The Business Case for Preconception Care : Methods and Issues Only a limited number of economic evaluations have addressed the costs and benefits of preconception care . In order to persuade health care providers , payers , or purchasers to become actively involved in promoting preconception care , it is important to demonstrate the value of doing so through development of a `` business case '' . Perceived benefits in terms of organizational reputation and market share can be influential in forming a business case . In addition , it is standard to include an economic analysis of financial costs and benefits from the perspective of the provider practice , payer , or purchaser in a business case . The methods , data needs , and other issues involved with preparing an economic analysis of the likely financial return on investment in preconception care are presented here . This is accompanied by a review or case study of economic evaluations of preconception care for women with recognized diabetes . Although the data are not sufficient to draw firm conclusions , there are indications that such care may yield positive financial benefits to health care organizations through reduction in maternal and infant hospitalizations . More work is needed to establish how costs and economic benefits are distributed among different types of organizations . Also , the optimum methods of delivering preconception care for women with diabetes need to be evaluated . Similar assessments should also be conducted for other forms of preconception care , including comprehensive care . Introduction The opportunity to assist a woman before she becomes pregnant to improve her chances of a healthy pregnancy is compelling . Adverse pregnancy outcomes , including birth defects , preterm birth , and perinatal complications , are the leading causes of infant mortality in the United States -LSB- 1 -RSB- . Further , developmental disabilities such as cerebral palsy result in direct and indirect economic costs that can exceed $ 1 million over a given child 's lifetime -LSB- 2 -RSB- , in addition to the social and emotional costs incurred by families . A number of additional conditions are associated with serious complications of pregnancy , such as uncontrolled diabetes , hypothyroidism , hypertension , use of alcohol or tobacco , and obesity . The economic burden of most of these conditions in conjunction with pregnancy has been poorly studied but is likely to be enormous . This paper discusses the potential economic benefits of preconception care due to the prevention of adverse pregnancy outcomes with a focus on the data that would be needed to assess costs and benefits . Currently , the needed data and analyses are largely lacking . In the absence of information about the costs and benefits of comprehensive preconception care , which should ideally include nutritional counseling , evaluation of medications , and family history evaluation and genetic counseling , this paper focuses on principles and methods . Three published studies have analyzed the expected financial benefits from counseling women with diabetes prior to pregnancy . These studies are compared and lessons drawn , with discussion of implications of preconception care for women with other conditions . In order to argue that preconception care is a `` good buy , '' its costs and benefits must be assessed from the perspectives of a variety of stakeholders involved in health care services . This paper will first define a `` business case '' analysis and outline the methods for determining the `` return on investment '' from the perspective of various health care organizations . Similarities and differences between such an analysis and a standard cost-effectiveness analyses that calculate returns to the health care system as a whole or to society will be explained . Second , the paper reviews the literature on business case analyses from areas other than preconception care . Third , the paper discusses what data sources are available and needed to apply business case methods in preconception care with particular focus on women with diabetes . Finally , the paper draws conclusions about future steps needed to assess the business case for preconception care . What is a business case analysis ? Concepts and definitions A business case is an argument for a financial investment couched in terms of potential economic or market advantages to an organization , most commonly a private corporation -LSB- 3 -RSB- . The core of a business case is usually a budget impact analysis , a calculation of the financial return on investment -LRB- ROI -RRB- made by the firm -LRB- s -RRB- or organization -LRB- s -RRB- -LSB- 4 -RSB- . In addition to financial returns , such as cost savings or cost avoidance , a business case can be based on perceived strategic advantages such as enhanced organizational reputation , market positioning , or increased employee and customer satisfaction . This paper focuses just on financial business case analyses . According to the Institute for Healthcare Improvement -LRB- IHI -RRB- and the Commonwealth Fund -LSB- 3 -RSB- : A business case for a health care improvement intervention exists if the entity that invests in the intervention realizes a financial return on its investment in a reasonable time frame , using a reasonable rate of discounting . This may be realized as `` bankable dollars '' -LRB- profit -RRB- , a reduction in losses for a given program or population , or avoided costs . In addition , a business case may exist if the investing entity believes that a positive indirect effect on organizational function and sustainability will accrue within a reasonable time frame . A business case related to health care is based on one or several of the perspectives of specific payers , purchasers , or providers . Because health care providers , payers , and purchasers often have different , and sometimes conflicting , economic incentives , the business case for the same intervention will probably differ among these groups . For example , improved ambulatory care may lead to reduced inpatient admissions , which could result in financial savings for payers , lost revenue for hospitals , and higher costs for ambulatory care providers . The resulting misaligment of incentives in the health care system may , and often does , lead to inappropriate provision or use of certain services and underutilization of others -LSB- 3 -RSB- . Although business case analyses by definition focus on businesses , they are relevant to other stakeholders as well . In particular , the consumer perspective is also important to keep in mind . If consumers do not consider a service such as preconception care to provide good value for their investment of time and money , low demand and utilization could render the business case unfavorable . Further , government agencies must meet budgets , and the short term financial impact of policy changes may influence funding decisions . In the long run , though , public health programs are expected to optimize population health subject to resource availability , which requires analysis of both short-term and long-term health outcomes and economic consequences . Analytical techniques and outcome measures Financial analyses that underlie a business case are variably referred to as budget impact and ROI analyses . It is important to situate such analyses in the context of two commonly used methods of economic evaluation , cost-effectiveness analysis -LRB- CEA -RRB- and cost-benefit analysis -LRB- CBA -RRB- -LSB- 5 -RSB- . A CEA calculates the net monetary cost per unit