title: The end of the line? The Visual Analogue Scale and Verbal Numerical Rating Scale as pain assessment tools in the emergency department A Comparison of Change in the 0–10 Numeric Rating Scale to a Pain Relief Scale and Global Medication Performance Scale in a Short-term Clinical Trial of Breakthrough Pain Intensity Identifying the minimum clinically significant difference in acute pain in the elderly. Measurement of health status. Ascertaining the minimal clinically important difference. Concurrent Comparison of Responsiveness in Pain and Functional Status Measurements Used for Patients With Low Back Pain Do 0–10 Numeric Rating Scores Translate into Clinically Meaningful Pain Measures for Children? Clinically significant changes in acute pain in a pediatric ED using the Color Analog Scale. Should study subjects see their previous responses: data from a randomized control trial. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Correlation of change in visual analog scale with pain relief in the ED. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Setting the benchmark for research in the management of acute pain in emergency departments. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain Clinically significant differences in acute pain measured on self-report pain scales in children. Clinically meaningful measurement of pain in children with sickle cell disease. Short-term Effects of High-Intensity Laser Therapy Versus Ultrasound Therapy in the Treatment of People With Subacromial Impingement Syndrome: A Randomized Clinical Trial Problems with measurement of the minimum clinically significant difference in acute pain in elders. Analgesic Effects of EMLA Cream and Oral Sucrose During Venipuncture in Preterm Infants Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Postsurgical pain outcome assessment Validation and properties of the verbal numeric scale in children with acute pain Assessment of clinically significant changes in acute pain in children. Defining substantial clinical benefit following lumbar spine arthrodesis. Determining the minimum clinically significant difference in visual analog pain score for children. Evaluation of clinically relevant states in patient reported outcomes in knee and hip osteoarthritis: the patient acceptable symptom state. Relationship between intensity and relief in patients with acute severe pain. Nebulized fentanyl vs intravenous morphine for ED patients with acute limb pain: a randomized clinical trial. Meaningful cut-off pain intensity for breakthrough pain changes in advanced cancer patients Intravenous acetaminophen for pain after major orthopedic surgery: an expanded analysis. What constitutes a clinically important pain reduction in patients after third molar surgery? Feeling good rather than feeling better matters more to patients. Acetaminophen (paracetamol) improves pain and well-being in people with advanced cancer already receiving a strong opioid regimen: a randomized, double-blind, placebo-controlled cross-over trial. Testing minimal clinically important difference: consensus or conundrum? Do quantitative changes in pain intensity correlate with pain relief and satisfaction? Responsiveness of efficacy endpoints in clinical trials with over the counter analgesics for headache Reliability and validity of a visual analog scale for acute abdominal pain in the ED. Randomized controlled noninferiority trial to compare extended release acetaminophen and ibuprofen for the treatment of ankle sprains. Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial. Corticosteroids in peritonsillar abscess treatment: a blinded placebo-controlled clinical trial.
abstract: Objectives To compare the Visual Analogue Scale ( VAS ) and the Verbal Numerical Rating Scale ( VNRS ) , in the assessment of acute pain in the emergency department ( ED ) . Furthermore , to determine the influence of demographics on this agreement and practical limitations of the scales . Setting St Vincent 's University Hospital , Dublin ; a 479-bed teaching hospital ; annual ED census 36 000 adult patients . Methods A prospect i ve observational study was conducted on ED patients with acute pain as a component of their presenting complaint . Eligible patients scored their pain on both VAS and VNRS within 1 hour of arrival . They rescored their pain every 30 minutes for 2 hours using both scales . The primary outcome measure was agreement between VAS and VNRS .  Secondary outcomes were ease of pain scale use and effect of patient demographics on pain scores . Agreement between scores was evaluated using the Bl and -Altman method . Results 123 patients were included ( median age 35 ; 43.9 % male ) . There was a strong correlation between VAS and VNRS  ( rs=0.93 ) . However , there was not perfect agreement between the two scales . Patient age ( older age , p<0.005 , t=−4.448 ) , gender ( female sex , p<0.005 , t=4.903 ) and educational level attained ( third level education , p<0.005 , t=5.575 ) had a statistically significant influence on the agreement between VAS and VNRS . There was a preference for VNRS in those patients who expressed a preference for one pain scale over the other . Conclusions VAS and VNRS are not interchangeable in assessing an individual patient 's pain over time in the ED setting . VNRS has practical advantages over VAS in this setting Background : Pain intensity is commonly reported using a 0–10 Numeric Rating Scale in pain clinical trials . Analysis of the change on the Pain Intensity Numerical Rating Scale as a proportion has most consistently correlated with clinical ly important differences reported on the patient 's global impression of change . The correlation of data from patients with breakthrough pain with a Pain Relief Scale and a different global outcome measures will extend our underst and ing of these measures . Methods : Data were obtained from the open titration phase of a multiple crossover , r and omized , double-blind clinical trial comparing oral transmucosal fentanyl citrate with immediate-release oral morphine sulfate for the treatment of cancer-related breakthrough pain . Raw and percentage changes in the pain intensity scores from 1,307 episodes of pain in 134 oral transmucosal fentanyl citrate-naïve patients were correlated with the clinical ly relevant secondary outcomes of Pain Relief Verbal Response Scale and the global medication performance scale . The changes in raw and percentage change were assessed over time and compared with the ordinal Pain Relief Verbal Response Scale and Global Medication Performance Scale . Results : The P value of the interaction between the raw pain intensity difference was significant ( P = 0.034 ) for four 15-min time periods but not for the percentage pain intensity difference score ( P = 0.26 ) . We found similar results in comparison with the ordinal Pain Relief Verbal Response Scale ( P = 0.0048 and P = 0.36 respectively ) and global medication performance categories ( P = 0.048 and P = 0.45 , respectively ) . Conclusion : The change in pain intensity in breakthrough pain was more consistent over time and when compared with both the Pain Relief Verbal Response Scale and the Global Medication Performance Scale when the percentage change is used rather than raw pain intensity difference STUDY OBJECTIVE To identify the minimum clinical ly significant difference in pain in elderly emergency department ( ED ) patients . METHODS This was an observational , prospect i ve study of a convenience sample of patients aged 65 years or older with acute pain . Patients rated their pain on an 11-point numeric rating scale ( NRS ) on entering the study and every 30 minutes for 2 hours . The arithmetic minimum clinical ly significant difference was defined as the mean difference between current and preceding NRS scores when the subject described his or her pain as " a little less pain " or " a little more pain . " The proportional minimum clinical ly significant difference was change in NRS in a 30-minute interval divided by the NRS at the beginning of the interval . We used generalized estimating equations to adjust for nonindependence of pain scores and to test trend over time . RESULTS One hundred ninety-five patients were enrolled ( mean age 74 years ; 73 % women ; 51 % Hispanic ; 33 % black ) . The arithmetic minimum clinical ly significant difference averaged over all periods was 1.5 ( 95 % confidence interval 1.3 to 1.6 ) , the proportional minimum clinical ly significant difference was 25 % ( 95 % confidence interval 20 % to 29 % ) . The arithmetic minimum clinical ly significant difference unexpectedly decreased over time : 2.1 from baseline to 30 minutes , 1.4 from 30 to 60 minutes , 1.3 from 60 to 90 minutes , and 1.0 from 90 to 120 minutes ( P<.001 ) . In contrast , the proportional differences were more stable : 27 % from baseline to 30 minutes , 22 % from 30 to 60 minutes , 22 % from 60 to 90 minutes , and 28 % from 90 to 120 minutes ( P=.89 ) . CONCLUSION The arithmetic minimum clinical ly significant difference in older ED patients was 1.5 NRS units and decreased over time , whereas the proportional change was 25 % and more stable In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring  dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials Study Design . Prospect i ve study of two sample s of patients with acute and chronic low back pain , respectively . Objectives . To compare the responsiveness of four functional status question naires , Rol and Morris Disability Question naire ( RMDQ ) ,  Oswestry Disability Index ( ODI ) ,  Disability Rating Index ( DRI ) , and  Physical Functioning scale of the SF-36 ( PFSF-36 ) , and two  pain scales , a  Numerical Pain Rating Scale ( NRS ) and  Visual Analogue Scale ( VAS ) .  