title: Epidemiology of chronic non-malignant pain in Denmark Increasing value and reducing waste in research design, conduct, and analysis Do psychological factors predict outcome in both low-back pain and shoulder pain? Independent evaluation of a clinical prediction rule for spinal manipulative therapy: a randomised controlled trial Point-of-care prognosis for common musculoskeletal pain in older adults. Are prognostic indicators for poor outcome different for acute and chronic low back pain consulters in primary care? Does a patient’s physical activity predict recovery from an episode of acute low back pain? A prospective cohort study Psychosocial Variables in Patients With (Sub)Acute Low Back Pain: An Inception Cohort in Primary Care Physical Therapy in the Netherlands A longitudinal study on the predictive validity of the fear–avoidance model in low back pain Fear of Movement/(Re)Injury Predicting Chronic Disabling Low Back Pain: A Prospective Inception Cohort Study Clinical course and prognostic factors in acute neck pain: an inception cohort study in general practice. A randomized controlled trial comparing manipulation with mobilization for recent onset neck pain. People seeking treatment for a new episode of neck pain typically have rapid improvement in symptoms: an observational study. The role of fear-avoidance beliefs in acute low back pain: relationships with current and future disability and work status Prognostic occupational factors for persistent low back pain in primary care The Natural History of Headache: Predictors of Onset and Recovery Predictors of return to work in patients sick listed for sub-acute low back pain: a 12-month follow-up study. Outcome Determinants of Subacute Low Back Pain A Clinical Prediction Rule To Identify Patients with Low Back Pain Most Likely To Benefit from Spinal Manipulation: A Validation Study Screening to Identify Patients at Risk: Profiles of Psychological Risk Factors for Early Intervention
abstract: & NA ; A series of health surveys are conducted every sixth to seventh year in Denmark . In the most recent survey of 2000 , a national r and om sample ( > 16 years ) was drawn from the Danish Central Personal Register . Out of the original sample 12,333 ( 74 % ) were interviewed and of these 10,066 returned a completed question naire ( SF‐36 ) . The present study includes only those who both took part in the interview and the postal question naire . Cancer patients were excluded . Persons suffering from chronic pain ( PG ) were identified through the question ‘ Do you have chronic/long lasting pain lasting 6 months or more ’ ? An overall chronic pain prevalence of 19 % was found −16 % for men and 21 % for women . Prevalence of chronic pain increased with increasing age . Persons ≥67 years had 3.9 higher odds of suffering from chronic pain than persons in the age group 16–24 years . Compared with married persons , divorced or separated persons had 1.5 higher odds of chronic pain . Odds for chronic pain were 1.9 higher among those with an education of less than 10 years compared with individuals with an education of 13 years or more . During a 14‐day period reporters of chronic pain had an average of 0.8 days ( range 0–10 ) lost due to illness compared with an average of 0.4 days ( range 0–10 ) for the control group ( CG ) ( Odds Ratio ( OR ) ) 2.0 ) . Persons with a job which required high physical strain were more likely to report chronic pain compared with those with a sedentary job ( OR 2.2 ) . The odds of quitting one 's job because of ill health were seven times higher among people belonging to the PG . A strong association between chronic pain and poor self‐rated health was also demonstrated . The PG had twice as many contacts with various health professionals compared with the CG , and the health care system was , on average , utilised 25 % more ( overall contacts ) by the PG than by the general population . Among the persons in the PG , 33 % were not satisfied with the examinations carried out in connection with their pain condition and 40 % were not satisfied with the treatment offered . Nearly 130,000 adults , corresponding to 3 % of the Danish population , use opioids on a regular basis . Opioids are used by 12 % of the PG Correctable weaknesses in the design , conduct , and analysis of biomedical and public health research studies can produce misleading results and waste valuable re sources . Small effects can be difficult to distinguish from bias introduced by study design and analyses . An absence of detailed written protocol s and poor documentation of research is common . Information obtained might not be useful or important , and statistical precision or power is often too low or used in a misleading way . Insufficient consideration might be given to both previous and continuing studies . Arbitrary choice of analyses and an overemphasis on r and om extremes might affect the reported findings . Several problems relate to the research workforce , including failure to involve experienced statisticians and method ologists , failure to train clinical research ers and laboratory scientists in research methods and design , and the involvement of stakeholders with conflicts of interest . Inadequate emphasis is placed on recording of research decisions and on reproducibility of research . Finally , reward systems incentivise quantity more than quality , and novelty more than reliability . We propose potential solutions for these problems , including improvements in protocol s and documentation , consideration of evidence from studies in progress , st and ardisation of research efforts , optimisation and training of an experienced and non-conflicted scientific workforce , and reconsideration of scientific reward systems Background and Objective : Psychological factors are assumed to predict persistent or recurrent musculoskeletal pain . The influence of psychological factors in patients with low-back pain ( LBP ) or shoulder pain was explored to study whether there is similarity regarding the factors that predict persisting pain and disability . Methods : Patients presenting in primary care with a new episode of shoulder pain or non-specific (sub)acute low back pain ( LBP ) were enrolled in a prospect i ve study . In both patient groups ,  pain catastrophising , distress , somatisation and fear-avoidance beliefs  were measured at baseline . Primary outcome measures at 3 months were ( 1 ) persistent symptoms , and ( 2 ) < 30 % reduction in functional disability .  Multivariate logistic regression analysis was used to study the associations between psychological factors and outcome . Results : A total of 587 patients with shoulder pain and 171 patients with LBP were enrolled in the study . In patients with shoulder pain , most associations of psychological factors with outcome were weak and not significant . Only in patients with longer symptom duration at baseline ( ⩾3 months ) were higher scores on catastrophising significantly associated with persistent symptoms ( p = 0.04 ) . In patients with LBP , psychological factors were more strongly associated with poor outcome , although most associations were not significant . Conclusion : Psychological factors , with the exception of fear-avoidance beliefs , are more strongly associated with persistent pain and disability in patients with LBP than in those with shoulder pain . This seems to indicate that in a primary care population the influence of psychological factors on outcome may vary across patients with different types of pain A clinical prediction rule to identify patients most likely to respond to spinal manipulation  has been published and widely cited but requires further testing for external validity . We performed a pre-planned secondary analysis of a r and omised controlled trial investigating the efficacy of spinal manipulative therapy in 239 patients presenting to general practice clinics for acute , non-specific , low back pain . Patients were r and omised to receive spinal manipulative therapy or placebo 2 to 3 times per week for up to 4 weeks . All patients received general practitioner care ( advice and paracetamol ) . Outcomes were pain and disability measured at 1 , 2 , 4 and 12 weeks . Status on the clinical prediction rule was measured at baseline . The clinical prediction rule performed no better than chance in identifying patients with acute , non-specific low back pain most likely to respond to spinal manipulative therapy  ( pain P = 0.805 , disability P = 0.600 ) . At 1-week follow-up , the mean difference in effect of spinal manipulative therapy  compared to placebo in patients who were rule positive rather than rule negative was 0.3 points less on a 10-point pain scale ( 95 % CI −0.8 to 1.4 ) . The clinical prediction rule proposed by Childs et al. did not generalise to patients presenting to primary care with acute low back pain who received a course of spinal manipulative therapy IMPORTANCE Many site-specific , multivariable risk models for predicting the outcome of musculoskeletal pain problems have been published . The overlapping content in these models suggests a common set of generic indicators suitable for use in primary care . OBJECTIVE To investigate whether a brief set of generic prognostic indicators can predict the outcome of musculoskeletal pain in older patients presenting to general practitioners . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve observational cohort study conducted from September 1 , 2006 , through March 31 , 2007 , of consecutive patients 50 years or older presenting with noninflammatory musculoskeletal pain to 1 of the 5 participating general practice s in the United Kingdom . MAIN OUTCOME MEASURES During consultation , the treating physician assessed and recorded 5 brief generic items ( duration of present pain episode , current pain intensity , pain interference with daily activities , presence of multiple-site pain , and ultrashort depression screen ) and recorded their overall prognostic judgment . The primary outcome was patient-rated improvement , which was measured 6 months after consultation and cross-vali date d with repeated measures up to 3 years . RESULTS A total of 194 ( 48.1 % ) of 403 participants were classified as having an unfavorable outcome at 6 months . Inclusion of 3 generic prognostic indicators ( duration of present pain episode , pain interference with daily activities , and presence of multiple-site pain ) in the prognostic model improved on reliance on physicians ' prognostic judgment alone ( C statistic = 0.72 vs 0.62 ; net reclassification index = 0.136 ; proportion correctly classified = 69 % ) . The improvement in prognostic accuracy was attributable to correcting physicians ' tendency toward overoptimistic expectations of outcome . CONCLUSIONS AND RELEVANCE Three easy-to-obtain pieces of information followed by systematic recording of the general practitioners ' prognostic judgment provide a simple generic assessment of prognosis at point of care in older persons presenting with musculoskeletal problems to primary care practice s in the United Kingdom . Such an assessment offers a common foundation for investigating the usefulness of prognostic stratification for guiding