Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations The Dominant Role of Psychosocial Risk Factors in the Development of Chronic Low Back Pain Disability Preventing chronic postsurgical pain: how much of a difference makes a difference? Predictors for chronic neck and low back pain in office workers: a 1-year prospective cohort study. Pain education to prevent chronic low back pain: a study protocol for a randomised controlled trial Screening to Identify Patients at Risk: Profiles of Psychological Risk Factors for Early Intervention The efficacy of a risk factor-based cognitive behavioral intervention and electromyographic biofeedback in patients with acute sciatic pain. An attempt to prevent chronicity. A controlled study of the effects of an early intervention on acute musculoskeletal pain problems Treatment- and Cost-Effectiveness of Early Intervention for Acute Low-Back Pain Patients: A One-Year Prospective Study Can Chronic Disability Be Prevented?: A Randomized Trial of a Cognitive-Behavior Intervention and Two Forms of Information for Patients With Spinal Pain Risk factors for chronic pain following breast cancer surgery: a prospective study. Factors associated with the development of chronic pain after surgery for breast cancer: a prospective cohort from a tertiary center in the United States. Even Worse — Risk Factors and Protective Factors for Transition from Chronic Localized Low Back Pain to Chronic Widespread Pain in General Practice: A Cohort Study Stay@Work: Participatory Ergonomics to prevent low back and neck pain among workers: design of a randomised controlled trial to evaluate the (cost-)effectiveness The secondary prevention of low back pain: a controlled study with follow-up A review and proposal for a core set of factors for prospective cohorts in low back pain: a consensus statement. Risk factors for neck pain in office workers: a prospective study National Institutes of Health State-of-the-Science Conference Statement: Multivitamin/Mineral Supplements and Chronic Disease Prevention ISSLS Prize Winner: Early Predictors of Chronic Work Disability: A Prospective, Population-Based Study of Workers With Back Injuries A Prospective Investigation of Biomechanical Risk Factors for Patellofemoral Pain Syndrome Acceptance and Commitment Therapy for Prevention of Chronic Postsurgical Pain and Opioid Use in At-Risk Veterans: A Pilot Randomized Controlled Study. Chronicity of Back Problems During Working Life Preamputation pain and acute pain predict chronic pain after lower extremity amputation.
A number of pharmacologic treatments examined in recent r and omized clinical trials ( RCTs ) have failed to show statistically significant superiority to placebo in conditions in which their efficacy had previously been demonstrated . Assuming the validity of previous evidence of efficacy and the comparability of the patients and outcome measures in these studies , such results may be a consequence of limitations in the ability of these RCTs to demonstrate the benefits of efficacious analgesic treatments vs placebo ( “ assay sensitivity ” ) . Efforts to improve the assay sensitivity of analgesic trials could reduce the rate of falsely negative trials of efficacious medications and improve the efficiency of analgesic drug development . Therefore , an Initiative on Methods , Measurement , and Pain Assessment in Clinical Trials consensus meeting was convened in which the assay sensitivity of chronic pain trials was review ed and discussed . On the basis of this meeting and subsequent discussion s , the authors recommend consideration of a number of patient , study design , study site , and outcome measurement factors that have the potential to affect the assay sensitivity of RCTs of chronic pain treatments . Increased attention to and research on method ological aspects of clinical trials and their relationships with assay sensitivity have the potential to provide the foundation for an evidence ‐based approach to the design of analgesic clinical trials and expedite the identification of analgesic treatments with improved efficacy and safety Study Design An inception cohort design was used in which 421 patients were evaluated systematic ally with a st and ard battery of psychosocial assessment tests ( Structured Interview for DSM-III-R Diagnosis , Minnesota Multiphasic Personality Inventory , and Million Visual Pain Analog Scale ) within 6 weeks of acute back pain onset . Objectives The present study evaluated the predictive power of a comprehensive assessment of psychosocial and personality factors in identifying acute low back pain patients who subsequently develop chronic pain disability problems  ( as measured by job-work status at 1-year follow-up evaluation ) . Summary of Background Data There has been a relative paucity of prospect i ve research in the United States comprehensively evaluating potential psychoscial risk factors that are associated with those injured workers who subsequently fail to return to work and productivity after 1 year because of low back pain disability . Such research has been quite limited because of the time and cost involved in conducting prospect i ve studies . Methods All study patients were symptomatic with lumbar pain syndrome for no more than 6 weeks , These acute patients were tracked every 3 months , culminating in a structured telephone interview being conducted 1 year after the initial evaluation to document return-to-work status . Results Logistic regression analyses , conducted to differentiate between patients who were back at work after 1 year versus patients who were not because of the original back injury , revealed the importance of three psychosocial measures : self-reported pain and disability , scores on Scale 3 of the Minnesota Multiphasic Personality Inventory , and workers ' compensation and personal injury insurance status . The model generated correctly classified 90.7 % of the cases . Results revealed that major psychopathology , such as depression and substance abuse , did not precede or cause the development of chronic pain disability . Conclusions These results show the presence of a robust “ psychosocial disability factor ” that is associated with those injured workers who are likely to develop chronic low back pain disability problems .  