of health outcome achieved . Certain preventive services are both more effective than alternatives and less costly -LSB- 6 -RSB- . A CEA that yields evidence of net cost savings from the payer perspective could be used to frame a business case , but CEAs rarely report payer-specific costs . In a CBA , all outcomes are expressed in dollar values , and the summary measure is expressed as either a net economic benefit or benefit-cost ratio . For example , a CBA of prenatal care for undocumented immigrants in California estimated that public funding cost the state $ 58 million but saved $ 211 million in long-term costs of care , for a projected net benefit of $ 153 million and a benefit-cost ratio of 4.6:1 -LSB- 7 -RSB- . A financial analysis of a business case can be viewed as a CBA conducted from the perspective of an individual firm or organization . One important distinction between financial analyses and standard economic evaluations is that the latter are supposed to reflect the opportunity cost or value of resources from a societal perspective whereas a financial analysis considers the direct monetary or budgetary impact to a specific organization . The ROI metric is typically calculated as the ratio of dollars in increased revenue or decreased cost divided by investment cost , although this can also be expressed as net cost difference -LSB- 8 -RSB- . Various other metrics can be used in a financial analysis , such as payback period or internal rate of return . For example , a recent study estimated the number of years that could be required for employers to realize a positive net benefit from bariatric surgery for obese employees as a result of reduced medical costs -LRB- all of which were assumed to be paid by the employer -RRB- and loss of work time -LSB- 9 -RSB- . ROI analyses require payer-specific costs , which are rarely reported in standard CBA studies . Time horizon and discount rate Business case analyses generally employ a short time horizon ; for example , only changes in use and costs over a period of 2 to 3 years following an intervention are typically considered . This reduces the problem of enrollee or employee turnover . When individuals switch plans or employers , the return on investments in the long-term health of that individual made by the former health plan or employer will be realized by someone else . This can make financial returns to employers or health plans substantially lower than the economic benefits to society -LSB- 3 , 10 , 11 -RSB- . A payback period ranging from 5 years to 10 years -LSB- 9 -RSB- is not likely to be attractive to employers . In economic evaluations from the societal perspective , it is conventional to discount costs occurring in future years using a discount rate of 3 % , which reflects the social return on capital -LSB- 5 -RSB- . For a business case analysis employing a short time horizon , long-term future costs or benefits may not need to be counted or discounted . In the short run , when ROI analysis does employ discounting , the discount rate should reflect the opportunity cost of capital in the private sector or individual firm . Prospective and retrospective evaluations Financial and health economic analyses of an intervention can be performed before or after its implementation . A prospective analysis predicts the financial return for a new initiative or program before it begins . This presumes that there is reliable information about the effectiveness of the intervention and accurate historical cost and revenue data . Analysts construct a simulation model that projects likely costs , health outcomes , and benefits based on a set of assumptions . The benefits include anticipated savings in health care costs and , for analyses from the employer perspective , worker productivity -LSB- 12 , 13 -RSB- . A limitation of prospective analyses is that key assumptions may turn out to be unrealistic . For example , analyses in the 1980s and early 1990s projected cost savings to Medicaid programs from reductions in the number of low birth weight -LRB- LBW -RRB- births if prenatal care coverage were expanded -LRB- e.g. , -LSB- 14 -- 16 -RSB- -RRB- . In conjunction with effective political advocacy and policy changes , these arguments succeeded in more than doubling the number of pregnancies covered by Medicaid prenatal care between 1986 and 1991 . Despite this expansion , little or no reduction in LBW rates could be confirmed to have occurred among eligible population groups -LSB- 17 -RSB- . The lack of an observed effect may reflect deficiencies in the effectiveness of the routine prenatal care that was offered , as well as barriers to access , and does not rule out a protective effect of an optimal prenatal care protocol . Although prenatal care expansion had other health benefits and can easily be defended , the cost-saving argument appears in retrospect to have been overstated -LSB- 18 -RSB- . In the absence of information about intervention effectiveness , a hypothetical calculation can be made regarding the potential magnitude of benefits if an effective intervention were to exist . One way to make such a calculation is to take cost-of-illness estimates of the economic burden of diseases and project the potential cost reduction that might occur as a result of prevention . Only short-term costs , which can be much smaller in magnitude than the long-term costs included in cost-of-illness studies , are likely to be relevant to employers or payers -LSB- 19 -RSB- . For example , one group of investigators calculated that poor birth outcomes such as preterm birth cost employer-sponsored health plans $ 5.6 billion in 1990 and projected that prevention of 10 % of preterm births would lead to a cost savings of $ 560 million -LSB- 20 -RSB- . A retrospective or ex post analysis is based on observed costs and benefits . For example , a recent ex post CBA of folic acid fortification calculated that the economic returns were substantially greater , and the costs somewhat lower , than had been projected in previously published analyses conducted prior to fortification -LSB- 21 -RSB- . Although actual data can yield more reliable results , it is challenging to collect data on multiple outcomes . Furthermore , interactions among the outcomes or confounding of results from other sources can make it difficult to precisely estimate the impact of the initiative or program alone . Lessons from business case literature A number of business case studies of disease management and health promotion initiatives have been published -LSB- 8 , 22 , 23 -RSB- . However , there is a paucity of well-conducted analyses and studies that contain detailed data on intervention and outcome costs -LSB- 24 -RSB- . Readers of business case analyses should beware of publication bias -LSB- 22 -RSB- and `` wish bias '' leading to optimistic estimates of effectiveness and compliance with behavioral changes -LSB- 10 -RSB- . One group that developed seven business case studies for health care quality improvement initiatives , such as disease management , concluded that health care providers , payers , and purchasers can not predictably expect to reap positive financial returns from initiatives to improve health care quality within short time horizons -LSB- 3 -RSB- . In the majority of case studies , short-term financial returns to health plan entities were negative . Furthermore , returns to health care providers were almost uniformly negative , as any cost savings were generally recouped by purchasers , and not by providers . In several cases , managers felt that there was a business case for investing in