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 .
Intramuscular Electrical Stimulation for Hemiplegic Shoulder Pain: A 12-Month Follow-Up of a Multiple-Center, Randomized Clinical Trial
Chae J , Yu DT , Walker ME , Kirsteins A , Elovic EP , Flanagan SR , Harvey RL , Zorowitz RD , Frost FS , Grill JH , Fang ZP : Intramuscular electrical stimulation for hemiplegic shoulder pain : A 12-month follow-up of a multiple-center , r and omized clinical trial . Am J Phys Med Rehabil 2005;84:832–842 . Objective : Assess the effectiveness of intramuscular electrical stimulation in reducing hemiplegic shoulder pain at 12 mos posttreatment . Design : A total of 61 chronic stroke survivors with shoulder pain and subluxation participated in this multiple-center , single-blinded , r and omized clinical trial . Treatment subjects received intramuscular electrical stimulation to the supraspinatus , posterior deltoid , middle deltoid , and upper trapezius for 6 hrs/day for 6 wks . Control subjects were treated with a cuff-type sling for 6 wks . Brief Pain Inventory question 12 , an 11-point numeric rating scale was administered in a blinded manner at baseline , end of treatment , and at 3 , 6 , and 12 mos posttreatment . Treatment success was defined as a minimum 2-point reduction in Brief Pain Inventory question 12 at all posttreatment assessment s. Secondary measures included pain-related quality of life ( Brief Pain Inventory question 23 ) , subluxation , motor impairment , range of motion , spasticity , and activity limitation . Results : The electrical stimulation group exhibited a significantly higher success rate than controls ( 63 % vs. 21 % , P = 0.001 ) . Repeated-measure analysis of variance revealed significant treatment effects on posttreatment Brief Pain Inventory question 12 ( F = 21.2 , P < 0.001 ) and Brief Pain Inventory question 23 ( F = 8.3 , P < 0.001 ) . Treatment effects on other secondary measures were not significant . Conclusions : Intramuscular electrical stimulation reduces hemiplegic shoulder pain , and the effect is maintained for ≥12 mos posttreatment
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 .