Based on these data , a statistical algorithm has been generated that can identify those acute patients who will require early intervention to prevent the development of chronic disability . The second major result is that preinjury or concomitant psychopathology does not appear to predispose patients to chronic pain disability , although high rates of psychopathology have been shown in chronic low back pain . Future research should be directed at emotional vulnerability and psychosocial events in the period after the injury that may lead to chronicity AFTER surgical procedures such as amputation , mastectomy , and thoracotomy , as many as 60 % of patients continue to experience pain for at least 6 months , with approximately 10 % reporting severe pain . These chronic postsurgical pain conditions have major adverse effects on health-related quality of life , including physical functioning and emotional well-being . Unfortunately , the efficacy of existing treatments is limited and many patients remain refractory to currently available therapies . For this reason , the development of interventions that prevent chronic pain after surgery has the potential to have a major impact on public health . Substantial attention has been devoted to the hypothesis that the incidence of chronic postsurgical pain can be reduced by “ preventive ” analgesia , and the benefits of preoperative , intraoperative , and postoperative analgesic interventions have been investigated alone and in various combinations . Although the results of these studies suggest that reduced acute pain and analgesic consumption can extend beyond the duration of action of the preventive analgesic interventions , there is little evidence that chronic postsurgical pain can be prevented . Placebocontrolled r and omized clinical trials are needed to determine what specific analgesic interventions are efficacious for preventing chronic pain after what types of surgery for which patients . – 6 A critical component of future clinical trials will involve determining the clinical importance of the benefits of preventive analgesia . The results of recent studies and consensus recommendations provide a foundation for interpreting the benefits of chronic pain treatment ; however , little attention has been paid to determining what magnitudes of chronic pain prevention are clinical ly meaningful . As is true of treatment benefits , evaluating the importance of preventive benefits involves a frequently misunderstood distinction between the interpretation of the clinical importance of individual patient benefits and the interpretation of the clinical importance of group differences . The results of multiple studies have shown that individual patients consider chronic pain reductions of at least 30 % on numerical or visual analog scales to be moderately clinical ly important , whereas reductions of at least 50 % represent substantial improvements . These thresholds are based on ratings by patients of their own improvement at the end of chronic pain trials , and consistent results have been found across different chronic pain conditions and in patients administered active treatments as well as placebo . Criteria for identifying clinical ly meaningful individual improvements are necessary to categorize patients as “ responders ” or “ nonresponders , ” which makes it possible to compare the percentages of patients who achieve clinical ly important outcomes between different treatment and comparison groups . Unfortunately , criteria for determining clinical ly important improvements in patients being treated for chronic pain can not be extrapolated to those undergoing perioperative analgesic interventions to prevent chronic pain . Currently , there are no data that make it possible to determine whether patients who have not experienced chronic pain would consider its prevention after surgery important enough to undergo preoperative , intraoperative , and postoperative analgesic interventions . Evaluations of individual patient improvements associated with chronic pain treatments have emphasized pain reduction , but patients considering the prevention of conditions for which their risk is relatively low can also be expected to be particularly concerned with the adverse effects , safety risks , inconvenience , and costs of the preventive intervention . It is likely that an efficacious preventive analgesia would not completely prevent chronic pain but would instead partially reduce its incidence , intensity , or duration . Such partial preventive benefits would , of course , be even harder for patients to evaluate ; for example , would patients consider reducing pain intensity 6 months after surgery from a daily average of 4 to 2 on a 0–10 scale a clinical ly important benefit ? Would this evaluation change if this reduction in pain intensity at 6 months is known to last for another 2 yr , or if the preventive intervention requires that patients take a medication that causes sedation , nausea , and constipation for 7 days before and 30 days after their operation ? Evaluations of the clinical importance of preventive analgesia must reflect the magnitude of the reductions in chronic pain incidence , intensity , or duration that the intervention would provide . However , even small reductions in the incidence or intensity of a chronic pain condition that can last for months or even years might be considered clinical ly important by patients if Accepted for publication November 17 , 2009 . The authors are not supported by , nor maintain any financial interest in , any commercial activity that may be associated with the topic of this article OBJECTIVE All occupations expose workers to varied and unique conditions . The nature of work has been recognized as influencing the health of workers . Whether predictors for chronic neck and low back pain would be occupation-specific is unknown . This study aim ed to identify predictors for chronic neck and low back pain in a cohort of office workers . METHODS A prospect i ve study was carried out among 669 healthy office workers . At baseline , risk factors were assessed using a question naire and st and ardized physical examination . A symptomatic case was defined as an individual who reported pain greater than 30 mm on a 100-mm VAS , and chronic pain was defined as experiencing ongoing neck or low back pain for greater than 3 months over the past 6 months . Two regression models were built to analyze the risk factors for developing chronic neck and low back pain . RESULTS Of the sample , 17 and 27 % of office workers who reported a new onset of neck or low back pain developed chronicity , respectively . Predictors for chronic neck pain were high body mass index , frequent neck extension during the work day , high initial pain intensity , and high psychological job dem and s. The development of chronic low back pain was associated with history of low back pain and high initial pain intensity . CONCLUSIONS The findings suggest that predictors for chronic musculoskeletal pain in a sub population may be a subset of predictors identified in a general population or occupation specific . Successful management to prevent chronic musculoskeletal pain may also need to consider the patient 's occupation Introduction Low back pain ( LBP ) is the leading cause of disability worldwide . Of those patients who present to primary care with acute LBP , 40 % continue to report symptoms 3 months later and develop chronic LBP . Although it is possible to identify these patients early , effective interventions to improve their outcomes are not available . This double-blind ( participant/ outcome assessor ) r and omised controlled trial will investigate the efficacy of a brief educational approach to prevent chronic LBP in ‘ at-risk ’ individuals . Methods / analysis Participants will be recruited from primary care practice s in the Sydney metropolitan area . To be eligible for inclusion participants will be aged 18–75 years , with acute LBP ( < 4 weeks ’ duration ) preceded by at least a 1 month pain-free period and at-risk of developing chronic LBP . Potential participants with chronic