management in the consultation across a range of common painful conditions & NA ; Few studies have investigated whether prognostic indicators , which contribute to the transition from acute to chronic low back pain ( LBP ) , are also those which contribute to continuing persistence of chronic LBP . We compared the contribution of physical , psychological and social indicators to predicting disability after one year between consulters with LBP of less than 3 months duration and more than 3 months duration . Data from two large prospect i ve cohort studies of consecutive patients consulting with LBP in general practice s were merged , providing complete data for 258 cases with acute/subacute LBP and 668 cases with chronic LBP at 12 months follow‐up . There were significant differences between the two LBP groups in baseline characteristics and clinical course of disability , assessed by Rol and Morris Disability Question naire , during the year of follow‐up . Adjusted associations between potential prognostic indicators and disability at 12 months were carried out in the two LBP subgroups . The final multivariable regression models showed that being non‐employed , having widespread pain , a high level of Chronic Pain Grade , and catastrophising were the strongest prognostic indicators for disability at 12 months in both LBP groups . Fear of pain was significantly associated with disability in chronic LBP . Importantly , beyond baseline disability , the effect size of the other prognostic indicators for poor outcome was rather low . These findings must continue to challenge research ers to identify useful early predictors of outcome in persons with disabling back pain , as screening and targeted treatment approaches are dependent upon prognostic indicators with clinical significance Background Advice to remain active and normalisation of activity are commonly prescribed in the management of low back pain ( LBP ) . However , no research has assessed whether objective measurements of physical activity predict outcome and recovery in acute low back pain . Method The aims of this study were to assess the predictive relationship between activity and disability at 3 months in a sub-acute LBP population . This prospect i ve cohort study recruited 101 consenting patients with sub-acute LBP ( < 6 weeks ) who completed the Rol and Morris Disability Question naire ( RMDQ ) , the Visual Analogue Scale , and resumption of full ‘ normal ’ activity question ( Y/N ) , at baseline and 3 months .  Physical activity  was measured for 7 days at both baseline and at 3 months with an RT3 accelerometer and a recall question naire . Results Observed and self-reported measures of physical activity at baseline and change in activity from baseline to 3 months were not independent predictors of RMDQ ( p > 0.05 ) or RMDQ change ( p > 0.05 ) over 3 months . A self-report of a return to full ‘ normal ’ activities was significantly associated with greater RMDQ change score at 3 months ( p < 0.001 ) . Paired t-tests found no significant change in activity levels measured with the RT3 ( p = 0.57 ) or the recall question naire ( p = 0.38 ) from baseline to 3 months . Conclusions These results question the predictive role of physical activity in LBP recovery , and the assumption that activity levels change as LBP symptoms resolve . The importance of a patient ’s perception of activity limitation in recovery from acute LBP was also highlighted . Trial registration Clinical Trial Registration Number , Study Design . A prospect i ve cohort study of patients with episodes of acute or subacute low back pain , seeking physical therapy in primary care , with follow-up at weeks 2 , 4 , 8 , and 12 . Objectives . To evaluate the association between psychosocial factors and the transition from acute or subacute low back pain to chronicity . Summary of Background Data . Psychosocial factors have long been thought to be associated with chronic pain only . Recent prospect i ve studies , however , suggest that these factors may also be important in acute or subacute low back pain . Methods . Demographic , psychosocial , and psychological baseline data were collected and analyzed from a sample of 66 acute or subacute patients with low back pain in order to predict the 3-month outcome . Results . After 3 months , response rate was 85 % ( 56 patients ) . Forty-five percent rated their current status as “ not recovered . ” Twelve percent reported work absenteeism . Using multiple regression analyses , baseline scores on the  Acute Low Back Pain Screening Question naire , Pain Coping Inventory , Fear-Avoidance Beliefs Question naire , and Tampa Scale for Kinesiophobia were not significantly associated with nonrecovery at 3 months . The only significant predictor at baseline was the subscale pain of the ALBPSQ , correctly classifying 80 % of the patients . The relative risk for not being recovered was 3.72 ( 95 % confidence interval , 1.63–8.52 ) for the subjects with high scores on the subscale for pain . Pain scores and scores on psychosocial variables at 12 weeks were not associated . Conclusions . The study strongly revealed pain-related items to be essential factors in the development of chronicity and long-term disability in primary care physical therapy . Health status at 8 weeks seems crucial in developing chronicity & NA ; Recently , fear – avoidance models have been quite influential in underst and ing the transition from acute to chronic low back pain ( LBP ) . Not only has pain‐related fear been found to be associated with disability and increased pain severity , but also treatment focused at reducing pain‐related fear has shown to successfully reduce disability levels . In spite of these developments , there is still a lack in well‐ design ed prospect i ve studies examining the role of pain‐related fear in acute back pain . The aim of the current study was to prospect ively test the assumption that pain‐related fear in acute stages successfully predicts future disability .  