improved quality based on organizational benefits such as `` retained market share , increased staff loyalty , and reputation among employers '' rather than cost savings -LSB- 3 -RSB- . Similarly , the Child Health Business Case Working Group developed a set of business case studies -LSB- 25 -RSB- . For example , a case study of postpartum screening for risk factors in new mothers -LRB- e.g. , depression , smoking , domestic violence -RRB- followed by referral to community resources found that such a program would lead to higher costs for the practice without additional reimbursements . A positive business case for providers may require a financial mechanism for tying reimbursements by payers to improved outcomes -LSB- 3 -RSB- . Integrated health service providers under capitation payments may have more opportunity to internalize the financial gains resulting from improved care -LSB- 3 , 25 -RSB- . Several studies reported positive financial returns to managed care organizations -LRB- MCOs -RRB- from prenatal or perinatal interventions targeted to high-risk pregnant women -LSB- 26 -- 29 -RSB- , although these reports require validation and replication in well-controlled studies . For example , a high-risk pregnancy management program in upstate New York implemented by a managed care program serving Medicaid and other lower-income beneficiaries reported that cost savings from reduced NICU -LRB- neonatal intensive care unit -RRB- admissions were more than twice as great as the costs of the intervention -LSB- 28 -RSB- . A similar program implemented in another upstate New York MCO during the same time period reported investment costs -LRB- including provider reimbursements -RRB- of $ 573,355 , cost savings of $ 789,621 resulting from the estimated prevention of 48 LBW births , and a net benefit of $ 216,266 -LSB- 27 -RSB- . The authors reported an internal rate of return of 37 % on the investment , which is equivalent to an ROI ratio of 1.37 . Economic analyses of preconception care Finally , we turn to the application of business case methods to preconception care . Preconception care refers to three types of services and target populations : Preventive services and screenings offered to women who expect to become pregnant in the near future ; Interconception care for women who have given birth and intend to bear another child at some point in the future ; Counseling about the impact of pre-existing health risks or conditions for affected women of childbearing age and their impact on pregnancy outcomes . Few economic evaluations of individual screenings or services in the pre-pregnancy period have been published . One CEA estimated that promoting folic acid supplementation to all women of reproductive age would be cost effective , although not cost saving -LSB- 30 -RSB- . If multivitamins containing folic acid were targeted instead to women intending pregnancy , supplementation might be cost saving . On the other hand , because most of the averted costs of caring for children with spina bifida occur years in the future and are shared by multiple payers , this type of analysis can not be used to calculate the business case for folic acid supplementation strategies . One preconception care service with published analyses of short-term financial costs and benefits is preconception counseling for women with diabetes . Women with poorly controlled diabetes before pregnancy have an elevated risk of having an infant with a birth defect -LSB- 31 -RSB- , fetal death , or macrosomia . Women with poorly controlled diabetes prior to pregnancy can also experience medical risks during pregnancy , including diabetic retinopathy , nephropathy , and ketoacidosis , as well as pregnancy-induced hypertension and uteroplacental insufficiency -LSB- 32 -RSB- . A substantial body of evidence on infant health outcomes associated with preconception counseling for women with diabetes yields consistent findings . According to a meta-analysis of 14 epidemiologic studies , pregnancies preceded by preconception care result in one third as many major congenital malformations as pregnancies not preceded by preconception care -LSB- 31 -RSB- . The Maine Diabetes in Pregnancy Program found 4-fold lower rates of both congenital anomalies and fetal and neonatal deaths among pregnancies with preconception care -LSB- 33 -RSB- . More recently , the Diabetes Complications Control Trial -LRB- DCCT -RRB- of 1441 adults with Type 1 diabetes randomly assigned to conventional or intensive therapy , including 180 women who became pregnant , reported 8 congenital malformations in the conventional therapy group and only 1 in the intensive therapy group -LSB- 34 -RSB- . Thus , in the case of maternal diabetes , randomized trial data confirm the findings of numerous observational studies that control of diabetes prior to pregnancy results in dramatically fewer birth defects . Three economic evaluations of preconception and pregnancy care programs for women with non-gestational diabetes were identified in the published literature -LSB- 35 -- 37 -RSB- . All reported calculations of net short-term economic benefit based on reduced costs of maternal and neonatal hospitalizations and did not take into account long-term averted costs of care associated with the prevention of birth defects . Although the analyses were not developed as business case analyses , the focus on short-term costs and benefits is consistent with that approach . Regrettably , the lack of common metrics of cost and health outcomes makes it difficult to make direct comparisons of assumptions and findings of the three studies . The first study is a prospective analysis of a hypothetical program of comprehensive preconception diabetes care consisting of 20 visits prior to prenatal care -LSB- 35 -RSB- . The preconception visits were projected to cost $ 2,638 per enrollee in 1989 dollars . The investigators calculated that reduced maternal and infant hospitalizations would result in net benefits of $ 1,720 per enrollee . The majority of the hospitalization cost savings were projected to result from an 8-fold reduction in major congenital malformations , from 3.2 to 0.4 % . Using the cost of the intervention as the denominator , the benefit-cost ratio from the health care system perspective can be calculated to be 1.6 . This means that , on average , for every $ 1 spent on the program , reduced hospitalization costs of $ 1.60 would be expected . Although the projected percentage reduction in major malformations appears high relative to the literature , the projected intervention cost was also rather high , since it is uncertain that 20 visits would be needed for preconception care for women with diabetes . The second study , a retrospective analysis of data for the years 1986 -- 1988 from the California Diabetes and Pregnancy Program -LRB- CDAPP -RRB- , found that matched perinatal hospital charges for mother and child were 41 % higher for controls than for program participants -LSB- 36 -RSB- . The benefit-cost ratio was 5.19 , with reduced maternal and infant hospitalization costs of $ 5.19 observed for each $ 1 spent on the program . This finding likely contributed to the ongoing funding of the CDAPP . It is difficult to apply these findings to preconception care , though . Only 24 of 102 participants were enrolled in the program prior to 8 weeks of gestation , the time during which major congenital malformations are likely to occur . Although those participants had average charges that were 44 % lower than those who enrolled after 8 weeks , women who enrolled in the program prior to conception incurred