spinal pain and those with suspected serious spinal pathology will be excluded . Eligible participants who agree to take part will be r and omly allocated to receive 2 × 1 h sessions of pain biology education or 2 × 1 h sessions of sham education from a specially trained study physiotherapist . The study requires 101 participants per group to detect a 1-point difference in pain intensity 3 months after pain onset . Secondary outcomes include the incidence of chronic LBP , disability , pain intensity , depression , healthcare utilisation , pain attitudes and beliefs , global recovery and recurrence and are measured at 1 week post-intervention , and at 3 , 6 and 12 months post LBP onset . Ethics/dissemination Ethical approval was obtained from the University of New South Wales Human Ethics Committee in June 2013 ( ref number HC12664 ) . Outcomes will be disseminated through publication in peer- review ed journals and presentations at international conference meetings . Trial registration number https://www.anzctr.org.au/Trial/ Registration /Trial Review 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 STUDY DESIGN An investigation of the efficacy of an individually scheduled , risk factor-based cognitive behavioral therapy and a st and ardized electromyographic biofeedback intervention in the prevention of chronicity in patients with acute sciatica and psychosocial risk factors for chronicity . OBJECTIVES To investigate the possibility of enhancing pain relief and preventing chronicity in patients with acute sciatica , based on a screening for psychosocial high-risk factors of chronification . SUMMARY OF BACKGROUND DATA Psychological interventions were evaluated mainly in patients with chronic low back pain . Numerous r and omized trials have demonstrated their efficacy , whereas the amount of pain relief was found to be marginal . METHODS Subjective and behavioral outcome parameters were compared with the respective parameters in age- , gender- , and diagnosis-matched high- and low-risk patients . No additional behavioral treatment for in-patient medical therapy was offered to the patients . Outcome of these patients also was compared with that of a group of refusers of behavioral therapy .  Psychological , functional , and behavioral variables were measured before and after treatment and at 3- , 6- , 12- and 18-month follow-up visits . Changes over time , group differences , and possible group x time interactions were analyzed by analysis of variance and nonparameteric comparisons . RESULTS Data analysis showed a statistically and clinical ly significant , beneficial effect of both behavioral interventions . However , risk factor-based cognitive behavioral therapy was superior to electromyographic biofeedback intervention with respect to pain relief and application for early retirement . The cognitive behavioral therapy showed a similar good outcome ( e.g. , 90 % showed a clinical significant pain reduction ) as the low-risk patients ( 83 % pain reduction ) . High risk patients and refusers of therapy showed a poor outcome in pain ( 33 % and 20 % pain reduction , respectively ) , disability , and work performance . CONCLUSIONS Individually scheduled , risk factor-based cognitive behavior therapy could be a beneficial treatment modality , which can be offered , in addition to a medical treatment , to patients with acute sciatica and psychosocial high risk factors for chronicity . It may be an effective way to prevent chronification in these patients & NA ; Current conceptions of chronic pain clearly suggest that proper care at the acute stage should prevent the development of chronic problems . Patients ( 198 ) seeking help for acute musculoskeletal pain ( MSP ) , e.g. , back and neck pain participated in two studies of the effects of an Early Active intervention which underscored ‘ well ’ behavior and function compared to a Treatment as Usual control group . The quantity of the Early Active treatment was a median of 1 doctor 's appointment and 3 meetings with a physical therapist .  Study I concerned patients with a prior history of sick‐listing for MSP , while study II involved patients with no prior history of MSP . Treatment satisfaction , pain experience , activities and sickness absenteeism were assessed before , after and at a 12‐month follow‐up . In study I ( patients with a history of MSP ) , the results showed significant improvements for both groups , but virtually no differences between the groups . Similarly , in study II ( no history of MSP ) both groups demonstrated significant improvements e.g. , for pain intensity and activity levels . However , the Early Active treatment result ed in significantly less sick‐listing relative to the control group . Moreover , the risk of developing chronic ( > 200 sick days ) pain was 8 times lower for the Early Activation group . This investigation shows that relatively simple changes in treatment result in reduced sickness absenteeism for ‘ first‐time ’ sufferers only . Consequently , the content and timing of treatment for pain appear to be crucial . Properly administered early intervention may therefore decrease sick leave and prevent chronic problems , thus saving considerable re sources In an attempt to prevent acute low-back pain from becoming a chronic disability problem , an earlier study developed a statistical algorithm which accurately identified those acute low-back pain patients who were at high risk for developing such chronicity . The major goal of the present study was to evaluate the clinical effectiveness of employing an early intervention program with these high-risk patients in order to prevent the development of chronic disability at a 1-year follow-up . Approximately 700 acute low-back pain patients were screened for their high-risk versus low-risk status . On the basis of this screening , high-risk patients were then r and omly assigned to one of two groups : a functional restoration early intervention group ( n = 22 ) , or a nonintervention group ( n = 48 ) . A group of low-risk subjects ( n = 54 ) who did not receive any early intervention  was also evaluated . All these subjects were prospect ively tracked at 3-month intervals starting from the date of their initial evaluation , culminating in a 12-month follow-up . During these follow-up evaluations , pain disability and socioeconomic outcomes ( such as return-to-work and healthcare utilization ) were assessed . Results clearly indicated that the high-risk subjects who received early intervention displayed statistically significant fewer indices of chronic pain disability on a wide range of work , healthcare utilization , medication use , and self-report pain variables , relative to the high-risk subjects who do not receive such early intervention . In addition , the high-risk nonintervention group displayed significantly more symptoms of chronic pain disability on these variables relative to the initially low-risk subjects . Cost-comparison savings data were also evaluated . These data revealed that there were greater cost savings associated with the early intervention group versus the no early intervention group . The overall results of this study clearly demonstrate the treatment- and