Subjects were primary care acute LBP patients consulting because of a new episode of LBP ( ≤3 weeks ) . They completed question naires on background variables , fear – avoidance model variables and LBP outcome ( Grade d Chronic Pain Scale , GCPS ) at baseline , 3 , 6 , and 12 months follow‐up and at the end of the study . Two‐hundred and twenty‐two acute LBP patients were included , of whom 174 provided full follow‐up information ( 78.4 % ) . A backward ordinal regression analysis showed previous LBP history and pain intensity to be the most important predictors of end of study GCPS . Of the  fear – avoidance model  variables , only negative affect added to this model . Our results do not really support the longitudinal validity of the fear – avoidance model , but they do feed the discussion on the role of pain‐related fear in early stages of LBP Study Design . Prospect i ve inception cohort study . Objective . To investigate prospect ively whether pain-related fear predicts future perceived disability and participation in patients with acute low back pain ( LBP ) . Summary of Background Data . There are indications that fear of movement/(re)injury , as measured by the Tampa Scale for Kinesiophobia , is present early in an episode of LBP , and that it might be a predictor of future perceived disability and participation . Methods . A cohort of 555 patients with acute LBP included by general practitioners and physical therapists in primary care setting s was followed for 6 months . Results . Results indicate that baseline fear of movement/(re)injury was predictive of future perceived disability and , to a lesser extent ( and together with duration and radiation ) , of participation . Conclusions . The results suggest that interventions aim ed at reducing pain-related fear in the acute stage of LBP might prevent restrictions of activity and participation because of pain , and might be a way of preventing the transition from acute to chronic LBP OBJECTIVE To describe the natural course of patients with acute neck pain presenting in general practice and to identify prognostic factors for recovery and sick leave . DESIGN We conducted a prospect i ve cohort study with a 1-year follow-up in general practice . Question naires were collected at baseline and after 6 , 12 , 26 , and 52 weeks . Days of sick leave were dichotomized into two groups : below and above 7 days of sick leave . Logistic regression was used to identify prognostic factors for recovery and sick leave . PATIENTS Consecutive patients with nonspecific neck pain lasting no longer than 6 weeks were invited to participate . RESULTS One hundred eighty-seven patients were included and 138 ( 74 % ) provided follow-up data . After 1 year , 76 % of the patients stated to be fully recovered or much improved , although 47 % reported to have ongoing neck pain . Almost half of the patients on sick leave at baseline returned to work within 7 days . Multivariate analysis showed that the highest association with recovery was the advice of the general practitioner ( GP ) " to wait and see " ( odds ratio [ OR ] 6.7 , 95 % confidence interval [ CI ] 1.6 - 31.8 ) . For sick leave , referral by the GP , for physical therapy or to a medical specialist , showed the highest association ( OR 2.8 , 95 % CI 1.0 - 8.4 ) . CONCLUSION Acute neck pain had a good prognosis for the majority of patients , but still a relatively high proportion of patients reported neck pain after 1-year follow-up . The advice given by the GP " to wait and see " was associated with recovery , and " referral " was associated with prolonged sick leave UNLABELLED A r and omized controlled trial comparing manipulation with mobilization for recent onset neck pain .  OBJECTIVE To determine whether neck manipulation is more effective for neck pain than mobilization . DESIGN R and omized controlled trial with blind assessment of outcome . SETTING Primary care physiotherapy , chiropractic , and osteopathy clinics in Sydney , Australia . PARTICIPANTS Patients ( N=182 ) with nonspecific neck pain less than 3 months in duration and deemed suitable for treatment with manipulation by the treating practitioner . INTERVENTIONS Participants were r and omly assigned to receive treatment with neck manipulation ( n=91 ) or mobilization ( n=91 ) . Patients in both groups received 4 treatments over 2 weeks . MAIN OUTCOME MEASURE The number of days taken to recover from the episode of neck pain . RESULTS The median number of days to recovery of pain was 47 in the manipulation group and 43 in the mobilization group . Participants treated with neck manipulation did not experience more rapid recovery than those treated with neck mobilization ( hazard ratio=.98 ; 95 % confidence interval , .66 - 1.46 ) . CONCLUSIONS Neck manipulation is not appreciably more effective than mobilization . The use of neck manipulation therefore can not be justified on the basis of superior effectiveness QUESTION What is the clinical course of a new episode of non-specific neck pain in people who are treated with multimodal physical therapies in a primary care setting ? DESIGN Observational study with 3-month follow-up , run in conjunction with a r and omised trial . PARTICIPANTS 181 adults