higher costs per delivery because of the longer time during which services were received and the fact that not all women who enrolled became pregnant . Therefore , positive net financial returns to the component of preconception care were not demonstrated in that study . The third study is a retrospective evaluation of prospectively gathered data on pregnancy-related costs among women with type 1 diabetes who received both preconception care and prenatal care or prenatal care only at selected Michigan hospitals -LSB- 37 -RSB- . Women in the preconception care group received an additional two outpatient visits on average , at an added cost of $ 132 . The rate of congenital malformation was 4.2 % in the preconception care group compared with 13.5 % in the prenatal care-only group , a reduction of 69 % . The rate of maternal and neonatal intensive care unit -LRB- NICU -RRB- hospitalizations was 50 % lower in the preconception care group . Combining maternal and child hospitalizations , cost savings averaged $ 34,000 per woman enrolled in both preconception and prenatal care compared to those who received standard prenatal care . Although no information was presented on the distribution of costs in this study , an implication of the findings is that an integrated health plan could likely achieve cost savings by paying for a modest number of preconception care visits for women with type 1 diabetes . Discussion The economic and business case literature on preconception care is quite limited . There is some evidence of positive financial returns for preconception counseling for women with diabetes , based on savings in hospitalization costs -LSB- 35 -- 37 -RSB- . Although none of the studies involved randomized assignment , the relative differences in frequencies of birth defects are consistent with findings from other studies and increase the confidence that can be placed in the estimates of cost reductions . None of the studies indicate who was expected to bear the costs of counseling or the magnitude of cost savings to specific stakeholders . The studies are all based on relatively old data ; newer studies with more complete accounting of costs would be more informative . Furthermore , determination of the optimal number and cost of preconception visits is essential . The American Diabetes Association -LSB- 38 -RSB- and the American College of Obstetricians and Gynecologists -LSB- 39 -RSB- recommend that all women of childbearing age with diabetes receive counseling about the importance of glucose control before becoming pregnant . Despite these guidelines and positive economic analyses , many women with diabetes still do not receive such advice . A recent survey of women with diabetes ages 18 to 45 years enrolled in managed care plans found that only about half recalled receiving advice about the need for glucose control prior to pregnancy -LSB- 40 -RSB- . Research is needed to determine why some women with diabetes seek out preconception care and adopt intensive glucose control measures and others do not -LSB- 41 -RSB- . Potential barriers , such as opportunity cost of time , financial cost -LRB- e.g. , co-pays -RRB- , invasive testing , and medical risks -LSB- 32 -RSB- need to be analyzed from the consumer perspective . For example , it has been estimated that for patients with type 2 diabetes controlled by oral agents , following all self-care practices recommended by the American Diabetes Association could require more than 2 hours daily -LSB- 42 -RSB- . Better data are needed to establish the business case for preconception care . Although benefits of preconception care can be projected , data derived from the evaluation of actual preconception care initiatives are needed to make a compelling business case . Further , observational data comparing pregnancy outcomes among women who choose to use preconception care and those who do not are subject to biases due to non-randomized study design . A business case analysis of interventions with both demonstrated efficacy -LRB- works if followed -RRB- and effectiveness -LRB- behaviors are actually changed and lead to improved outcomes -RRB- is likely to be more persuasive . In order to develop a compelling business case for preconception care , studies of preconception care interventions accompanied by rigorous evaluations with randomized or matched groups of controls are required . Preparing a business case analysis based on intervention data poses challenges . It is logistically difficult but essential to prospectively collect data on costs and outcomes : `` To understand which quality-enhancing interventions are likely to produce positive returns on investments , data collection and analysis must include tracking the investment and operating costs of implementing the intervention as well as the changes in revenues and costs that result from the intervention '' -LSB- 24 -RSB- . Easily accessible or extant data sets typically do not allow one to calculate costs from the perspective of an individual organization . This requires quantifying actual reimbursements , co-pays , deductibles , etc. , rather than using standard charges for a clinic visit . It also requires tracking which patients are covered by different health plans and patterns of enrollment and disenrollment . Conclusion and the way forward Research demonstrating the effectiveness and financial returns to investments in preconception care is necessary to make a financial business case for preconception care . In particular , the only economic evaluations that have been published to date have been of specific components of preconception care , such as counseling women with diabetes or promoting preconception use of folic acid supplements . Evaluations of the costs and benefits of different `` bundles '' of preconception care services or comprehensive preconception care are needed . Further , such evaluations must include payer-specific cost data to be relevant to framing the business case for preconception care . Although more data are needed , such analyses may not be sufficient to ensure access to or provision of preconception care , as the diabetes preconception care experience suggests . Promotion of preconception care through carefully researched health marketing campaigns is also critical -LSB- 41 -RSB- . If , as a result of effective health marketing , consumers were to demand preconception care , providers and payers would be more likely to perceive a business case for providing it . Similarly , a business case might also be supported if health care professionals working with women of childbearing age were to advocate that their own organizations provide such services . Health care providers often lack the incentive to adopt a new service that improves outcomes ; therefore , particular attention must be paid to the structure of incentives by both public and private payers and purchasers -LSB- 3 -RSB- . Public health programs should fund studies evaluating the effectiveness of preconception care and develop marketing strategies to promote awareness of strategies that are proven effective . Studies that test and evaluate preconception care strategies should collect the financial data needed to conduct business case analyses -LSB- 24 -RSB- . Controlled evaluations of preconception care need to be accompanied by financial analyses to help make the business case for providing and paying for such services . Better quality evidence of both the financial and health costs of poor pregnancy outcomes and the benefits from preconception and early prenatal care is needed to provide a compelling business case .