cost-effectiveness of an early intervention program for acute low-back pain patients Study Design . A r and omized controlled design superimposed on treatment as usual was used to compare the effects of a cognitive-behavior intervention aim ed at preventing chronicity with two different forms of information . Objective . To develop a coping-oriented preventive intervention applicable in primary care , and to compare its impact with educational information . Summary of Background Data . Preventing long-term disability result ing from spinal pain has proved difficult . The information provided by health care professions and early interventions aim ed at preventing long-term disability may be important , but little scientific evidence exists concerning their use . Methods . A protocol for a six-session cognitive-behavior group intervention was developed on the basis of earlier research . The main focus was to prevent long-term disability by changing patients ’ behaviors and beliefs so they can cope better with their problems . Comparison groups received either a pamphlet shown earlier to have an effect , or a more extensive information package consisting of six installments . All the groups continued to receive treatment as usual in primary care . There were 243 patients with acute or subacute spinal pain who perceived that they were at risk for developing a chronic problem . These patients were r and omized to the cognitive-behavioral intervention or one of the two information groups . Because the aim was to prevent long-term disability , the key outcome variables at the 1-year follow-up assessment were sick absenteeism and health care use . Other variables were pain , function , fear-avoidance beliefs , and cognitions . Results . The comparison groups reported benefits . However , the risk for a long-term sick absence developing was lowered ninefold for the cognitive-behavior intervention group as compared with the risk for the information groups ( relative risk , 9.3 ) . Participants in the cognitive-behavior group also reported a significant decrease in perceived risk . In addition , the cognitive-behavior group demonstrated a significant decrease in physician and physical therapy use as compared with two groups receiving information , in which such use increased . All three groups tended to improve on the variables of pain , fear-avoidance , and cognitions . Conclusions . This study demonstrates that a cognitive-behavior group intervention can lower the risk of a long-term disability developing . These findings underscore the significance of early interventions that specifically aim to prevent chronic problems . This approach might be applied to primary care setting UNLABELLED Chronic pain following breast cancer surgery is associated with decreased health-related quality of life and is a source of additional psychosocial distress in women who are already confronting the multiple stresses of cancer . Few prospect i ve studies have identified risk factors for chronic pain following breast cancer surgery . Putative demographic , clinical , and psychosocial risk factors for chronic pain were evaluated prospect ively in 95 women scheduled for breast cancer surgery . In a multivariate analysis of the presence of chronic pain , only younger age was associated with a significantly increased risk of developing chronic pain 3 months after surgery . In an analysis of the intensity of chronic pain , however , more invasive surgery , radiation therapy after surgery , and clinical ly meaningful acute postoperative pain each independently predicted more intense chronic pain 3 months after surgery . Preoperative emotional functioning variables did not independently contribute to the prediction of either the presence or the intensity of chronic pain after breast cancer surgery . These findings not only increase underst and ing of risk factors for chronic pain following breast cancer surgery and the processes that may contribute to its development but also provide a basis for the development of preventive interventions . PERSPECTIVE Clinical variables and severe acute pain were risk factors for chronic pain following breast cancer surgery , but psychosocial distress was not , which provides a basis for hypothesizing that aggressive management of acute postoperative pain may reduce chronic pain Chronic pain has been shown to affect up to 60 % of patients undergoing surgery for breast cancer . Besides younger age , other risk factors for the development of chronic pain have not been consistent in previous studies . The objective of the current investigation was to detect the prevalence and risk factors for the development of chronic pain  after breast cancer surgery by examining a patient population from a tertiary cancer center in the United States . The study was a prospect i ve observational cohort study . Subjects were evaluated at least 6 months after the surgical procedure . Subjects responded to the modified short form Brief pain inventory and the short form McGill pain question naire to identify and characterize pain . Demographic , surgery , cancer treatment , and perioperative characteristics were recorded . Propensity matching regression analysis were used to examine risk factors associated with the development of chronic pain .  300 patients were included in the study . 110 reported the presence of chronic pain .  Subjects with chronic pain reported median ( interquartile range [ IQR ] ) rating of worst pain in the last 24 hours of 4 ( 2 - 5 ) and a median ( IQR ) rating on average pain in the last 24 hours of 3 ( 1 - 4 ) on a 0 - 10 numeric rating scale . Independent risk factors associated with the development of chronic pain were age , OR ( 95 % CI ) of 0.95 ( 0.93 - 0.98 ) and axillary lymph node dissection , 7.7 ( 4.3 - 13.9 ) but not radiation therapy , 1.05(0.56 - 1.95 ) . After propensity matching for confounding covariates , radiation was still not associated with the development of chronic pain . Chronic pain after mastectomy continues to have a high prevalence in breast cancer patients . Younger age and axillary lymph node dissection but not radiation therapy are risk factors for the development of chronic pain . Preventive strategies to minimize the development of chronic pain are highly desirable Study Design . Prospect i ve cohort study with patients with chronic low back pain ( CLBP ) at primary care setting . Objective . The aim of our study was to identify predictors for transition from localized CLBP to chronic widespread pain in general practice . In contrast to the typically investigated risk factors , this study also focuses intensively on protective factors , which decrease the probability of chronic widespread pain . For this , we investigated the re sources resilience and coping strategies , which are suspected as potential protective factors for incident chronic pain syndromes . Summary of Background Data . In primary care , about a quarter of patients with CLBP experience chronic widespread pain ( CWP ) . Methods . Patients experiencing localized CLBP were included and evaluated after a 6- and 12-month follow-up period regarding the development of CWP . Potential risk factors (  sociodemographic data , pain