who consulted a physiotherapist or chiropractor for a new episode of nonspecific neck pain . OUTCOME MEASURES Time to recover from the episode of neck pain , time to recover normal activity , and pain and neck-related disability at three months . Clinical and demographic characteristics were investigated as potential predictors of recovery . RESULTS Within 3 months , 53 % of participants reported complete recovery from the episode of neck pain . On a scale from 0 ( none ) to 10 ( worst ) , pain improved from 6.1 ( SD 2.0 ) at baseline to 2.5 ( SD 2.1 ) at 2 weeks and to 1.5 ( SD 1.8 ) at 3 months . On a scale from 0 ( none ) to 50 ( worst ) , disability improved from 15.5 ( SD 7.4 ) at baseline to 5.4 ( SD 6.4 ) at 3 months . Faster recovery was independently associated with better self-rated general health , shorter duration of symptoms , being a smoker , and absence of concomitant upper back pain or headache . Higher disability at 3 months was independently associated with higher disability at baseline , concomitant upper or lower back pain , older age , and previous sick leave for neck pain . CONCLUSION People who seek physical treatments for a new episode of neck pain in this primary care setting typically have high pain scores that improve rapidly after commencing treatment . Although almost half of those who seek treatment do not recover completely within three months , residual pain and disability in this group is relatively low . Physiotherapists should reassure people with a new episode of neck pain that rapid improvement in symptoms is common , modifying this advice where applicable based on risk factors & NA ; Fear‐avoidance beliefs have been identified as an important psychosocial variable in patients with chronic disability doe to low back pain . The importance of fear‐avoidance beliefs for individuals with acute low back pain has not been explored . Seventy‐eight subjects with work‐related low back pain of less than 3 weeks ' duration were studied .  Measurements of pain intensity , physical impairment , disability , nonorganic signs and symptoms , and depression were taken at the initial evaluation . Fear‐avoidance beliefs were measured with the  work and physical activity subscales of the Fear‐avoidance Beliefs Question naire .  Disability and work status were re‐assessed after 4 weeks of physical therapy . Patterns of correlation between fear‐avoidance beliefs and other concurrently‐measured variables were similar to those reported in patients with chronic low back pain . Fear‐avoidance beliefs did not explain a significant amount of the variability in initial disability levels after controlling for pain intensity and physical impairment . Fear‐avoidance beliefs about work were significant predictors of 4‐week disability and work status even after controlling for initial levels of pain intensity , physical impairment , and disability , and the type of therapy received . Fear‐avoidance beliefs are present in patients with acute low back pain , and may be an important factor in explaining the transition from acute to chronic conditions . Screening for fear‐avoidance beliefs may be useful for identifying patients at risk of prolonged disability and work absence Purpose To reduce the socio-economic burden of persistent low back pain ( LBP ) , factors influencing the progression of acute/subacute LBP to the persistent state must be identified at an early stage . Methods Prospect i ve inception cohort study of patients attending a health practitioner for their first episode of acute/subacute or recurrent LBP . Patients were assessed at baseline addressing occupational , psychological , biomedical and demographic/lifestyle factors and followed up over 6 months . Multivariate logistic regression analysis was performed separately for the variables groups of the four different domains , controlling for age , gender and body mass index . The overall predictive value was calculated for the full regression models of the different domains . Finally , all significant variables from the different domains were combined into a final predictor model . Results The final four-predictor model predicted 51 % of variance of persistent LBP and included ‘ resigned attitude towards the job ’ ( OR 1.73 ; 95 % CI 1.16–2.59 ) , ‘ social support at work ’ ( OR 0.54 ; 95 % CI 0.32–0.90 ) , ‘ functional limitation ’ ( OR 1.05 ; 95 % CI 1.01–1.10 ) and ‘ duration of LBP ’ ( OR 1.04 ; 95 % CI 1.02–1.06 ) . The accuracy of the model was 83 % , with 92 % of non-persistent and 67 % of persistent LBP patients correctly identified . Conclusions In this study of patients with acute/subacute LBP , ‘ resigned attitude towards the job ’ increased the likelihood of persistent LBP at 6 month . Addressing this factor with workplace interventions has the potential to modify the outcome . In patients experiencing ‘ social support at work ’ , the development of persistent LBP was less likely and might therefore be considered as potential re source for prevention of persistent LBP The objective of this study was to determine predictors of onset of new headache episodes and recovery from headache over one year . A population -based cohort study was conducted , comprising a baseline postal survey to a r and om sample of adults aged ≥18 years , with follow-up survey after 1 year . Risk factor data at baseline were compared with headache status at follow-up in two groups : ( i ) those free of recent headache at baseline and ( ii ) those with a recent headache at baseline . In respondents free of recent headache at baseline , previous headache [ risk ratio ( RR ) 4.15 ] , the presence of other pain at baseline ( RR 1.43 ) , severe sleep problems ( RR 1.67 ) and drinking caffeine ( RR 1.99 ) increased the risk of a new headache episode during the follow-up year . In respondents with recent headache at baseline , less severe headaches at baseline predicted recovery during the follow-up year , as did the absence of anxiety [ recovery ratio ( ReR ) 2.84 ] and of sleep problems ( ReR 2.77 ) . Risks for increased headache-related disability reflected those for onset of a new episode and these risks increased in strength for large increases in disability .  