lateral epicondylitis with botulinum toxin: a randomized, double-blind, placebo-controlled trial.
BACKGROUND Lateral epicondylitis is a common condition for which botulinum toxin has been reported to have a therapeutic role in uncontrolled studies . OBJECTIVE To determine if an injection of botulinum toxin is more effective than placebo for reducing pain in adults with lateral epicondylitis . DESIGN R and omized , double-blind , placebo-controlled trial conducted from September 2002 to December 2004 . SETTING Outpatient clinics at a university hospital and a district hospital in Hong Kong . PARTICIPANTS 60 patients with lateral epicondylitis . MEASUREMENTS The primary outcome was change in subjective pain as measured by a 100-mm visual analogue scale ( VAS ) ranging from 0 ( no pain ) to 10 ( worst pain ever ) at 4 weeks and 12 weeks . All patients completed post-treatment follow-up . INTERVENTIONS A single injection of 60 units of botulinum toxin type A or normal saline placebo . RESULTS Mean VAS scores for the botulinum group at baseline and at 4 weeks were 65.5 mm and 25.3 mm , respectively ; respective scores for the placebo group were 66.2 mm and 50.5 mm ( between-group difference of changes , 24.4 mm [ 95 % CI , 13.0 to 35.8 mm ] ; P < 0.001 ) . At week 12 , mean VAS scores were 23.5 mm for the botulinum group and 43.5 mm for the placebo group ( between-group difference of changes , 19.3 mm [ CI , 5.6 to 32.9 mm ] ; P = 0.006 ) . Grip strength was not statistically significantly different between groups at any time . Mild paresis of the fingers occurred in 4 patients in the botulinum group at 4 weeks . One patient 's symptoms persisted until week 12 , whereas none of the patients receiving placebo had the same complaint . At 4 weeks , 10 patients in the botulinum group and 6 patients in the placebo group experienced weak finger extension on the same side as the injection site . LIMITATIONS The trial was small , and most participants were women . The blinding protocol may have been ineffective because the 4 participants who experienced paresis of the fingers could have correctly assumed that they received an active treatment . CONCLUSIONS Botulinum toxin injection may improve pain over a 3-month period in some patients with lateral epicondylitis , but injections may be associated with digit paresis and weakness of finger extension
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 .