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O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O 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O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O B I O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O

economic evaluation
prenatal care
diabetes in pregnancy
birth defects


Effects of Ambulant Myofeedback Training and Ergonomic Counselling in Female Computer Workers with Work-Related Neck-Shoulder Complaints : A Randomized Controlled Trial Objective : To investigate the effects of ambulant myofeedback training including ergonomic counselling -LRB- Mfb -RRB- and ergonomic counselling alone -LRB- EC -RRB- , on work-related neck-shoulder pain and disability . Methods : Seventy-nine female computer workers reporting neck-shoulder complaints were randomly assigned to Mfb or EC and received four weeks of intervention . Pain intensity in neck , shoulders , and upper back , and pain disability , were measured at baseline , immediately after intervention , and at three and six months follow-up . Results : Pain intensity and disability had significantly decreased immediately after four weeks Mfb or EC , and the effects remained at follow up . No differences were observed between the Mfb and EC group for outcome and subjects in both intervention groups showed comparable chances for improvement in pain intensity and disability . Conclusions : Pain intensity and disability significantly reduced after both interventions and this effect remained at follow-up . No differences were observed between the two intervention groups . Introduction Work-related musculoskeletal complaints in the upper extremity are common among workers in Western industrialised countries . In the Netherlands , about 15 % of the working population report complaints in the neck , shoulders and arms -LSB- 1 -RSB- defined as pain , numbness , or tingling , resulting in loss of productivity , sick-leave or even disability . In 1998 , about 8 % of all Dutch employees were absent from work due to work-related musculoskeletal complaints , and 2 % of the employee population was absent from work for more than four weeks -LSB- 2 -RSB- . These complaints impose a substantial economic burden in compensation costs , lost wages , and productivity . Apart from the individual suffering , the financial costs within member states of the European Union associated with musculoskeletal complaints are high -LSB- 3 -RSB- . Work-related musculoskeletal complaints are multifactorial in origin and involve biomechanical , psychosocial , and individual components -LSB- 4 -- 6 -RSB- . As a consequence different intervention approaches exist . Most often interventions address alterations of the physical work environment by adjustments of the work station and/or education about working posture according to ergonomic principles -LSB- 7 -- 10 -RSB- . There are several studies reporting on the effectiveness of ergonomic approaches -LSB- 11 , 12 -RSB- and it is commonly accepted that properly designed work stations are prerequisites for healthy working . However , in spite of attention to ergonomics musculoskeletal complaints remain a considerable problem -LSB- 13 -- 15 -RSB- and this is the rationale for the search for innovative interventions . A relatively new intervention approach addressing neck-shoulder complaints is myofeedback training based on the Cinderella-hypothesis -LSB- 16 -RSB- . The Cinderella-hypothesis is one of the most influential hypotheses explaining the process of development and persistence of pain in low intensity jobs -LSB- 17 -RSB- like computer work , and states that lack of sufficient muscle relaxation is a crucial factor in this process . Continuous muscle activity , even at low intensity levels , may result in homeostatic disturbances of the activated motor units due to affected blood flow and removal of metabolites -LSB- 17 -RSB- . Several studies have found an association between absence of moments of complete muscle rest and myalgia , especially for the commonly affected descending part of the trapezius muscle -LRB- e.g. -LSB- 18 -- 20 -RSB- -RRB- . Warning subjects when their muscle relaxation is insufficient could thus contribute to recovery , and this is the rationale for the Cinderella-based myofeedback training . This approach is different from traditional myofeedback training in which feedback is provided when muscle activity exceeds a certain level thereby aiming at decreasing muscle activation -LRB- e.g. -LSB- 21 , 22 -RSB- -RRB- . As the Cinderella-hypothesis suggests however that muscle relaxation is more relevant than muscle activation , a myofeedback-based intervention aiming at increasing muscle relaxation may be more beneficial . The Cinderella-based myofeedback system -LSB- 23 -RSB- consists of a harness incorporating dry surface electrodes and a feedback unit . The system is ambulant and subjects can wear the harness under their clothes during working days . The harness is connected to a feedback unit worn at the waist which provides feedback by means of vibration and a soft sound when muscle relaxation is insufficient . A feasibility study using this equipment for four weeks in a group reporting work-related neck-shoulder complaints resulted in significantly decreased levels of pain intensity and also changed muscle activation patterns . These effects were still at hand four weeks after the myofeedback training ended -LSB- 23 -RSB- . However , as the study did not contain a control group and only investigated the lasting effects of the intervention for a short follow-up period -LRB- 4 weeks -RRB- , further research is needed . As proper ergonomics are indispensable for healthy