Sleep problems and caffeine consumption increase the risk of developing headache and thus provide targets for prevention . Low levels of anxiety , sleep problems and the absence of other pain improve the likelihood of recovering and remaining free from headache OBJECTIVE To investigate whether personal and work-related factors , physical performance and back-specific question naires predict return to work . A prospect i ve study identifying prognostic factors for return to work . SUBJECTS Ninety-three patients sick-listed for 8 - 12 weeks for non-specific sub-acute low back pain included in a r and omized controlled trial . METHODS Patients were examined with regard to demographic variables , a battery of back-specific question naires and physical tests before entering a r and omized controlled trial . A stepwise backward Cox regression model was established to identify the most powerful predictors . RESULTS During follow-up 78.5 % of the patients have returned to full-time work . Fear-avoidance beliefs for work ( relative risk ( RR ) for 1 SD change 0.49 ; 95 % confidence interval ( CI ) 0.38 - 0.64 ) , disability ( RR 1.39 , 95 % CI 1.02 - 1.88 ) and cardiovascular fitness ( RR 1.42 , 95 % CI 1.12 - 1.79 ) were identified as the best predictors for return to work . The prevalence of correct predictions was 69.3 % . CONCLUSION The predictors identified in the present study may reflect personal risk factors in a patient who gets acute low back pain . On the other h and , they may support that fear of pain and injury may be more disabling than pain itself , and that deconditioning is a result of altered behaviour reflecting attitudes towards low back pain in society , and information and advice given in primary healthcare Study Design . Descriptive prognostic study . Objectives . To identify outcome determinants of subacute low back pain . Summary of Background Data . The factors predicting recovery from prolonged back pain among working adults are largely unknown . Material s and Methods . One hundred sixty-four employed patients with subacute ( duration of pain 4–12 weeks ) daily low back pain were recruited from primary health care to a r and omized study . Data on potential predictive factors were collected before r and omization . In multiple regressions using repeated measures analysis , the treatment received was adjusted when determining the impact of the predictive factors . Dependent outcome variables used were pain , perceived functional disability , generic health-related quality of life , satisfaction with care , days on sick leave , use of health care , and costs of health care consumption measured , at 3- , 6- , and 12-month follow-ups . Results . Age and intensity of pain at baseline predicted most of the outcomes . The perceived risk of not recovering was a stronger determinant of outcome than gender , education , or self-rated health status ( which did not have any predictive value ) or body mass index , expectations of treatment effect , satisfaction with work , or the presence of radicular symptoms below the knee ( only slight predictive value ) . The only factors predicting the duration of sick leave were the duration of sick leave at baseline and the type of occupation . Conclusion . Age and intensity of pain are the strongest predictors of outcome . Accumulation of days on sick leave is predicted by the duration of sick leave at entry and the type of work , but not by pain , perceived disability , or satisfaction with work Context In this r and omized , controlled trial , spinal manipulation plus exercise produced outcomes for low back pain  similar to those produced by exercise alone . Yet , some patients did respond to spinal manipulation , and it would be helpful for doctors to be able to identify such patients . Contribution Patients were most likely to benefit from  spinal manipulation  if they met 4 of 5 of the following criteria : symptom duration less than 16 days , no symptoms distal to knee , score less than 19 on a fear-avoidance measure , at least 1 hypomobile lumbar segment , and at least 1 hip with more than 35 degrees of internal rotation . Implication s Clinicians may be able to use these criteria to identify patients with low back pain who are good c and i date s for  spinal manipulation . The Editors Next to the common cold , low back pain is the most common reason that individuals visit a physician 's office ( 1 ) . Billions of dollars in medical expenditures and lost labor costs for this condition are incurred each year ( 2 , 3 ) . Attempts to identify effective interventions for individuals with low back pain have been largely unsuccessful ( 4 ) . In particular , conflicting evidence exists about the effectiveness of spinal manipulation ; some r and omized trials have shown a benefit , while other trials have not ( 5 - 7 ) . These conflicting conclusions are reflected in the various recommendations in national clinical practice guidelines , with some recommending manipulation and others not ( 8) . The variety of conclusions