Summary of Background Data . Concurrent comparisons of different outcome measurements in back patients have been requested . Methods .  Norwegian versions of the scales and question naires  were completed by 54 patients with acute ( < 3weeks ) and 50 patients with chronic low back pain ( > 3 months ) . Clinical change was estimated on a global change index . An alternative external criterion was the expected clinical course in the two cohorts . Mean changes , st and ardized response mean ( SRM ) , and area under the receiver operating characteristic ( ROC ) curves with cutoff point for highest sensitivity and specificity were calculated . Results . At the follow-up , 63 % of the acute and 41 % of the chronic sample reported improvement on the global change index . Large SRMs ( 1.3–2.0 ) and areas under the ROC curves ( 0.84–0.93 ) were found for the measurements in the acute sample . In the chronic sample , the SRMs ( 0.4–1.1 ) and areas under the ROC curves ( 0.65–0.83 ) were lower , in particular for the PFSF-36 and the VAS . There was no statistically significant difference between the responsiveness in the measurements , except for higher responsiveness in the NRS compared with the VAS when using expected clinical course as the external criterion for change . Conclusion . The results suggest that all the outcome measures were appropriate for measuring changes in functional status and pain in patients with acute low back pain , whereas among chronic patients the RMDQ , ODI , DRI , and NRS were most appropriate BACKGROUND : Self-reported pain scores are used widely in clinical and research setting s , yet little is known about their interpretability in children . In this prospect i ve , observational study we evaluated the relationship between 0 to 10 numerical rating scale ( NRS ) pain scores and other self-reported , clinical ly meaningful outcomes , including perceived need for medicine ( PNM ) , pain relief ( PR ) , and perceived satisfaction ( PS ) with treatment in children postoperatively . METHODS : This study included children ages 7 to 16 years undergoing surgery associated with postoperative pain . One to 4 observations were recorded in each child within the first 24 hours postoperatively . At each assessment , children rated their pain with the NRS , stated their PNM , and rated their satisfaction with  pain management .  Assessment s were repeated within 1 to 2 hours , and children additionally rated their PR as the same , better , or worse in comparison with the earlier assessment . Receiver operator characteristic curves were developed to examine potential NRS cut-points for PNM and PS , and the minimum clinical ly significant difference ( MCSD ) in pain score associated with PR was calculated . RESULTS : Three hundred ninety-seven observations ( including 189 pairs ) were recorded in 113 children .  NRS scores associated with PNM were significantly higher than “ no need ” ( median 6 vs. 3 ; P < 0.001 ) . NRS scores > 4 had good sensitivity ( 0.81 ) and specificity ( 0.70 ) to discriminate PNM , but with a large number of false positives and negatives ( e.g. , 42 % of children with scores > 4 did not need analgesia ) . The MCSD in NRS scores was −1 ( 95 % confidence interval [ CI ] −0.5 to 1 ) or + 1 ( CI 0.5 to 2.7 ) in relation to feel “ a little better ” or “ worse , ” respectively ( P < 0.001 vs. the same ) . NRS scores > 6 had a sensitivity of 0.82 and specificity of 0.76 in discriminating dissatisfaction with treatment , yet 46 % and 24 % of children with scores > 6 , respectively , were somewhat to very satisfied with their analgesia . CONCLUSIONS : This study provides important information regarding the clinical interpretation of NRS pain scores in children . Data further support the NRS as a valid measure of pain intensity in relation to the child 's PNM , PR , and PS in the acute postoperative setting . However , the variability in scores in relation to other clinical ly meaningful outcomes suggests that application of cut-points for individual treatment decisions is inappropriate OBJECTIVE The purpose of this study is to quantify , using the  Color Analog Scale ( CAS ) , the degree of change in pain severity required to achieve a clinical ly significant improvement in pain . METHODS A prospect i ve descriptive study , using convenience sampling of children aged 5 and 12 years presenting to a pediatric emergency department ( ED ) with acute pain , was done . Children were asked to mark their pain severity on a previously vali date d CAS . After a pain intervention , the child was again asked to mark their pain intensity on the CAS and asked to describe the relative change in their pain . The main outcome measure was to quantify the smallest change required for the child to state that their pain was improved . RESULTS One hundred twenty-six children with a mean age of 8.6 years ( SD , 2.8 years ) were enrolled . Males accounted for 56 % . Pain was traumatic in 47.6 % and nontraumatic in 52.4 % . Of the 126 pain comparisons made , 28 children described their pain as " the same " and had a mean change in score of -0.10 cm ( 95 % confidence interval [ CI ] , -2.27 to 2.07 cm ) . Pain was judged to be a " little less " in 58 children , and the CAS score changed by a mean of -2.4 cm ( 95 % CI , -3.15 to -1.72 cm ) . In the 29 children who judged their pain to be " much less , " the CAS score decreased by a mean of -5.4 cm ( 95 % CI , -6.50 to -4.40 ) . CONCLUSION A decrease on the CAS pain scale of 2.4 cm ( 95 % CI , 2.95 - 1.92 ) is a clinical ly significant change in pain for children aged 5 to 12 years with acute pain . The CAS is a valuable tool in assessing responses to pain interventions To test the relative merits of administering question naires with previous responses available ( the informed condition ) or unavailable ( the blind condition ) , we administered blind and informed versions of a quality of life question naire ( the Chronic Respiratory Disease Question naire , or CRQ ) in a r and omized , double-blind trial of bronchodilators in chronic airflow limitation . The responsiveness of the two methods , as reflected in the p-values associated with salbutamol and theophylline effects were comparable for three of the four dimensions of the CRQ . The data suggested possible increased responsiveness of the informed method for the emotional function dimension of the question naire . Changes in the informed CRQ dyspnea and fatigue dimensions showed stronger correlations with changes in spirometry , 6 minute walk distance , and rating of dyspnea after the walk test than did blind administration . Further , changes in all four CRQ dimensions showed stronger correlations with corresponding global ratings using the informed question naire . These results suggest that by letting study subjects see their previous responses the validity of subjective measures of health status in clinical trials can be improved BACKGROUND In a l and mark hypothesis-generating study , Todd et al found that a difference of approximately 13 mm ( 95 % confidence interval [ CI ] 10 to 17 mm ) on a visual analog scale ( VAS ) represented the minimum change in acute pain that was clinical ly significant in a cohort of trauma patients . STUDY OBJECTIVE We test the hypothesis that the minimum clinical ly significant change in pain as measured by the VAS in an independent , more heterogeneous validation cohort is approximately 13 mm . METHODS This was a prospect i ve , observational cohort study of adults presenting to 2 urban emergency departments with pain . At 30-minute intervals during a 2-hour period , patients marked a VAS and were asked if their pain was " much less , " " a little less , " " about the same , " " a little more , " or " much more . " All data were obtained without reference to prior VAS scores . The minimum clinical ly significant change in pain was defined a priori as the difference in millimeters between the current and immediately preceding VAS scores when " a little more " or " a little less pain " was reported . RESULTS Ninety-six patients enrolled in the study , providing 332 paired pain measurements . There were 141 paired measurements design ated by patients as " a little less " or " a little more " pain . The mean clinical ly significant difference between consecutive ratings of pain in the combined " little less " or " little more " groups was 13 mm ( 95 % CI 10 to 16 mm ) . The difference between this finding and that of Todd et al was 0 mm ( 95 % CI -4 to 4 mm ) . CONCLUSION These data are virtually identical to previous findings indicating that a difference of 13 mm on a VAS represents , on average , the minimum change in acute pain that is clinical ly significant OBJECTIVES To evaluate the validity of change in  visual analog Scale ( VAS ) as a measure of pain relief using a verbal descriptor Scale ( VDS ) of change in pain . METHODS A prospect i ve observational study of emergency department patients measured  pain  with  VAS and recorded verbal report of change in pain .  