characteristics , depression , anxiety , somatization ) , protective factors ( resilience , coping strategies ) , and sample characteristics were assessed at baseline . Predictor identification was done by multivariate logistic regression analysis . Results . The 1-year incidence for the onset of CWP among patients with CLBP was 23.8 % . We identified the 3 risk factors , female sex , long duration of back pain , and a high rate of psychosomatic symptoms , for the onset of CWP among patients with CLBP . Coping re sources and resilience had no impact on the transition from CLBP to CWP . Conclusion . The results suggest that CWP is no independent entity but rather a particularly negative occurrence on a continuum of chronic pain . Processes of somatization play a major role in the development of this extreme . Level of Evidence : Background Low back pain ( LBP ) and neck pain ( NP ) are a major public health problem with considerable costs for individuals , companies and society . Therefore , prevention is imperative . The Stay@Work study investigates the (cost-)effectiveness of Participatory Ergonomics ( PE ) to prevent LBP and NP among workers . Methods In a r and omised controlled trial ( RCT ) , a total of 5,759 workers working at 36 departments of four companies is expected to participate in the study at baseline . The departments consisting of about 150 workers are pre-stratified and r and omised . The control departments receive usual practice and the intervention departments receive PE . Within each intervention department a working group is formed including eight workers , a representative of the management , and an occupational health and safety coordinator . During a one day meeting , the working group follows the steps of PE in which the most important risk factors for LBP and NP , and the most adequate ergonomic measures are identified on the basis of group consensus . The implementation of ergonomic measures at the department is performed by the working group . To improve the implementation process , so-called ' ergocoaches ' are trained . The primary outcome measure is an episode of LBP and NP . Secondary outcome measures are actual use of ergonomic measures , physical workload , psychosocial workload , intensity of pain , general health status , sick leave , and work productivity . The cost-effectiveness analysis is performed from the societal and company perspective . Outcome measures are assessed using question naires at baseline and after 6 and 12 months . Data on the primary outcome as well as on intensity of pain , sick leave , work productivity , and health care costs are collected every 3 months . Discussion Prevention of LBP and NP is beneficial for workers , employers , and society . If the intervention is proven (cost-)effective , the intervention can have a major impact on LBP and NP prevention and , thereby , on work disability prevention . Results are expected in 2010.Trial registration IS RCT & NA ; The current investigation studied the effectiveness of a secondary prevention program for nurses with back pain who were deemed at risk for developing a chronic problem . A 2 × 3 repeated measures design was employed with 2 groups and 3 assessment periods . The treatment group received an intervention design ed to reduce current problems , but above all to prevent reinjury and minor pains from becoming chronic medical problems , and it included a physical and behavioral therapy package . The control group was placed on a waiting‐list . Results indicated that the treatment group had significantly greater improvements than the control group for pain intensity , anxiety , sleep quality and fatigue ratings , observed pain behavior , activities , mood , and helplessness . These differences were generally maintained at the 6 month follow‐up . In addition , the treatment group broke a trend for increasing amounts of pain‐related absenteeism , while the control group did not . Taken as a whole , the results suggest that a secondary prevention program aim ed at altering life style factors may represent an effective method for dealing with musculoskeletal pain problems Introduction The Multinational Musculoskeletal Inception Cohort Study ( MMICS ) Statement is a consensus statement aim ed at improving the quality of prospect i ve investigations into the transition from early stages of low back pain ( LBP ) to persistent problems . The statement aims to help improve the quality of such studies by recommending an agreed minimal list of measures for inclusion in baseline data collection . The MMICS Statement is primarily aim ed at research ers who want to investigate prognosis in LBP , and this will allow data from cohorts to be pooled and will facilitate comparisons between different health care systems . One approach to preventing acute new episodes of LBP ( up to 3 weeks from onset ) from developing into persistent disabling pain is to identify those individuals with LBP who are most likely to progress to chronic disability . Targeting interventions at those at highest risk could reduce the population burden of chronic LBP . A wide range of baseline parameters have been associated with poor outcome in inception cohort studies ( 1–6 ) . Few existing studies have been of sufficient size and method ologic rigor to produce conclusive findings . Even in method ologically robust studies , baseline factors only account for a small proportion of the variance in outcome ( 7 ) , typically around 30 % . Systematic review s of the literature could not pool data because studies used different measurements ( 1–3 ) . Despite some information on physical , psychosocial , and work-related risk factors , it has not been possible to adequately estimate the comparative impact of individual psychosocial and societal factors on the transition from acute to persistent disabling LBP . How to address this problem was one focus of the VI International Forum for Primary Care Research in Low Back Pain held in April 2003 . A steering group for the collaboration was appointed , and 8 national team leaders volunteered to recruit teams of national experts . Three additional team leaders were recruited by the steering group ( Australia , France , and Germany ) . Independent experts were invited to advise on the quality of the MMICS process . The MMICS steering group , located in the UK , met regularly and included expert research ers in clinical and outcome factors in back pain ( AB ) , work-related issues in back pain ( AKB ) , psychosocial aspects of back pain ( TP and RS ) , and general practice aspects of back pain ( MU ) . The MMICS Statement set out to include 1 ) a minimal but comprehensive number of predictor factors based on current evidence and theory ; 2 ) appropriate measurement instruments for agreed predictor factors based on their clinometric properties , availability , and practical characteristics ; and 3 ) a minimum set of followup measures , including recommendations about measurement and timing Background Persisting neck pain is common in society . It has been reported that the prevalence of neck pain in office workers is much higher than in the general population . The costs to the worker , employer and society associated