in trials of manipulation may be attributable to the failure of research ers to adequately consider the importance of classification . Using broad inclusion criteria results in a heterogeneous sample that may include many patients for whom no benefit is expected , thus masking the intervention 's true value ( 9 , 10 ) . Consequently , developing methods for matching patients with low back pain to treatments that are most likely to benefit them has become an important research priority ( 11 ) . Clinical prediction rules are tools design ed to assist clinicians in decision making when caring for patients ( 12 ) . Several clinical prediction rules have been developed and vali date d to improve clinical decision making for the use of imaging in patients with ankle , knee , cervical spine , or minor head injuries ( 13 - 16 ) . Few studies have attempted to develop rules that establish prognosis on the basis of outcome from a specific intervention , such as spinal manipulation . Recently , Flynn and colleagues ( 17 ) developed a clinical prediction rule for identifying patients with low back pain who are likely to benefit from  manipulation .  They examined a series of patients with low back pain who received a manipulation intervention .  Five factors formed the most parsimonious set of predictors for identifying patients who achieved at least 50 % improvement in disability within 1 week with a maximum of 2 manipulation interventions ( Table 1 ) ( 17 ) . The positive likelihood ratio among patients who met at least 4 of 5 of the criteria was 24.4 ( 95 % CI , 4.6 to 139.4 ) . Table 1 . Five Criteria in the Spinal Manipulation Clinical Prediction Rule Clinical prediction rules must be vali date d in separate population s before being recommended for widespread implementation ( 18 ) . A clinical prediction rule for identifying which patients with low back pain are most likely to respond to manipulation could improve clinical efficiency and re source utilization . Thus , we aim ed to vali date the spinal manipulation clinical prediction rule in a multicenter trial . Methods We considered consecutive patients with a primary symptom of low back pain who were referred to physical therapy for participation . We used 14 physical therapists at 8 clinics in various U.S. regions and setting s ( 2 academic medical centers and smaller outpatient practice setting s ) . Most participating sites were health care facilities within the U.S. Air Force . Each site 's institutional review board approved the study before we began recruitment and data collection . Inclusion criteria were age 18 to 60 years ; a primary symptom of low back pain , with or without referral into the lower extremity ; and an Oswestry Disability Question naire ( ODQ ) score of at least 30 % . We excluded patients who had red flags for a serious spinal condition ( for example , tumor , compression fracture , or infection ) , those who had signs consistent with nerve root compression ( that is , positive straight-leg increase < 45 degrees or diminished reflexes , sensation , or lower-extremity strength ) , those who were pregnant , or those who had previous surgery to the lumbar spine or buttock . These criteria are consistent with those used in Flynn and colleagues ' study ( 17 ) and were design ed to include patients without a contraindication to manipulation . Once patients were admitted to the study , we used intention-to-treat principles , and no patient was removed for nonadherence . History and Physical Examination Before r and omization , patients completed several self-report measures and then received a st and ardized history and physical examination . We collected demographic information , including age and sex ; medical history ; and location and nature of symptoms . Self-report measures included a body diagram to assess the symptom distribution ( 19 ) . We used an 11-point pain-rating scale ranging from 0 ( no pain ) to 10 ( worst imaginable pain ) to assess current pain intensity and the best and worst level of pain during the last 24 hours ( 20 ) . We used the average of the 3 ratings . We used the Fear-Avoidance Beliefs Question naire ( FABQ ) to quantify the patient 's fear of pain and beliefs about avoiding activity ( 21 ) . Previous studies have found a high level of testretest reliability for both the FABQ physical activity and work subscales ( 22 ) . Fearavoidance beliefs have been associated with current and future disability and work loss in patients with acute ( 23 ) and chronic ( 24 ) low back pain . The modified ODQ is a region-specific disability scale for patients with low back pain ( 25 ) that has high levels of reliability , validity , and responsiveness ( 26 ) . Physical examination measures included lumbar active range of motion ( 27 ) and various tests purported to identify dysfunction in the lumbopelvic region ( 28 ) . Complete details of the physical examination are described elsewhere ( 26 ) . Specific components pertinent to validation of the rule were assessment s of segmental mobility and hip internal rotation range of motion , the performance of which is described in Appendix 1 and Appendix 3 video . Each physical therapist received a detailed manual that operationally defined each examination and treatment procedure and was trained in the study procedures by an investigator before data collection began . Supplement . Appendix 3 video : A Clinical Prediction Rule To Identify Patients with Low Back Pain Most Likely To Benefit from Spinal Manipulation Determining Status on the Clinical Prediction Rule A physical therapist who was blinded to the patients ' treatment group assignment assessed the 5 criteria in the rule ( Table 1 , Appendix 1 , and Appendix 3 video ) . To further minimize bias , examiners were not instructed in the rule 's criteria and were unaware of the patient 's status on the rule . After completion of the study , an examiner who was blinded to the patient 's treatment assignment determined the patient 's status on the rule by using the results of the baseline examination . As was done in the initial study ( 17 ) , we classified patients as positive if they met at least 4 of 5 criteria and were therefore likely to respond to manipulation . We classified patients with 3 or fewer criteria as negative . An examiner who was blinded to the patient 's status on the rule repeated the history and physical examination 1 and 4 weeks after r and omization . Patients also completed a 6-month follow-up postal question naire to assess disability , work status , and health care utilization . Treatment Groups We used a r and om-number generator to generate a r and omization list before the study began . We prepared individual , sequentially numbered index cards with the r and omization assignments . We folded the cards and placed them in sealed envelopes . After the baseline examination , the physical therapist who conducted the examination opened the next envelope , indicating the treatment group assignment . We r and omly assigned patients to 1 of 2 groups : 1 ) spinal manipulation plus an exercise program ( manipulation group ) or 2 ) an exervideocise program alone ( exercise group ) . Patients in both groups attended physical therapy twice during the first week and then once a week for the next 3 weeks , for a total of 5 sessions . We initiated treatment immediately after completion of the baseline examination , unless prohibited by time constraints ; in that case the first treatment session took place 24 to 48 hours after the baseline examination . All patients received an exercise instruction booklet that outlined the proper performance and frequency of each exercise and were instructed to perform their assigned exercise program once daily on the days that they did not attend therapy . On the basis of the benefits associated with remaining active ( 29 ) , patients in both groups were given advice to maintain usual activity within the limits of pain . Manipulation Group The treatment received by the manipulation group differed from that of the exercise group during the first 2 physical therapy sessions . During these 2 sessions , patients received high-velocity thrust spinal manipulation  and a  range-of-motion exercise only . First , the physical therapist performed the manipulation by using the same technique used by Flynn and colleagues ( 17 ) . Appendix 2 describes and Figure 1 and Appendix 3 video illustrate the procedures used to perform the manipulation technique . Figure 1 . Manipulative intervention used in developing and validating the spinal manipulation clinical prediction rule .  Exercise Group We treated patients in the exercise group with a low-stress There is a serious need to provide effective early interventions that prevent the development of persistent pain and disability . Identifying patients at risk for this development is an important step . Our aim was to explore whether distinct subgroups of individuals with similar response patterns on a screening question naire exist . Moreover , the objective was to then relate these groups to future outcomes , for example , sick leave as an impetus for developing tailored interventions that might better prevent chronic problems . A total of 363 patients seeking primary care for acute or subacute spinal pain completed the Örebro Musculoskeletal Pain Screening Question naire  and were then followed to determine outcome . Cluster analysis was used to identify subgroups . Validity was tested using 3 methods including the split-half technique . The subgroups were compared prospect ively on outcome measures obtained 1 year later . Using pain intensity , fear-avoidance beliefs , function , and mood , we found 4 distinct profiles : Fear-Avoidant , Distressed Fear-Avoidant , Low Risk , and Low Risk-Depressed Mood . These 4 subgroups were also robust in all 3 of the validity procedures . The 4 subgroups were clearly related to outcome . Although the low risk profiles had virtually no one developing long-term sick leave , the Fear-Avoidant profile had 35 % and the Distressed Fear-Avoidant profile 62 % developing long-term sick leave . Our results suggest that fear-avoidance and distress are important factors in the development of pain-related disability and may serve as a key for early identification . Providing interventions specific to the factors isolated in the profiles should enhance the prevention of persistent pain and disability
target: Several factors were found to be associated with disability at follow-up for at least two different pain symptoms .
  However , owing to insufficient studies , no generic risk factors for sick leave were identified .
  Conclusions Multiple site pain , high pain severity , older age , baseline disability and longer pain duration were identified as potential prognostic factors for disability across pain sites .
  There was limited evidence that anxiety and depression were associated with disability in patients with subacute pain , indicating that these factors may not play as large a role as expected in developing disability due to a pain condition .
background: Objective This systematic review aims to identify generic prognostic factors for disability and sick leave in subacute pain patients .