RESULTS One thous and four hundred ninety patients yielded 1999 comparisons between change in VAS and VDS . Correlation of change in VAS and VDS of change in pain was rho = 0.667 ( P < .001 ) . A wide range of change in VAS , large st and ard deviations for the mean change in VAS , and discordance in the direction of change in VAS were present within each verbal descriptor category . CONCLUSIONS Change in VAS is moderately correlated with a VDS of change in pain . Wide variability in change in VAS and discordance with a VDS demonstrate that change in VAS is not a valid indicator of pain relief for individual patients OBJECTIVES To determine the minimum clinical ly significant difference in visual analog scale ( VAS ) pain scores for acute pain in the ED setting and to determine whether this difference varies with gender , age , or cause of pain . METHODS A prospect i ve , descriptive study of 152 adult patients presenting to the ED with acute pain . At presentation and at 20-minute intervals to a maximum of three measurements , patients marked the level of their pain on a 100-mm , nonhatched VAS . At each follow-up they also gave a verbal rating of their pain as " a lot better , " " much the same , " " a little worse , " or " much worse . " The minimum clinical ly significant difference in VAS pain scores was defined as the mean difference between current and preceding scores when pain was reported as a little worse or a little better . Data were compared based on gender , age more than or less than 50 years , and traumatic vs nontraumatic causes of pain . RESULTS The minimum clinical ly significant difference in VAS pain scores is 9 mm ( 95 % CI , 6 to 13 mm ) . There is no statistically significant difference between the minimum clinical ly significant differences in VAS pain scores based on gender ( p=0.172 ) , age ( p=0.782 ) , or cause of pain ( p=0.84 ) . CONCLUSIONS The minimum clinical ly significant difference in VAS pain scores was found to be 9 mm . Differences of less than this amount , even if statistically significant , are unlikely to be of clinical significance . No significant difference in minimum significant VAS scores was found between gender , age , and cause-of-pain groups OBJECTIVE The aim of this study was to define the degree of change on a visual analogue scale that corresponded to a clinical ly meaningful reduction in the level of pain reported by patients experiencing acute pain . METHOD Secondary analysis of data was performed from prospect i ve , descriptive studies of 152 adults and 73 children presenting to emergency departments with acute pain . At presentation and at 20 min intervals to a maximum of three measurements , patients marked the level of their pain on a 100 mm , non-hatched visual analogue scale . At each follow up , they also gave a verbal rating of their pain as ' a lot better ' , ' a little better ' , ' much the same ' , ' a little worse ' or ' much worse ' . Data from the groups reporting that pain was ' a lot better ' and ' about the same ' were analysed for mean and median absolute change in visual analogue scale and compared . RESULTS Of 559 pain comparisons , 60 were rated as ' a lot better ' and 257 as ' about the same ' . The mean absolute change in visual analogue scale for the group reporting that pain was ' a lot better ' was 24 mm ( median = 19 mm , 95 % confidence interval = 17 - 31 mm ) . For the group reporting that pain was ' about the same ' , the mean visual analogue scale change was 0 mm ( median = 0 mm , 95 % confidence interval = -1 to 1 mm ) . CONCLUSION When evaluating treatments for acute pain , a difference in visual analogue scale pain score of less than about 20 mm is unlikely to be clinical ly meaningful . Studies should be design ed and reported relative to this benchmark rather than the minimum clinical ly significant difference in visual analogue scale pain score Objective —To determine whether minimum clinical ly significant difference in visual analogue scale ( VAS ) pain score varies according to the severity of pain reported . Method — Prospect i ve descriptive study of adult patients in an urban emergency department ( ED ) . On presentation to the ED , patients marked the level of their pain on a 100 mm , non-hatched VAS scale . At 20 minute intervals thereafter they were asked to give a verbal categorical rating of their pain as “ a lot better ” , “ a little better ” , “ much the same ” , “ a little worse ” or “ much worse ” and to mark the level of pain on a VAS scale of the same type as used previously . It was pre-defined that patients with VAS pain scores of 30 mm or less would be categorised as having mild pain , those with scores of 70 mm or more were categorised as having severe pain and those from 31 mm to 69 mm , moderate pain . The minimal clinical ly significant difference ( MCSD ) in VAS pain score was defined as the mean difference between current and preceding scores when the subject reported “ a little worse ” or “ a little better ” pain . Results —156 patients were enrolled in the study , yielding 88 evaluable comparisons where pain was rated as “ a little better ” or “ a little worse ” . The MCSD in VAS score in the group overall was 12 mm ( 95%CI 9 mm to 15 mm ) . MCSD in VAS score for the “ mild pain ” group was 11 mm ( 95%CI 4 mm to 18 mm ) , for the “ moderate pain ” group 14 mm ( 95%CI 10 mm to 18 mm ) and for the severe pain group , 10 mm ( 95%CI 6 mm to 14 mm ) . There is no statistical difference between the MCSD in VAS score between the severity groups . Conclusions —The MCSD in VAS pain score does not differ with the severity of pain being experienced OBJECTIVES The objective was to determine the minimum and ideal clinical ly significant differences ( MCSD , ICSD ) in  pain intensity in children for the Faces Pain Scale-Revised ( FPS-R ) and the Color Analog Scale ( CAS ) and to identify any differences in these estimates based on patient characteristics . METHODS This was a prospect i ve study of children aged 4 to 17 years with acute pain presenting to two urban pediatric emergency departments . Participants self-reported their pain intensity using the FPS-R and CAS and qualitatively described their changes in pain . Changes in pain score reported using the FPS-R and CAS that were associated with " a little less " and " much less " pain ( MCSD and ICSD , respectively ) were identified using a receiver operating characteristic-based method and expressed as raw change score and percent reductions . Estimates of MCSD and ICSD were determined for each category of initial pain intensity ( mild , moderate , and severe ) and patient characteristics ( age , sex , and ethnicity ) . Post hoc exploratory analyses evaluated categories of race , primary language , and etiology of pain . RESULTS A total of 314 children with acute pain were enrolled ; mean ( ±SD ) age was 9.8 ( ±3.8 ) years . The FPS-R raw change score and percent reduction MCSD estimates were 2/10 and 25 % , with ICSD estimates of 3/10 and 60 % . For the CAS , raw change score and percent reduction MCSD estimates were 1/10 and 15 % , with ICSD estimates of 2.75/10 and 52 % . For both scales , raw change score and percent reduction estimates of the MCSD remained unchanged in children with either moderate or severe pain . For both scales , estimates of ICSD were not stable across categories of initial pain intensity . There was no difference in MCSD or ICSD based on age , sex , ethnicity , race , primary language , or etiology of pain . CONCLUSIONS The MCSD estimates can be expressed as raw change score and percent reductions for the FPS-R and CAS . These estimates appear stable for children with moderate to severe pain , irrespective of age , sex , and ethnicity . Estimates of ICSD were not stable across different categories of initial pain intensity , therefore limiting their potential generalizability BACKGROUND Limited underst and ing of the interpretability of patient-reported pain scores may impact pain management . The current study assessed the minimal clinical ly significant improvement in pain and pain scores signifying patient-reported need for medication and treatment satisfaction in patients with sickle cell disease ( SCD ) . PROCEDURE Patients , 8 - 18-years-old , with SCD were recruited while receiving treatment for pain .  Patients completed initial pain severity ratings using the Visual Analog Scale ( VAS ) and the Numeric Rating Scale ( NRS ) . Serial assessment s of pain severity , pain relief , perceived need for medication , and treatment satisfaction were completed in the emergency department and the hospitalization . Data were used to calculate the minimal clinical ly significant improvement in pain and pain scores associated with perceived need for pain medication and treatment satisfaction . RESULTS Twenty-eight patients completed 305 assessment s during 37 total visits . A decrease in pain severity score of 0.97 cm for the VAS and 0.9 for the NRS was found to be the minimum clinical ly significant improvement in pain . Pain scores > 7.45 cm on the VAS or 7.5 on the NRS were suggestive of patient-reported need for pain medication . Pain scores < 7.35 cm on the VAS or 8.5 on the NRS were suggestive of patient-reported treatment satisfaction discrimination . CONCLUSIONS The minimal clinical significant improvement was defined for the VAS and NRS and both scales were able to discriminate between important clinical findings including pain relief , need for pain medication , and treatment satisfaction . Collectively , this study provides data to improve our underst and ing of pain ratings of pediatric patients with SCD Background : Subacromial impingement syndrome ( SAIS ) is a painful condition result ing from the entrapment of anatomical structures between the anteroinferior corner of the acromion and the greater tuberosity of the humerus . Objective : The aim of this study was to evaluate the short-term effectiveness of high-intensity laser therapy ( HILT ) versus ultrasound ( US ) therapy in the treatment of SAIS . Design : The study was design ed as a r and omized clinical trial . Setting : The study was conducted in a university hospital . Patients : Seventy patients with SAIS were r and omly assigned to a HILT group or a US therapy group . Intervention : Study participants received 10 treatment sessions of HILT or US therapy over a period of 2 consecutive weeks . Measurements : Outcome measures were the Constant-Murley Scale ( CMS ) , a visual analog scale ( VAS ) , and the Simple Shoulder Test ( SST ) . Results : For the 70 study participants ( 42 women and 28 men ; mean [ SD ] age=54.1 years [ 9.0 ] ; mean [ SD ] VAS score at baseline=6.4 [ 1.7 ] ) , there were no between-group differences at baseline in VAS , CMS , and SST scores . At the end of the 2-week intervention , participants in the HILT group showed a significantly greater decrease in pain than participants in the US therapy group . Statistically significant differences in change in pain , articular movement , functionality , and muscle strength ( force-generating capacity ) ( VAS , CMS , and SST scores ) were observed after 10 treatment sessions from the baseline for participants in the HILT group compared with participants in the US therapy group . In particular , only the difference in change of VAS score between groups ( 1.65 points ) surpassed the accepted minimal clinical ly important difference for this tool . Limitations : This study was limited by sample size , lack of a control or placebo group , and follow-up period . Conclusions : Participants diagnosed with SAIS showed greater reduction in pain and improvement in articular movement functionality and muscle strength of the affected shoulder after 10 treatment sessions of HILT than did participants receiving US therapy over a period of 2 consecutive weeks OBJECTIVES A st and ard value for the minimum clinical ly significant difference ( MCSD ) in pain in nonelderly ED patients has been identified and has facilitated research in this age group . It is not clear that this value is similar in older patients . The st and ard method for calculating the  MCSD  in pain is to average scores on a numerical rating scale ( NRS ) over contiguous time periods . This method is based on the assumption that the MCSD remains constant over time . In an earlier hypothesis-generating study of elderly patients , this assumption was not met for the arithmetic MCSD , making it difficult to identify a single benchmark for measuring efficacy in analgesia trials in elders . The proportional MCSD was more stable , suggesting that it might constitute a better measure of analgesic efficacy in elderly patients . The objective of the study was to test the hypotheses that : 1 ) the arithmetic MCSD in adults 65 years and older declines over time and that 2 ) the proportional MCSD remains constant . METHODS This was an observational , prospect i ve , cohort study of emergency department ( ED ) patients ≥65 years with acute pain . Pain intensity was rated on a st and ard 11-point NRS upon study entry and every 30 minutes for 2 hours . The arithmetic MCSD was defined as the mean change in pain between contiguous 30-minute intervals when change in pain was described as " a little less " or " a little more . " The proportional MCSD was calculated as the arithmetic MCSD divided by pain intensity at the beginning of the interval . We used generalized estimating equations ( GEEs ) to test trend over time . RESULTS A total of 214 patients were enrolled : mean ( ± st and ard deviation [ SD ] ) age was 74 ( ±7.5 ) years , 66 % were female , 63 % were Hispanic , and 23 % were African American .  The median initial NRS was 8 . The MCSD decreased 2.1 NRS units ( 95 % confidence interval [ CI ] = 1.7 to 2.4 ) between 0 and 30 minutes , 1.4 units ( 95 % CI = 1.0 to 1.7 ) between 30 and 60 minutes , 1.3 units ( 95 % CI = 1.0 to 1.5 ) between 60 and 90 minutes , and 0.8 units ( 95 % CI = 0.6 to 1.0 ) between 90 and 120 minutes ( p < 0.001 for trend ) . The proportional MCSD also varied from 27 % ( 95 % CI = 23 % to 32 % ) between 0 and 30 minutes , 19 % ( 95 % CI = 13 % to 24 % ) between 30 and 60 minutes , 22 % ( 95 % CI = 18 % to 27 % ) between 60 and 90 minutes , and 13 % ( 95 % CI = 9 % to 18 % ) between 90 and 120 minutes ( p < 0.001 for trend ) . CONCLUSIONS Both the arithmetic and the proportional MCSD in elderly patients in acute pain declined over time . Because both measures were numerically unstable , there does not appear to be a single value for the MCSD that can be used to identify the MCSD in pain for use in analgesic efficacy trials in elderly patients . A different metric may be needed to study pain and assess comparative analgesic efficacy in elderly patients OBJECTIVE : The goal of this study was to compare the analgesic effect of sucrose with that of the combination of sucrose and the local anesthetic cream EMLA during venipuncture in preterm neonates . METHODS : This r and omized , double-blind prospect i ve study included infants younger than 37 weeks ' gestational age during 1 routine venipuncture for blood sampling . Each child r and omly received either sucrose plus application of a placebo cream ( S group ) or sucrose plus EMLA cream ( S+E group ) before venipuncture . Venipuncture-induced pain was assessed through videotapes of the procedures by using the Douleur Aiguë Nouveau-né ( DAN ) behavioral scale . Pain was assessed at 2 phases : during venipuncture ( from needle introduction to its removal ) and during the recovery period ( 30 seconds after needle removal ) . Pain scores over time and between treatments were compared by using repeated- measures analysis of variance . RESULTS : The study included 76 children ( 37 in the S group , 39 in the S+E group ) .  Mean ( SD ) DAN pain scores for the S group and the S+E group were 7.7 ( 2.1 ) and 6.4 ( 2.5 ) , respectively , during venipuncture and 7.1 ( 2.8 ) and 5.7 ( 3.3 ) during the postinjection period . A significant time and treatment effect in favor of the S+E group was observed . CONCLUSION : The combination of sucrose and EMLA cream revealed a higher analgesic effect than sucrose alone during venipuncture in these preterm infants OBJECTIVES Verbally administered numerical rating scales ( NRSs ) from 0 to 10 are often used to measure pain , but they have not been vali date d in the emergency department ( ED ) setting . The authors wished to assess the comparability of the NRS and  visual analog scale ( VAS )  as measures of acute pain , and to identify the minimum clinical ly significant difference in pain that could be detected on the NRS . METHODS This was a prospect i ve cohort study of a convenience sample of adults presenting with acute pain to an urban ED . Patients  verbally rated pain intensity as an integer from 0 to 10 ( 0 = no pain , 10 = worst possible pain ) , and marked a 10-cm horizontal VAS bounded by these descriptors .  VAS and NRS data were obtained at presentation , 30 minutes later , and 60 minutes later . At 30 and 60 minutes , patients were asked whether their pain was " much less , " " a little less , " " about the same , " " a little more , " or " much more . " Differences between consecutive pairs of measurements on the VAS and NRS obtained at 30-minute intervals were calculated for each of the five categories of pain descriptor . The association between VAS and NRS scores was expressed as a correlation coefficient . The VAS scores were regressed on the NRS scores in order to assess the equivalence of the measures . The mean changes associated with descriptors " a little less " or " a little more " were combined to define the minimum clinical ly significant difference in pain measured on the VAS and NRS . RESULTS Of 108 patients entered , 103 provided data at 30 minutes and 86 at 60 minutes . NRS scores were strongly correlated to VAS scores at all time periods ( r = 0.94 , 95 % CI = 0.93 to 0.95 ) . The slope of the regression line was 1.01 ( 95 % CI = 0.97 to 1.06 ) and the y-intercept was -0.34 ( 95 % CI = -0.67 to -0.01 ) . The minimum clinical ly significant difference in pain was 1.3 ( 95 % CI = 1.0 to 1.5 ) on the NRS and 1.4 ( 95 % CI = 1.1 to 1.7 ) on the VAS . CONCLUSIONS The findings suggest that the verbally administered NRS can be substituted for the VAS in acute pain measurement & NA ; Reliable and valid measures of pain are essential for conducting clinical trials of pain treatments . Perhaps the most important aspect of a pain measure 's validity is its sensitivity , or ability to detect changes in pain over time and due to treatment . Several factors may affect a measure 's sensitivity , including the complexity of the rating task for the measure , the number of pain intensity levels assessed by the measure , the dimension of pain assessed ( e.g. pain intensity vs. pain relief ) , and the number of individual ratings ( e.g. single rating vs. composite score ) used to create the measure . The purpose of this study was to compare the relative sensitivity of three measures of outcome and a composite made up of all three measures for detecting analgesic effects in two sample s of persons participating in a r and omized controlled trial . One hundred and twenty‐three patients who had undergone knee surgery and 124 women who had undergone a laparotomy were given one of three medications in the day after their surgery : morphine , ketorolac , or placebo . Two measures of pain intensity ( a visual analog scale ( VAS ) and a 4‐point verbal rating scale ( VRS ) ) were administered at baseline , and these measures plus a 5‐point VRS of pain relief were administered at 16 additional time points up to 24 h following surgery . As predicted , we found variability in the sensitivity of the outcome measures used in these studies , with the 4‐point VRS showing less sensitivity than the VAS or relief ratings . However , contrary to our prediction , a composite measure of outcome made up of all three measures was not consistently superior to the individual measures for detecting treatment effects . Finally , we found that pain relief ratings were related to , but also distinct from , change in pain intensity as measured by changes in pain intensity ratings from baseline to each postmedication assessment point . These findings have important implication s for the assessment of pain in clinical trials & NA ; Although the verbal numeric scale ( VNS ) is used frequently at patients ’ bedsides , it has never been formally vali date d in children with acute pain . In order to vali date this scale , a prospect i ve cohort study was performed in children between 8 and 17 years presenting to a pediatric emergency department ( ED ) with acute pain . Pain was grade d using the VNS , the visual analogue scale ( VAS ) , and the verbal rating scale ( VRS ) .  