with work-related neck pain are known to be considerable and are escalating . The factors that place office workers at greater risk of developing neck pain are not understood . The aim of this study is to investigate the incidence and risk factors of work-related neck pain in Australian office workers . Methods / design We will conduct a prospect i ve cohort study . A cohort of office workers without neck pain will be followed over a 12 month period , after baseline measurement of potential risk factors . The categories of risk factors being evaluated are physical ( cervical spine posture , range of movement , muscle endurance and exercise frequency ) , demographic ( age , sex ) , work environment ( sitting duration , frequency of breaks ) and psychosocial ( psychological distress and psychosocial work factors ) . Cox regression analysis will be used to identify risk factors associated with work-related neck pain , and will be expressed as hazard ratios with 95 % confidence intervals . The data will also enable the incidence of neck pain in this population to be estimated . Discussion In addition to clarifying the magnitude of this occupational health problem these data could inform policy in workplaces and provide the basis for primary prevention of neck pain in office workers , targeting the identified risk factors National Institutes of Health ( NIH ) consensus and state-of-the-science statements are prepared by independent panels of health professionals and public representatives on the basis of 1 ) the results of a systematic literature review prepared under contract with the Agency for Healthcare Research and Quality ( AHRQ ) , 2 ) presentations by investigators working in areas relevant to the conference questions during a 2-day public session , 3 ) questions and statements from conference attendees during open discussion periods that are part of the public session , and 4 ) closed deliberations by the panel during the remainder of the second day and the morning of the third . This statement is an independent report of the panel and is not a policy statement of the NIH or the federal government . The statement reflects the panel 's assessment of medical knowledge available at the time the statement was written . Thus , it provides a snapshot in time of the state of knowledge on the conference topic . When reading the statement , keep in mind that new knowledge is inevitably accumulating through medical research . At least half of American adults take a dietary supplement , the majority of which are multivitamin/multimineral ( MVM ) supplements . As more and more Americans seek strategies for maintaining good health and preventing disease , and as the marketplace offers an increasing number of products to fulfill that desire , it is important that consumers have the best possible information to make their choices . Assessing the available scientific evidence on the benefits of MVM supplement use for chronic disease prevention , identifying the gaps in the evidence , and recommending an appropriate research agenda to meet the shortfalls are subjects considered in this report . The word vitamine was coined in 1912 , as an abbreviated term meant to capture the notion of important factors in the diet , or vital amines . This was preceded more than 150 years earlier by British navy physician James Lind 's discoveryin the first recorded controlled trialthat citrus juice , a good source of what was found 2 centuries later to be vitamin C , could prevent scurvy in sailors . In 1913 , the first vitamin was isolated : thiamin , the deficiency of which caused beriberi . Thirteen vitamins and 15 essential minerals have now been identified as important to human nutrition . Large-scale fortification of diets began in the United States with the addition of iodine to table salt in 1924 to prevent goiter , followed by the addition of vitamin D to milk in 1933 to prevent rickets and the addition of thiamin , riboflavin , niacin , and iron to flour in 1941 . Multivitamin/multimineral products providing more than vitamins A and D became available in pharmacies and grocery stores in the mid-1930s . In the early 1940s , the first MVM tablet was introduced . Although clinical deficiency of vitamins or minerals , other than iron , is now uncommon in the United States , growth in supplement use has accelerated rapidly with marketing spurred by cl aims some based on scientific studies that chronic conditions could be prevented or treated by supplement use . Annual sales of supplements to Americans are now reported at about $ 23 billion , a substantial share of which is spent on vitamins and minerals . Because of such widespread use of MVM , increasing public and medical confusion over apparently contradictory results from studies , and reports of possible adverse effects from overuse in certain circumstances , the Office of Dietary Supplements and the Office of Medical Applications of Research of the NIH convened a State-of-the-Science Conference on Multivitamin/Mineral Supplements and Chronic Disease Prevention , held on 1517 May 2006 , in Bethesda , Maryl and . The goal of the conference was to assess the evidence available on MVM use and outcomes for chronic disease prevention in the generally healthy population of adults and to make recommendations for future research . The conference focused on vitamins and minerals and did not deal with botanicals , hormones , or other supplements . It also did not address the treatment of vitamin or mineral deficiencies . Except for considerations of safety , the conference also did not review issues of primary relevance to pregnant women or children . Specifically , the conference explored the following key questions : 1 ) What are the current patterns and prevalence of the public 's use of MVM supplements ? 2 ) What is known about the dietary nutrient intake of MVM users versus nonusers ? 3 ) What is the efficacy of single vitamin/mineral supplement use in chronic disease prevention ? 4 ) What is the efficacy of MVM  in chronic disease prevention in the general population of adults ? 5 ) What is known about the safety of MVM  for the generally healthy population ? and 6 ) What are the major knowledge gaps and research opportunities regarding MVM use ? During the first 2 days of the conference , experts presented information on each of the key questions . After weighing the scientific evidence , including the data presented by the speakers and a formal evidence report commissioned through AHRQ , an independent panel prepared and presented a draft of this state-of-the-science statement addressing the conference questions . The evidence report prepared for the conference is available at www.ahrq.gov/clinic/tp/multivittp.htm . For the purpose of this statement , the term MVM refers to any supplement containing 3 or more vitamins and minerals but no herbs , hormones , or drugs , with each component at a dose less than the tolerable upper level determined by the Food and Nutrition Boardthe maximum daily intake likely to pose no risk for adverse health effects . Our review also included studies of the relationship of single-nutrient supplements and 2-nutrient supplements to certain disease outcomes . The