working , the myofeedback training is preferably applied in combination with an intervention approach aimed at improving ergonomics . Thus , the present study aimed at investigating the immediate and lasting effects of Cinderella-based myofeedback training including ergonomic counselling , compared to ergonomic counselling alone , on pain intensity and disability in females with work-related neck-shoulder complaints . As interventions focusing on multiple factors have shown to be related to decreased incidence of complaints -LSB- 24 -RSB- it was hypothesised that 4-weeks myofeedback training including ergonomic counselling would be more effective in reducing pain intensity and disability than the intervention based on ergonomic counselling alone . Methods and materials Design and subjects A randomized controlled trial was performed to assess the effect of 4-weeks Cinderella-based myofeedback training combined with ergonomic counselling -LRB- together referred to as Mfb -RRB- , compared to ergonomic counselling alone -LRB- EC -RRB- , on pain intensity and disability . Measurements were performed prior to intervention but before randomisation -LRB- Baseline -RRB- , immediately after four weeks of intervention -LRB- T0 -RRB- , and at three -LRB- T3 -RRB- and six -LRB- T6 -RRB- months after the intervention . Participants were recruited in Sweden -LRB- area of Göteborg -RRB- and the Netherlands -LRB- area of Enschede -RRB- between March 2003 and June 2005 . Computer workers like job counselors -LRB- Sweden -RRB- and -LRB- medical -RRB- secretaries -LRB- Sweden and the Netherlands -RRB- were approached by telephone and announcements , and volunteers were subsequently sent a screening questionnaire -LSB- 25 -RSB- which was developed within the EU-funded NEW project -LRB- Neuromuscular assessment in the Elderly Worker -RRB- -LSB- 26 -RSB- . Subjects eligible for participation were symptomatic female computer workers , predominantly over the age of 45 as the prevalence of complaints is especially high in this age category -LSB- 27 -RSB- , working for at least 20 hours a week , and reporting perpetuating work-related musculoskeletal complaints in the neck and/or shoulder region for at least 30 days during the last year . Subjects were excluded when they reported pain in more than 3 body regions , when they suffered from severe arthrosis or joint disorders , when they were using muscle relaxants , or when reporting other complaints in the upper extremity not related to -LRB- computer -RRB- work . Power calculation , based on the results of Hermens and Hutten -LSB- 23 -RSB- , indicated that at least 35 subjects should be included in each intervention group -LRB- estimated proportion of subjects showing an effect on pain intensity was set at 0.6 in the Mfb group and 0.2 in the EC group ; 1 − β = 0.90 ; α = .05 -RRB- . Block randomization was used to assign subjects to either Mfb or EC : When a new group of subjects started the intervention , half of them were assigned to Mfb and half of them were assigned to EC . The study was approved by the local Medical Ethics Committees and all participants gave their informed consent prior to participation . Interventions The interventions were provided by three different therapists : One physiotherapist in Sweden and two health scientists in the Netherlands . They were thoroughly trained and practiced together prior to the start of the study to ensure that they would provide as identical interventions as possible . The character of the intervention made blinding of the therapists and the subjects to the intervention impractical . To prevent from information bias , subjects were informed that the aim of the current study was to compare the effects of two interventions and that there was no evidence favouring one of these interventions . Ergonomic counselling -LRB- EC -RRB- Subjects received four weeks of intervention during which they kept a diary of activities and pain intensity scores . During the four weeks period they were visited weekly by their therapist . The first visit comprised an ergonomic workplace investigation by means of the risk inventory of Huppes et al. -LSB- 28 -RSB- . This checklist contains questions to evaluate work tasks , working hours , work load , work station , and working methods . Based on the outcome , possible improvements were discussed with the subject . With regard to the work station , the focus was primarily on modifying the existing work station rather than providing new equipment . The remaining visits were used to further discuss the ergonomic aspects , the consequences of possible ergonomic adjustments etc. , according to a manual to guarantee a uniform intervention . Myofeedback -LRB- Mfb -RRB- Subjects randomized to the Mfb group received Cinderella-based myofeedback training on top of EC . A two-channel ambulant myofeedback system combined with a harness incorporating dry surface Electromyography -LRB- sEMG -RRB- electrodes to enable a stable recording of upper trapezius muscle activity was used . The harness was connected to a sEMG processing and storage device -LRB- see Picture 1 -RRB- . Picture 1 Myofeedback system : Harness and processing/storage unit The sEMG signal was amplified -LRB- 15 × -RRB- , band pass filtered between 30 and 250 Hz , sampled at 512 Hz , digitized -LRB- 22 bits ADC -RRB- , and smooth rectified with removal of the low frequency components . Embedded software provided the detection and calculation of muscle rest , expressed as the sEMG parameter Relative Rest Time , which was defined as the percentage of time in which Root Mean Square was below a threshold -LRB- 10 μV -RRB- for at least 0.12 s . This threshold was based on the