A second assessment was done before discharge . We determined a priori that in order to be valid , the VNS would need to : correlate with the VAS ( concurrent validity ) ; decrease after intervention to reduce pain ( construct validity ) ; and be associated with the VRS categories ( content validity ) . The VNS interchangeability with the VAS , its minimal clinical ly significant difference , and test – retest reliability were also determined . A total of 202 patients ( mean age : 12.2 ± 2.6 years ) were enrolled . The VNS correlated with the VAS : ric = 0.93 , p < 0.001 . There were differences in the VNS before versus after interventions ( p < 0.001 ) , and between VRS categories ( mild versus moderate , p < 0.001 ; moderate versus severe , p < 0.001 ) . The 95 % limits of agreement ( interchangeability ) between VNS/VAS were outside the a priori set limit of ±2.0 : −1.8 , 2.5 . The VNS minimal clinical ly significant difference was 1 . The VNS had good test – retest reliability with 95 % limits of agreement of −0.9 and 1.2 . In conclusion , the VNS  provides a valid and reliable scale to evaluate acute pain in children aged 8–17 years but is not interchangeable with the VAS OBJECTIVE To quantify , using two pain assessment scales , the amount of change in pain severity required to achieve a clinical ly significant improvement in pain in children presenting to a pediatric emergency department ( ED ) with pain . METHODS Prospect i ve , descriptive study involving all children presenting to a pediatric ED between 5 and 16 years of age inclusive with acute pain . Children were excluded if they 1 ) were intoxicated or had altered sensorium , 2 ) were clinical ly unstable , 3 ) were non-English-speaking , or 4 ) were developmentally delayed . Written informed consent was obtained . Children were asked to mark their current pain severity on the st and ardized Color Analogue Scale ( CAS ) and Faces Pain Scale ( FPS ) . After each pain control intervention the child was asked to repeat these measurements and to describe whether his or her pain was " much less , " " a little less , " " about the same , " " a little worse , " or " much worse " compared with before . This process was repeated until the child was discharged from the ED or had a score of zero . The main outcome measure was the smallest change on the CAS or FPS necessary to cause the child to describe his or her pain as a " little less . " This was defined as the clinical ly significant change in pain . The " ideal " change in pain was defined as the amount of change necessary for the child to describe the pain as " much less " or at which point the child thought he or she no longer required any medicine to help the pain go away . RESULTS One hundred twenty-one children were enrolled with a mean age of 9.8 years ( SD + /- 3.15 ) . Males accounted for 56 % . Pain was traumatic in 65 % and nontraumatic in 35 % . A total of 153 pain comparisons were made using the CAS and 154 using the FPS . Only three children complained that their pain got worse ( two a little worse and one much worse ) . Pain was described as " the same " in 20 . Of the 60 pain comparisons judged to be a " little less , " the CAS score changed by a median of 2.0 cm [ interquartile ratio ( IQR ) 1 - 3 ] , and the FPS by 1.0 face ( IQR 1 - 2 ) . In the 71 children who judged their pain to be " much less , " the CAS decreased by a median of 4.0 cm ( IQR 2 - 5 ) and the FPS by 2.0 faces ( IQR 2 - 3 ) . CONCLUSIONS The assessment and treatment of  pain in children are an important component of pediatric practice , especially in the ED . This study provides health care professionals and clinical investigators the information necessary to assess whether their method of pain control in children is clinical ly relevant BACKGROUND Vali date d health-related quality -of-life measures have become important st and ards in the evaluation of the outcomes of lumbar spine surgery . However , there are few well-defined criteria for clinical success based on these measures . The minimum clinical ly important difference is an important demarcation , but it could be considered a floor value rather than a goal in defining clinical success . Therefore , we sought to define thresholds of substantial clinical benefit for commonly used health-related quality -of-life measures following lumbar spine arthrodesis . METHODS Prospect ively collected preoperative and one-year postoperative health-related quality -of-life measures from 357 patients who were managed with lumbar spine arthrodesis for the treatment of degenerative conditions were identified . C and i date substantial clinical benefit thresholds for the Short Form-36 physical component score , Oswestry Disability Index , and back and leg pain numeric rating scales were identified with use of receiver operating characteristic curve analysis . Receiver operating characteristic curves were used to discriminate between patients who reported being " much better " or " about the same " with use of the vali date d Short Form-36 health transition item and between those who reported being " mostly satisfied " or " unsure " with use of a nonvali date d but more surgery-specific satisfaction-with- results survey . For each health-related quality -of-life measure , three response parameters were used : net change , percent change , and raw score at the time of the one-year follow-up . RESULTS Substantial clinical benefit thresholds for the Short Form-36 physical component score were a 6.2-point net improvement , a 19.4 % improvement , or a final raw score of > or = 35.1 points . Substantial clinical benefit thresholds for the Oswestry Disability Index were an 18.8-point net improvement , a 36.8 % improvement , or a final raw score of < 31.3 points . Substantial clinical benefit thresholds for the back pain and leg pain numeric rating scales were a 2.5-point net improvement or a final raw score of < 3.5 points . Substantial clinical benefit thresholds for percent change were 41.4 % for the back pain numeric rating scale and 38.8 % for the leg pain numeric rating scale . CONCLUSIONS We believe that thresholds of substantial clinical benefit for commonly used health-related quality -of-life measures following lumbar spine arthrodesis are important as they describe a magnitude of change that the patient recognizes as a major improvement STUDY OBJECTIVE We sought to determine the minimum clinical ly significant difference in visual analog scale ( VAS ) pain score for children . METHODS We performed a prospect i ve , single-group , repeated- measures study of children between 8 and 15 years presenting to an urban pediatric emergency department with acute pain . On presentation to the ED , patients marked the level of their pain on a 100-mm nonhatched VAS scale . At 20-minute intervals thereafter , they were asked to give a verbal categoric rating of their pain as " heaps better , " " a bit better , " " much the same , " " a bit worse , " or " heaps worse " and to mark the level of pain  on a VAS scale of the same type as used previously . A maximum of 3 comparisons was recorded for each child . The minimum clinical ly significant difference in VAS pain score was defined as the mean difference between current and preceding scores when the subject reported " a bit worse " or " a bit better " pain . RESULTS Seventy-three children were enrolled in the study , yielding 103 evaluable comparisons in which pain was rated as " a bit better " or " a bit worse . " The minimum clinical ly significant difference in VAS score was 10 mm ( 95 % confidence interval 7 to 12 mm ) . CONCLUSION This study found the minimum clinical ly significant difference in VAS pain score for children aged 8 to 15 years ( on a 100-mm VAS scale ) to be 10 mm ( 95 % confidence interval 7 to 12 mm ) . In studies of population s , differences of less than this amount , even if statistically significant , are unlikely to be of clinical significance BACKGROUND The patient acceptable symptom state ( PASS ) is the value beyond which patients can consider themselves well . This concept can help in interpreting results of clinical trials . OBJECTIVE To determine the PASS estimate for patients with knee and hip osteoarthritis ( OA ) by assessing pain , patient 's global assessment of disease activity , and functional impairment . METHODS A 4 week prospect i ve multicentre cohort study of 1362 out patients with knee or hip OA was carried out . Data on assessment of pain and patient 's global assessment of disease , measured on visual analogue scales , and functional impairment , measured on the Western Ontario McMaster Universities Osteoarthritis Index ( WOMAC ) function subscale , were collected at baseline and final visits . The patients assessed their satisfaction with their current state at the final visit . An anchoring method based on the patient 's opinion was used . RESULTS For patients with knee and hip OA , the estimates of PASS were , respectively , 32.3 and 35.0 mm for pain , 32.0 and 34.6 mm for patient global assessment of disease activity , and 31.0 and 34.4 points for WOMAC function score . The PASS varied moderately across the tertiles of baseline scores but not across age , disease duration , or sex . CONCLUSION The use of PASS in clinical trials would provide more meaningful results expressed as a proportion of patients in an acceptable symptom state OBJECTIVE To test whether a single-category improvement on a Likert pain relief scale equals the minimum clinical ly significant difference of 1.3 units in pain intensity reduction on a 10-unit numerical rating scale ( NRS ) . METHODS Prospect i ve cohort of adults with acute severe pain receiving st and ardized analgesia .  