term primary prevention refers to preventing the development of disease in a person who does not have the disease in question . The chronic conditions assessed include cancer ; age-related sensory loss ; and cardiovascular , endocrine , neurologic , musculoskeletal , gastroenterologic , renal , and pulmonary diseases . A word is warranted about the nature of the evidence base considered by the panel . The range of vitamins and minerals of possible interest was so broad that the conference planning committee chose to focus the evidence report on nutrients for which the potential for impact had been most strongly suggested and on conditions for which supplements were thought to have the most potential influence . The planning committee also limited the scope of the evidence report to consideration of r and omized , controlled trials ( RCTs ) , which are generally considered the gold st and ard for evidence -based decision making . These are studies in which participants are allocated by chance alone to receive or not to receive 1 of 2 or more clinical interventions . For example , while folate supplementation was initially shown to decrease the risk for neural tube defects in animal studies , outcome data in nonhuman models were not considered sufficient evidence on which to base policy recommendations . At the next level of evidence , observational studies in humans suggested efficacy of folate supplementation to prevent such defects . However , these were criticized because they were not r and omized and were potentially subject to bias . Not until these findings were confirmed by RCTs in humans was public policy implemented , including fortification of cereal grains with folate . An observational study is one in which the exposure or treatment of interest is not assigned to the participant by the investigator . Such studies suggested that -carotene intake might protect against the development of some types of cancer . However , RCTs of -carotene supplementation not only showed no benefit , they also found an increased risk for lung cancer in persons who smoked cigarettes or who were exposed to asbestos . These examples illustrate both the risk of relying only on observational studies and the advantage of RCTs in identifying both benefits and risks of MVM supplementation . Limiting the focus of our statement to RCTs has some inherent limitations , given the potential of other types of studies to provide important insights . Observational studies , for example , are particularly useful for generating hypotheses , defining adverse effects , and documenting long-term treatment consequences . They are often essential precursors to the well-conducted RCTs important for policy formation . Our principal recommendations focus on the compelling research activities that must be supported to better inform the decisions that millions of Americans are making each day to use or not to use MVM supplements to prevent chronic disease . At the same time , mindful of the constraints of the available evidence base , we have also taken care not to make premature recommendations about whether generally healthy Americans should or should not take MVM supplements . Because of the need for more reliable information on MVMs , we have made strong recommendations for research and for increased U.S. Food and Drug Administration ( FDA ) oversight of the MVM industry . 1 . What Are the Current Patterns and Prevalence of the Public 's Use of MVM Supplements ? More than half of American adults take dietary supplements in the belief that they will make them feel better , give them greater energy , improve their health , and prevent and treat disease . The use of supplements has been steadily increasing , and growth appears likely to continue . Currently , users spend more than $ 23 billion per year on supplements , and among this supplement-using population , MVM is the major category of supplements , used by about one third of Americans . Uncertainty remains in estimating prevalence of use because of problems defining these products ; increasing complexity in the formulation of supplements , including more non-MVM components and specialized formulas ; and varying frequency of use . It appears that use is higher Study Design . Prospect i ve population -based cohort study . Objective . To identify early predictors of chronic work disability after work-related back injury . Summary of Background Data . Identification of early predictors of prolonged disability after back injury could increase underst and ing concerning the development of chronic , disabling pain , and aid in secondary prevention . Few studies have examined predictors across multiple domains in a large , population -based sample . Methods . Workers ( N = 1885 ) were interviewed 3 weeks ( average ) after su bmi tting a lost work-time cl aim for a back injury .  Sociodemographic , employment-related , pain and function , clinical , health care , administrative/legal , health behavior , and psychological domain variables were assessed via worker interviews , medical records , and administrative data bases . Logistic regression analyses identified early predictors of work disability compensation 1 year after cl aim su bmi ssion . Results . Significant baseline predictors of 1-year work disability in the final multidomain model were injury severity ( rated from medical records ) , specialty of the first health care provider seen for the injury ( obtained from administrative data ) , and worker-reported physical disability ( Rol and -Morris disability question naire ) , number of pain sites , “ very hectic ” job , no offer of a job accommodation ( e.g. , light duty ) , and previous injury involving a month or more off work . The model showed excellent ability to discriminate between workers who were/were not disabled at 1 year ( area under the receiver operating characteristic curve = 0.88 , 95 % CI = 0.86–0.90 ) . Conclusion . Among workers with new lost work-time back injury cl aims , risk factors for chronic disability include radiculopathy , substantial functional disability , and to a lesser extent , more widespread pain and previous injury with extended time off work . The roles of employers and health care providers also seem important , supporting the need to incorporate factors external to the worker in models of the development of chronic disability and in disability prevention efforts Background Patellofemoral pain syndrome is one of the most common chronic knee injuries ; however , little research has been done to determine the risk factors for this injury . Hypothesis Altered lower extremity kinematics and kinetics , decreased strength , and altered postural measurements will be risk factors . Study Design Cohort study ( prognosis ) ; Level of evidence , 2 . Methods A total of 1597 participants were enrolled in this investigation and prospect ively followed from the date of their enrollment ( July 2005 , July 2006 , or July 2007 ) through January 2008 , a maximum of 2.5 years of follow-up . Each participant underwent baseline data collection during their pre-freshman summer at the United States Naval Academy . Baseline data collection included 3-dimensional motion analysis during a jump-l