noise level of the myofeedback system including mounted electrodes at the skin . Sensory feedback by means of vibration and a soft sound was provided after each 10 s interval when the relative duration of muscle relaxation in that particular interval was below 20 % . The choice for a 10 s interval was based on the results of Voerman et al. -LSB- 29 -RSB- , and the 20 % threshold was chosen based on the work of Hägg and Åström -LSB- 30 -RSB- . Subjects were instructed that they should respond to the feedback by relaxation , which could be reached by slightly depressing the shoulders , or by sitting down quietly with the eyes closed , the hands in the lap while breathing deeply . Another relaxation strategy subjects were instructed was to maximally elevate the shoulders for three seconds to build up muscle tension and then to let loose this tension . This relaxation was anticipated to contribute to recovery of the Cinderella motor units . When there was no adequate response to the feedback , i.e. relaxation , the duration of the feedback signal progressively increased . Immediately after Baseline , subjects assigned to the Mfb group were given the myofeedback device and they were explained the working mechanism and background of the myofeedback training . Subjects wore the system for four weeks , for at least eight hours a week -LRB- distributed over two hours a day and two days a week as a minimum -RRB- while performing their regular work . During the weekly visits the sEMG-data from last week were scrutinized and discussed to give the subject insight in their relaxation patterns and to identify possible situations of concern . This procedure was facilitated by means of the diary . Assessment of pain intensity and disability Pain intensity in the neck , shoulder -LRB- left and right -RRB- , and upper back at time of the measurement was assessed by means of four Visual Analogue Scales -LSB- 31 -RSB- . Subjects were instructed to rate their subjectively experienced level of pain intensity at that moment for each body region . The Visual Analogue Scale consists of a 10 cm horizontal line with ` no discomfort at all ' at the left and ` as much discomfort as possible ' at the right endpoints of the line . Psychometric properties of the Visual Analogue Scale have been shown to be sufficient -LSB- 32 -- 34 -RSB- . The level of subjectively experienced disability was assessed with the Pain Disability Index , a self-rating scale that measures the impact of pain on the abilities to participate in life activities -LSB- 35 -RSB- . The Pain Disability Index contains 7 items , one for each domain , i.e. -LRB- 1 -RRB- family and home responsibilities , -LRB- 2 -RRB- recreation -LRB- hobbies , sports , and leisure time activities -RRB- , -LRB- 3 -RRB- social activity -LRB- participation with friends and acquaintances -RRB- , -LRB- 4 -RRB- occupation -LRB- activities partly or directly related to working -RRB- , -LRB- 5 -RRB- sexual behavior -LRB- frequency and quality of sex life -RRB- , -LRB- 6 -RRB- self care -LRB- personal maintenance and independent daily living -RRB- , and -LRB- 7 -RRB- life-support activity -LRB- basic life-supporting behaviors -RRB- . Answers were provided on a categorical 11-points scale with ` not disabled ' and ` fully disabled ' at the extremes . In a chronic pain population , psychometric properties of the Pain Disability Index appeared to be sufficient -LSB- 36 -RSB- . Analysis Data inspection showed non-normal distributions for all of the variables , and data were therefore log transformed , enabling parametric analyses . Analyses were performed both on the group as well as the individual level . For each subject , VAS scores for the neck , left shoulder , right shoulder , and upper back were summed and averaged resulting in a combined neck-shoulder pain intensity score . Differences between the two interventions , i.e. Mfb and EC , for VAS and the Pain Disability Index were investigated using a linear mixed-model analysis technique for repeated measurements . The following variables were included in the model as fixed factors : Time of measurement -LRB- i.e. Baseline , T0 , T3 , and T6 -RRB- , intervention type -LRB- i.e. Mfb and EC -RRB- , and study group -LRB- i.e. Sweden and the Netherlands -RRB- , including two-way interactions . The factor study group comprises variance due to possible -LRB- socio -RRB- demographic differences as well as variance caused by the different therapists , organizations , and job characteristics in the two countries . The factor subject was included in the model as a random factor . Paired and independent samples t-tests were used for Post Hoc analysis . At the individual level the percentages of subjects improving and the odds for improvement in both intervention groups were investigated . First , individual differences were calculated between Baseline and T0 , Baseline and T3 , and Baseline and T6 for pain intensity in the neck-shoulder region -LRB- i.e. the averaged score on the VAS for neck , left and right shoulders , and upper back -RRB- and Pain Disability Index . These differences were then dichotomized into ` clinically relevant improvement ' or ` equal/deteriorated . ' For the Visual Analogue Scale the cut-off point for a clinically relevant improvement was defined at 13 mm which corresponds to the upper limit of the confidence interval of clinically relevant changes in Visual Analogue Scale scores in acute and non-acute pain patients as reported by Kelly in 2001 -LSB- 37 -RSB- . This cut-off point was also the result of the study of Todd -LSB- 34 -RSB- . Cut-off points for clinically significant changes in the Pain Disability Index scores have not been provided in