Patients rated pain intensity via NRS before receiving morphine and 30 minutes later . Patients described pain relief as " none , " " a little , " " moderate , " " a lot , " or " complete . " The primary outcome was the difference in NRS scores between each contiguous pair of pain relief categories over 30 minutes . RESULTS One hundred thirty-one patients , age range 21 to 65 years , median baseline NRS pain score 10 ( interquartile range , 9 - 10 ) . Patients whose relief was " complete , " " a lot , " " moderate , " " mild , " and " none " had the following NRS unit reductions in pain , respectively : 9 , 5.7 , 3.9 , 2.1 , and -0.1 . The difference between each pair of relief categories was 3.3 , 1.8 , 1.8 , and 2.2 units . CONCLUSION Each single-category improvement on a pain relief scale exceeds the minimum clinical ly significant difference in pain intensity as measured on an NRS OBJECTIVE Intravenous morphine has been used as a common method of pain control in emergency care . Nebulized fentanyl is also an effective temporary substitute . This study was design ed to compare the effectiveness of nebulized fentanyl with intravenous ( IV ) morphine on management of acute limb pain . METHODS This was a placebo-controlled , double-blind r and omized clinical trial . Ninety emergency department patients with moderate to severe pain aged 15 to 50 years were blocked r and omized and enrolled in this study . Forty-seven patients in the experimental group received nebulized fentanyl ( 4 μg/kg ) and IV normal saline as placebo , and the remaining 43 patients in the control group received IV morphine ( 0.1 mg/kg ) and nebulized normal saline as placebo . All participants ' pain scores were assessed by Numerical Rating Scale before and after intervention at 5- , 10- , 15- , 30- , 45- , and 60-minute intervals . Patients ' vital sign and possible adverse effects were recorded respectively . Finally , all participants were assessed for their satisfaction . RESULTS The mean initial pain score in the experimental group was 8.7 and 8.4 in the control group ( P = .1 ) . Pain relief in both groups after 5 and 10 minutes were similar ( P = .72 ) . Although the pain relief was significantly greater with fentanyl at 15 minutes , this difference is not clinical ly significant . Pain management in both groups was successful and was more than 3 scores reduction in Numerical Rating Scale . Patient satisfaction in both groups was similar . No adverse effects were reported in the experimental group . CONCLUSION This study suggests that nebulized fentanyl is a rapid , safe , and effective method for temporary control of acute limb pain in emergency department patients Abstract Objectives : To assess the level of pain intensity at which patients feel the impetus to ask for a breakthrough cancer pain ( BTcP ) medication , and level of pain intensity at which patients consider they have achieved acceptable pain control after receiving a BTcP medication . Methods : A consecutive sample of patients who were receiving oral morphine equivalents equal to or more than 60 mg daily , and were prescribed rapid onset opioids for the management of episodes of BTcP , were included in the study . Focused educational activities regarding BTcP and numerical scales were established during hospital admission . At discharge patients were interviewed to find out what was the pain intensity level which gave the impetus to take the BTcP medication , what was the pain intensity for acceptable pain control after a BTcP medication had been given , and which factors prevented the patient calling for BTcP medication . A brief COPE ( coping orientation to problems experienced ) question naire was also administered . Results : Fifty-two patients were recruited for this study . The meaningful pain intensity for asking for a BTcP medication was 7.1 ; 77 % of patients had a pain intensity of 7–8 on a numerical scale of 0–10 . The meaningful pain intensity for adequate analgesia after a BTcP medication was 3.5 . Similarly , 77 % of patients had a pain intensity of 3–4 . There was no relationship with the variables examined . Concerns by patients about the use of BTcP medications were minimal . Conclusion : The meaningful BTcP intensity and pain intensity expected after BTcP medication can be useful in selecting patients in studies of BTcP. The principal limitation of this study was the specific setting of an acute unit with specific features and the relatively low number of patients . This observation should be followed up by further surveys with a larger number of patients and different setting BACKGROUND AND METHODS From the time that Sinatra et al. ( Anesthesiology . 2005;102:822 ) was published to FDA apaproval of intravenous ( IV ) acetaminophen , an exp and ed analysis of the original raw study data became necessary for the regulatory su bmi ssion . The following analyses were conducted : ( 1 ) sum of pain intensity differences over 24 hours ( SPID24 ) using currently accepted imputation methods to account for both missing data and the effects of rescue ; ( 2 ) efficacy results after the first 6 hours ; ( 3 ) effects of gender , race/ethnicity , age , weight , surgical site , ASA Class , and serotonin antagonists ; and ( 4 ) a stepwise regression analysis of why adverse events of nausea and vomiting were numerically ( although not statistically ) higher in the IV acetaminophen group compared with placebo . RESULTS Sum of pain intensity differences over 24 hours using a 0- to 100-mm visual analog scale was statistically significantly ( P < 0.001 ) in favor of IV acetaminophen  ( n = 49 ) compared with placebo ( n = 52 ) . Time to rescue was found to be 3.9 and 2.1 hours , respectively , for total hip and knee arthroplasty compared with 0.8 hours for the placebo group . Rescue medication consumption , requests , and actual administration were all significantly lower in the IV acetaminophen group compared with placebo for each dosing interval , except in the 6- to 12-hours interval where a numerical trend was observed . Analysis of various subset variables demonstrated similar efficacy for each variable . A stepwise regression analysis demonstrated that AE reports of nausea and vomiting were most likely due to prer and omization events , particularly opioid consumption and presence of nausea prior to r and omization . CONCLUSION Repeated-dose 24-hours end points were found to be as robust as previously published results . IV acetaminophen  efficacy and safety appeared to be unaffected by specific subset variables . BACKGROUND For patients with surgical third molar removal , it is unknown what constitutes a clinical ly important change in patients ' visual analogue scale ( VAS ) reports of pain intensity . OBJECTIVES To determine what constitutes a clinical ly important change in pain intensity on a VAS following surgical removal of the third molar . METHODS The study population consisted of patients participating in three r and omized trials . Patients were asked to rate their pain three times per day over a period of seven days on a 100 mm VAS after surgical removal of the third molar . Global Perceived Effect was measured on day 1 and day 7 and was used as the external criterion for assessing clinical ly important pain reduction . Global Perceived Effect scores of 6 ( ' much improved ' ) or higher were classified as clinical ly ' successful ' , and scores of 5 ( ' slightly improved ' ) or below were classified as clinical ly ' unsuccessful ' . For each trial , the mean absolute and relative changes in VAS scores were calculated for both ' successful ' and ' unsuccessful ' treatments . Sensitivity and specificity analyses were performed . RESULTS The patients who reported ' successful ' pain reduction showed a relative pain reduction of ≥69 % and an absolute pain reduction > 2.5 cm on the VAS , whereas patients who classified their pain reduction as ' unsuccessful ' had a relative pain reduction of ≤18.5 % and an absolute pain reduction < 0.5 cm on the VAS . Furthermore , sensitivity and specificity analyses showed that a cut-off point of ≥50 % relative pain reduction exhibited the best balance of sensitivity and specificity . CONCLUSION Relative pain reduction of ≥50 % and an absolute pain reduction of ≥2.5 cm on the VAS were most accurate in predicting a successful pain reduction after a given treatment OBJECTIVE To determine the most appropriate means to assess the response to treatment in terms of  pain and functional impairment in a chronic rheumatic condition ( knee osteoarthritis [ OA ] ) and an acute rheumatic condition ( rotator