and ing task , 6 lower extremity isometric strength tests , and postural alignment measurements ( navicular drop and Q angle ) . Results Risk factors for the development of patellofemoral pain syndrome included decreased knee flexion angle , decreased vertical ground-reaction force , and increased hip internal rotation angle during the jump-l and ing task . Additionally , decreased quadriceps and hamstring strength , increased hip external rotator strength , and increased navicular drop were risk factors for the development of patellofemoral pain syndrome . Conclusion Multiple modifiable risk factors for patellofemoral pain syndrome pain have been identified in this investigation . To decrease the incidence of this chronic injury , the risk factors for patellofemoral pain syndrome need to be targeted in injury prevention programs . Clinical Relevance Prevention programs should focus on increasing strength of the lower extremity musculature along with instructing proper mechanics during dynamic movements to decrease the incidence of patellofemoral pain syndrome High levels of pain , significant anxiety , or depressive symptoms before surgery put patients at elevated risk for chronic pain and prolonged opioid use following surgery . The purpose of this preliminary study was to assess the efficacy of a 1-day Acceptance and Commitment Therapy ( ACT ) workshop in " at-risk " veterans for the prevention of  chronic pain and opioid use following orthopedic surgery . In a r and omized controlled trial , 88 at-risk veterans undergoing orthopedic surgery were assigned to treatment as usual ( TAU ; n = 44 ) or TAU plus a 1-day ACT workshop ( n = 44 ) . Pain levels and opioid use were assessed up to 3 months following surgery . Pain acceptance and values-based behavior were assessed at baseline and 3-month follow-up . Participants who completed the ACT workshop reached pain and opioid cessation sooner than those in TAU .  Postoperative complications exhibited a moderating effect on these outcomes , such that the effects of ACT were greater in patients without complications . Increases in pain acceptance and values-based behavior , processes targeted in ACT , were related to better outcomes . These promising results merit further investigation in a larger clinical trial . Providing an intervention before surgery for at-risk veterans has the potential to change clinical practice from a focus on management of postoperative pain to prevention of chronic pain in at-risk individuals . PERSPECTIVE This pilot study compared the effects of a 1-day preventive behavioral intervention ( ACT ) to TAU in at-risk veterans undergoing orthopedic surgery . Three months following the intervention , veterans receiving ACT exhibited quicker cessation of pain and opioid use . Focusing on preoperative pain management may help prevent chronic postsurgical pain Study Design . A follow‐up study of a cohort of 444 patients aged 16 to 59 years who consulted with their general practitioners(GPs ) in 1987‐1988 for an incident episode of back pain . Objectives . To determine the proportion of patients with back pain in whom chronic back problems develop after a follow‐up of 7 years , to compare health outcomes and labor force participation of patients with and without chronic back problems and to identify determinants of chronicity . Summary of Background Data . The incidence and prevalence of back pain are very high . A large proportion of the costs related to medical consumption , absence from work , and disability are probably caused by chronic back problems . It is unknown what proportion of back problems become chronic , especially after a long follow‐up period , and which factors can predict chronicity . Methods . Data on the course of the symptoms and medical consumption from the period between 1987‐1988 and 1991 were gathered retrospectively . Data on several health outcomes , including LFP , and data on some work characteristics were collected prospect ively in 1991 . A more extensive data set on health outcomes including psychologic status and working situation was collected in 1994 . Results . Chronic back problems developed in 28 % of the patients . These patients reported more pain , higher levels of medical re source consumption , worse health outcomes , and lower labor force participation . Episodes of back pain before 1987‐1988 , severe pain in 1991 , and disability score in 1991 were positively associated with chronicity in 1994 , difficulties with job performance in 1991 , and frequent stooping in the subgroup of patients who held a paying job in the follow‐up period . Conclusions . Even after a follow‐up of 7 years , the proportion of people with chronic back problems was high . The consequences for quality of life , labor force participation , and consumption of medical re sources are clear . Further research is necessary to examine determinants and ways to prevent chronicity UNLABELLED Although previous research suggests that preamputation pain is a risk factor for pain after amputation , little is known about the association between acute postsurgical pain and chronic amputation-related pain . The current prospect i ve study examined the associations of preamputation pain and acute postamputation pain with chronic amputation-related pain . The sample consisted of patients with lower limb amputation ( N = 57 ) who provided both preamputation and postamputation data during a 2-year study period .  Preamputation pain intensity and duration  were assessed before  amputation ; acute phantom limb pain ( PLP ) and residual limb pain ( RLP ) intensity were assessed on postsurgical days 4 and 5 . Acute PLP intensity was the only significant independent predictor of chronic PLP intensity at 6 and 12 months after amputation , whereas preamputation pain intensity was the only significant predictor of chronic PLP intensity at 24 months . Similarly , acute RLP was found to be the best overall predictor of chronic RLP . Other variables ( age , gender , level and etiology of amputation , amount of postsurgical pain medication , and duration of preamputation pain ) were not associated with chronic pain . These results suggest that higher levels of pain either before or soon after amputation might help to identify individuals at greatest risk for chronic pain problems and most in need of early , intensive pain interventions . PERSPECTIVE This study suggests that both preamputation pain and acute pain soon after amputation might be associated with bothersome chronic pain . The results support further research on acute pain mechanisms and the effectiveness of early interventions aim ed at preventing or managing amputation-related pain
Such interventions would have the potential to reduce the prevalence of chronic pain in the population .
Although certain risk factors can identify individuals who are most likely to develop chronic pain , few interventions to prevent chronic pain have been identified .
To facilitate the identification of preventive interventions , an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain .
We present general design considerations for prevention trials in population s that are at relatively high risk for developing chronic pain .