cuff syndrome [ RCS ] ) . METHODS Two prospect i ve studies were conducted consisting of 1,019 out patients with knee OA and 271 patients with acute RCS . The minimal clinical ly important improvement and the patient acceptable symptom state were determined for knee OA pain using a visual analog scale , and for knee OA function using the Western Ontario and McMaster Universities Osteoarthritis Index function subscale ; for acute RCS pain , a numeral rating scale was used , and the Neer function subscale was used for RCS function . RESULTS The minimal clinical ly important improvement was shown to be the change required to achieve the patient acceptable symptom state , whatever the baseline level of symptom , the outcome ( pain or function ) , or type of condition ( chronic or acute ) . This acceptable state for pain was higher for chronic ( 27.0 - 36.4 across the baseline score ) than acute ( 16.7 - 24.1 ) conditions . The level of functional impairment considered satisfactory by patients with knee OA was higher for more disabled patients ( 43.1 ) than for less disabled patients ( 20.4 ) . CONCLUSION Patients consider that they experienced an important improvement only if this improvement allowed them to achieve a state they consider satisfactory . The most appropriate means to assess the response to therapy seems to be to assess whether patients feel good ( i.e. , achieve the patient acceptable symptom state ) PURPOSE To determine whether adding regular acetaminophen ( paracetamol ) could improve pain and well-being in people with advanced cancer and pain despite strong opioids . PATIENTS AND METHODS Participants took acetaminophen for 48 hours and placebo for 48 hours . The order ( acetaminophen or placebo first ) was r and omly allocated . Pain was the primary outcome . Preferences , number of opioid breakthrough doses , overall well-being , nausea and vomiting , drowsiness , constipation , and cold sweats were secondary outcomes . Patients rated themselves daily with visual analog scales ( VAS ) and a verbal numeric scale ( VNS ) for pain , all scaled from 0 to 10 . RESULTS Thirty patients completed the trial . The oral opioid was morphine in 23 patients and hydromorphone in seven patients . The median daily opioid dose in oral morphine equivalents was 200 mg ( range , 20 to 2,100 mg ) . Nonsteroidal anti-inflammatory drugs , corticosteroids , or both were used by 16 patients . Pain and overall well-being were better for patients receiving acetaminophen than for those receiving placebo . The mean difference was 0.4 ( 95 % CI , 0.1 to 0.8 ; P = .03 ) in VNS for pain , 0.6 ( 95 % CI , -0.1 to 1.3 ; P = .09 ) in VAS for pain , and 0.7 ( 95 % CI , 0.0 to 1.4 ; P = .05 ) in VAS for overall well-being . More patients preferred the period they took acetaminophen ( n = 14 ) than the period they took placebo ( n = 8) , but many had no preference ( n = 8) . There were no differences in the other outcomes . CONCLUSION Acetaminophen improved pain and well-being without major side effects in patients with cancer and persistent pain despite a strong opioid regimen . Its addition is worth considering in all such patients BACKGROUND CONTEXT Various method ologies have been used in attempting to eluci date a st and ard method for calculating minimal clinical ly important difference ( MCID ) . A consensus-based decision ( Initiative on Methods , Measurement , and Pain Assessment in Clinical Trials [ IMMPACT ] group ) suggested a 30 % reduction from baseline as a means to define the MCID of self-report back pain measures . Additionally , important psychometric issues need to be addressed regarding use of an independent measure of the same construct as an external criterion , instead of simply using another self-report measure , when using an anchor-based approach to MCID . PURPOSE The purpose was to test the validity of recently published guidelines regarding MCID using self-report back pain measures and objective socioeconomic outcomes . STUDY DESIGN / SETTING This is a prospect i ve study assessing change scores on commonly used spinal pain assessment measures in patients with chronic disabling occupational spinal disorders ( CDOSDs ) treated in a regional referral rehabilitation center performing interdisciplinary functional restoration . PATIENT SAMPLE The study consisted of consecutive cohort of patients ( N=1,180 ) with CDOSDs completing a functional restoration program . OUTCOMES MEASURES Self-report measures including the Oswestry Disability Index ( ODI ) and the physical component summary ( PCS ) and mental component summary ( MCS ) of the Short Form-36 ( SF-36 ) obtained before and after treatment , were compared with objective socioeconomically relevant outcomes obtained 1 year after treatment ( ie , work status and additional health-care utilization ) , that were the external criteria for evaluating MCID . METHODS Pre- to posttreatment improvement was calculated separately for each measure , and subjects were divided into two groups based on the change in scores relative to baseline : 30 % or greater versus less than 30 % improvement . One-year posttreatment objective socioeconomic outcomes were used as independent external criteria relevant to the CDOSD population . This population is often studied as the most costly and problematic cohort in spine care . RESULTS The ODI and SF-36 MCS were not associated with any of the objective 1-year outcomes used as external criteria . Reduced post-rehabilitation health-care utilization ( based on the percentage of patients pursuing health care from a new provider ) was weakly associated with 30 % or greater improvement on the SF-36 PCS , relative to patients whose scores changed by less than 30 % relative to baseline ( 17.0 % vs. 21.1 % ) . The same was true for the ODI and return-to-work . CONCLUSIONS When objective and independent criteria are used ( socioeconomic outcomes ) in a CDOSD cohort , the 30 % improvement in the ODI and SF-36 may not be a valid MCID index . This replicates similar conclusions made by an independent research group using a distribution-based approach to MCID . The validity of the MCID concept rests on future research using objective external criteria . Moreover , there remains a question whether the term " important " in MCID can be unequivocally and operationally defined as a reliable construct OBJECTIVE To correlate measured  pain intensity ( PI  ) changes with pain relief and satisfaction with pain management . METHODS A prospect i ve single-group repeated- measures design study . A heterogeneous group of patients were asked to record their levels of PI at initial presentation and at ED release using a numerical  descriptor  scale ( NDS ) and a visual analog scale ( VAS ) . At release , a  5-point pain relief scale  and a  pain management satisfaction survey  were also completed . RESULTS A convenience sample of 81 patients were enrolled over the study period . The average reduction in PI for all patients was 33 % . A 5 % , 30 % , and 57 % reduction in PI correlated with " no , " " some/partial , " and " significant/complete " relief , respectively ( p < 0.001 ) . However , when patients were divided into 2 groups based on their initial PI scores , patients with moderate/severe pain ( NDS > 5 ) required a reduction of 35 % and 84 % in PI to achieve " some/partial " and " significant/complete " relief , respectively . Patients in less pain ( NDS < or = 5 ) needed 25 % and 29 % reductions in PI for the same categories ( p=0.8 ) . Patients were generally satisfied with their pain management . There was a positive association between pain relief and satisfaction with pain management . CONCLUSION There is a significant association between changes in PI and pain relief . Greater reductions in PI are required for patients presenting with more severe initial pain to achieve relief compared with those who have lesser initial PI . While there is a linear relationship between increasing pain relief and satisfaction , relief of pain appears to only partially contribute to overall satisfaction with pain management Aim : To quantify and compare the responsiveness within the meaning of clinical relevance of efficacy endpoints in a clinical trial with over the counter ( OTC ) analgesics for headache . Efficacy endpoints and observed differences in clinical trials need to be clinical ly meaningful and mirror the change in the clinical status of a patient . This must be demonstrated for the specific disease indication and the particular patient population based on the application of treatments with proven efficacy . Methods : Patient ’s global efficacy assessment during two study phases ( pre-phase and treatment phase ) was used to classify patients as satisfied or non-satisfied with the efficacy of their medication . The analysis is based on 1734 patients included in the efficacy analysis of a r and omized , placebo-controlled , double-blind , multi-centre parallel group trial with six treatment arms . Based on this classification and the pain intensity recorded by the patients on a 100 mm visual analogue scale , group differences by assessment categories and receiver operating characteristic ( ROC ) curve methods were used to quantify responsiveness of the efficacy endpoints ‘ time to 50 % pain relief ’ , ‘ time until reduction of pain intensity to 10 mm ’ , ‘ weighted sum of pain intensity difference ’ ( % SPIDweighted ) , ‘ pain intensity difference ( PID ) relative to baseline at 2 hours ’ , and ‘ pain-free at 2 hours ’ . Results : Clinical ly relevant differences between patients satisfied and non-satisfied with the treatment were observed for all efficacy endpoints . Patients with the highest rating of efficacy had the fastest and strongest pain relief . In comparison , patients assessing efficacy as ‘ less good ’ reached a 50 % pain relief on average nearly an hour later than those scoring efficacy as at least ‘ good ’ . Simultaneously , their extent of pain relief was only half as great 2 hours after medication intake . Patients scoring efficacy as ‘ poor ’ experienced practically no pain relief within the 4 hour observation interval . ROC curve calculations confirmed an adequate responsiveness for all continuous endpoints . The following cut-off points for differentiating between satisfied and non-satisfied patients were deduced from the data in the pre- and treatment phase , respectively : ‘ time to 50 % pain relief ’ 1:10 and 1:31 h : min , ‘ time until reduction of pain intensity to 10 mm ’ 2:40 and 3:00 h : min , ‘ % SPIDweighted ’ 68 and 64 % , ‘ PID at 2 hours ’ 35 and 35 mm . The sensitivity and specificity based on these cut-off points ranged from 70 to 79 % . The binary endpoint ‘ pain-free at 2 hours ’ showed a clearly higher specificity ( 80 and 87 % ) than sensitivity ( 65 and 61 % ) in the pre- and treatment phase , respectively . Conclusions : When global assessment of efficacy by the patient was used as external criterion , ROC curve calculations confirmed a high responsiveness for all efficacy endpoints included in this study . Clinical ly relevant differences between patients satisfied and non-satisfied with the treatment were observed . The endpoint ‘ % SPIDweighted ’ proved slightly but consistently superior to the other endpoints . SPID and % SPIDweighted are not easy to interpret and the time course of pain reduction is of high importance for the patients in the treatment of acute pain , including headache . The endpoint ‘ pain-free at 2 hours ’ showed the expected high specificity , but at the cost of a concurrently low sensitivity and clearly makes less use of the available information than the endpoint ‘ time to 50 % pain reduction ’ , which combines the highly relevant aspects of time course and extent of pain reduction . Responsiveness , the ability of an outcome measure to detect clinical ly important changes in a specific condition of a patient , should be added in future revisions of IHS guidelines for clinical trials in headache disorders The objective of the study was to assess the validity and reliability of the  visual analog scale ( VAS )  in the measurement of acute abdominal pain , and to identify the minimum clinical ly significant difference in VAS scores among patients with acute abdominal pain . The study was undertaken in preparation for a r and omized clinical trial of opioid use in acute abdominal pain . A prospect i ve , observational cohort study of a convenience sample of patients presenting to 2 urban EDs with the chief complaint of acute abdominal pain was conducted . At time 0 and 1 minute later each subject indicated pain severity on a 100 mm VAS . This was repeated every 30 minutes for 2 hours . Patients were also asked to contrast their current pain severity with their pain in the preceding 30 minutes using one of 5 grade d verbal descriptors : " much less pain , " " little less pain , " " the same pain , " " little more pain , " and " much more pain . " Validity was assessed by performing an analysis of variance for linear trend on the association between the 5 categorical pain descriptors and change in VAS scores . Reliability was assessed using the intra-class correlation coefficient ( ICC ) between VAS scores taken 1 minute apart , supplemented by a Bl and -Altman analysis . The minimum clinical ly significant difference in pain was defined as the mean difference between sequential VAS scores obtained 30 minutes apart when the patient noted a " little less " or " little more " pain . Differences in VAS scores increased linearly as pain descriptors escalated from " much less " to " much more " pain ( P < .001 ) . Reliability was high , ICC = 0.99 [ 95%CI 0.989 to 0.992 ] for 0 and 1 minute VAS scores . The minimum clinical ly significant difference in acute abdominal pain was 16 mm ( 95 % CI 13 , 18 mm ) . VAS measures of acute abdominal pain are valid and reliable . The 95 % CI surrounding the minimum clinical ly significant difference of approximately 16 mm overlaps with the 95 % CI of minimum clinical ly significant difference of approximately 13 mm reported previously in traumatic and other types of acute pain . We conclude that the VAS is a method ologically sound instrument for quantitative assessment of acute abdominal pain and for detecting clinical ly important changes in such pain 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 IMPORTANCE Low back pain ( LBP ) is responsible for more than 2.5 million visits to US emergency departments ( EDs ) annually . These patients are usually treated with nonsteroidal anti-inflammatory drugs , acetaminophen , opioids , or skeletal muscle relaxants , often in combination . OBJECTIVE To compare functional outcomes and pain at 1 week and 3 months after an ED visit for acute LBP among patients r and omized to a 10-day course of ( 1 ) naproxen + placebo ; ( 2 ) naproxen + cyclobenzaprine ; or ( 3 ) naproxen + oxycodone/acetaminophen . DESIGN , SETTING , AND PARTICIPANTS This r and omized , double-blind , 3-group study was conducted at one urban ED in the Bronx , New York City . Patients who presented with nontraumatic , nonradicular LBP of 2 weeks ' duration or less were eligible for enrollment upon ED discharge if they had a score greater than 5 on the Rol and -Morris Disability Question naire ( RMDQ ) .  The RMDQ is a 24-item question naire commonly used to measure LBP and related functional impairment on which 0 indicates no functional impairment and 24 indicates maximum impairment . Beginning in April 2012 , a total of 2588 patients were approached for enrollment . Of the 323 deemed eligible for participation , 107 were r and omized to receive placebo and 108 each to cyclobenzaprine and to oxycodone/acetaminophen . Follow-up was completed in December 2014 . INTERVENTIONS All participants were given 20 tablets of naproxen , 500 mg , to be taken twice a day . They were r and omized to receive either 60 tablets of placebo ; cyclobenzaprine , 5 mg ; or oxycodone , 5 mg/acetaminophen , 325 mg . Participants were instructed to take 1 or 2 of these tablets every 8 hours , as needed for LBP . They also received a st and ardized 10-minute LBP educational session prior to discharge . MAIN OUTCOMES AND MEASURES The primary outcome was improvement in RMDQ between ED discharge and 1 week later . RESULTS Demographic characteristics were comparable among the 3 groups . At baseline , median RMDQ score in the placebo group was 20 ( interquartile range [IQR],17 - 21 ) , in the cyclobenzaprine group 19 ( IQR,17 - 21 ) , and in the oxycodone/acetaminophen group 20 ( IQR,17 - 22 ) . At 1-week follow-up , the mean RMDQ improvement was 9.8 in the placebo group , 10.1 in the cyclobenzaprine group , and 11.1 in the oxycodone/acetaminophen group . Between-group difference in mean RMDQ improvement for cyclobenzaprine vs placebo was 0.3 ( 98.3 % CI , -2.6 to 3.2 ; P = .77 ) , for oxycodone/acetaminophen vs placebo , 1.3 ( 98.3 % CI , -1.5 to 4.1 ; P = .28 ) , and for oxycodone/acetaminophen vs cyclobenzaprine , 0.9 ( 98.3 % CI , -2.1 to 3.9 ; P = .45 ) . CONCLUSIONS AND RELEVANCE Among patients with acute , nontraumatic , nonradicular LBP presenting to the ED , adding cyclobenzaprine or oxycodone/acetaminophen to naproxen alone did not improve functional outcomes or pain at 1-week follow-up . These findings do not support use of these additional medications in this setting . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01587274 OBJECTIVES /HYPOTHESIS Sore throat is a common , benign emergency department ( ED ) presentation ; however , peritonsillar abscess ( PTA ) is a complication that requires aggressive management . Use of systemic corticosteroids ( SCSs ) in PTA is occurring without clear evidence of benefit . This study examined the efficacy and safety of SCS treatment for patients with PTA . STUDY DESIGN R and omized , double-blind , placebo-controlled trial . METHODS A controlled trial with concealed allocation and double-blinding was conducted at two Canadian EDs . Following written informed consent , eligible patients received 48 hours of intravenous clindamycin and a single dose of the study drug ( dexamethasone [ DEX ] or placebo [ PLAC ] , intravenously [ IV ] ) . Follow-up occurred at 24 hours , 48 hours , and 7 days . The primary outcome was pain ; other outcomes were side effects and return to normal activities/diet . RESULTS A total of 182 patients were screened for eligibility ; 41 patients were enrolled ( 21 DEX ; 20 PLAC ) . At 24 hours , those receiving DEX reported lower pain scores ( 1.4 vs. 5.1 ; P = .009 ) ; however , these differences disappeared by 48 hours ( P = .22 ) and 7 days ( P = .4 ) . At 24 hours , more patients receiving DEX  returned to normal activities ( 33 % vs. 11 % ) and dietary intake ( 38 % vs 25 % ) ; however , these differences were not significant and disappeared by 48 hours and 7 days . Side effects were rare and did not differ between groups ( P > .05 ) . CONCLUSIONS Combined with PTA drainage and IV antibiotics , 10 mg IV DEX result ed in less pain at 24 hours when compared to PLAC , without any serious side effects . This effect is short-lived , and further research is required on factors associated with PTA treatment success
target: 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: 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 .