literature . For a comparable measure , the Neck Disability Index which is a 10 items scale with 6 answering options resulting in scores varying from 0 to 50 , the cut-off point was set at 5 which is 10 % of the maximum score -LSB- 38 -RSB- . Using this as a starting point , a clinically relevant change was defined as a change of ≥ 10 % of the maximum score of 70 of the Pain Disability Index , i.e. ≥ 7 units of the Pain Disability Index score . Logistic regression analyses providing Odds Ratios were performed to investigate whether the two intervention groups differed in terms of chances for clinically relevant improvements in pain intensity and disability . Three different models were investigated : Model I represents the crude Odds Ratio describing only the relationship between intervention type and odds for improvement without adjustment for confounding factors . The factors study group and baseline pain intensity/baseline disability were assumed potentially confounding factors . To correct for these factors , two additional models were built as extensions of Model I : Model II incorporates study group as confounding factor , and Model III is an extension of Model II incorporating also the factor baseline pain intensity/baseline disability level . For Models II and III interaction effects were additionally included in the analysis , to study effect modification , but these remained only included when significant . − 2 Log Likelihood tests were used to select the best model . Odds Ratios including 95 % Confidence Intervals were calculated and presented for each of the models . Statistical Package for Social Sciences 11.5 was used for statistical testing and alpha was set at .05 for statistical significance . Results Subjects Seventy-nine female computer workers with neck-shoulder complaints were included in this study : Forty-two subjects were assigned to the Mfb group and 37 to the EC group . Mean age was 52.0 -LRB- SD 5.8 years -RRB- in the Mfb group and 50.7 -LRB- SD 5.5 -RRB- years in the EC group . Mean duration -LRB- days between Baseline and T0 -RRB- of the interventions was 37 -LRB- SD 8 -RRB- days for the Mfb group and 36 -LRB- SD 7 -RRB- days for the EC group . Forty-one out of the 79 subjects were recruited in Sweden and the remaining 38 in the Netherlands . The number of subjects at Baseline , T0 , T3 , and T6 and the number of drop-outs are shown in Diagram 1 . Diagram 1Flow chart subject recruitment and randomisation Drop-outs did not differ in age , weight , height , BMI , and pain intensity scores -LRB- Visual Analogue Scale -RRB- , and disability -LRB- Pain Disability Index -RRB- from those fulfilling the intervention -LRB- p > .08 -RRB- . Table 1 provides an overview of sociodemographic characteristics of the subjects in the Mfb and EC groups . Thirty-eight subjects reported complaints in both the neck and shoulder , while 41 subjects reported complaints either in the neck or in the shoulder at the time of recruitment . Comparison of the characteristics between the Mfb and EC groups indicated that subjects assigned to the Mfb group reported more years within the same job compared to the EC group -LRB- p < .05 -RRB- . Table 1Characteristics of subject populationMfb -LRB- n = 42 -RRB- EC -LRB- n = 37 -RRB- Sociodemographics Body mass index25 .2 -LRB- 3.9 -RRB- 25.2 -LRB- 3.7 -RRB- Side dominance % Right-handed95 % 97 % Living situation % Living alone16 .710.8 Working hours per week32 .8 -LRB- 7.8 -RRB- 32.8 -LRB- 8.3 -RRB- Working hours per week since -LRB- in years -RRB- 17.0 -LRB- 11.4 -RRB- * 12.0 -LRB- 8.9 -RRB- * Complaints Trouble in neck last yearYes92 .991.9 Trouble shoulders last yearYes , in both shoulders36 .632.4 Yes , in the right shoulder36 .643.2 Yes , in the left shoulder12 .213.5 Trouble in upper back last yearYes66 .748.6 Was work performance affectedYes31 .718.9 * Significant at the .05 level . Analysis at group level Pain intensity Baseline -LRB- geometric -RRB- mean VAS scores for each region separately were 27 mm -LRB- neck -RRB- , 15 mm -LRB- left shoulder -RRB- , 14 mm -LRB- right shoulder -RRB- , and 13 mm -LRB- upper back -RRB- in the Mfb group and 24 , 14 , 19 , and 18 mm in the EC group respectively . Figure 1 shows a box plot of the VAS score in the neck-shoulder region at Baseline , T0 , T3 , and T6 for the Mfb and the EC group . A clear decrease was observed at T0 , T3 , and T6 compared to Baseline , although at T6 pain intensity seemed to increase slightly in both groups.Fig . 1Box plot for averaged VAS score of pain intensity in the neck-shoulder region at Baseline , T0 , T3 , and T6 for both the Mfb and the EC group Mixed linear modelling showed that pain intensity in the neck-shoulder region significantly changed over time -LRB- F = 12.08 , p ≤ .01 -RRB- , without additional effects for the type of the intervention -LRB- F = 1.54 , p = 0.22 -RRB- , study group -LRB- F = .48 , p = .49 -RRB- , or interaction effects -LRB- F ≤ .87 , p ≥ .35 -RRB- . Post Hoc comparisons revealed that the VAS score was significantly reduced at T0 -LRB- t = 4.37 , p < .01 -RRB- , T3 -LRB- t = 5.10 , p < .01 -RRB- , and T6 -LRB- t = 3.54 , p < .01 -RRB- compared to Baseline but also the reduction between T0 and T3 was significant -LRB- t = 2.85 , p = .01 -RRB- . Disability Figure 2 shows a box plot of the Pain Disability Index score at Baseline , T0 , T3 , and T6 for the Mfb and the EC group . A comparable pattern to what was observed for pain intensity was found , with decreased disability levels at T0 , T3 , and T6 compared to Baseline.Fig . 2Box plot for the Pain Disability Index score at Baseline , T0 , T3 , and T6 for both the Mfb and the EC group Disability levels significantly changed over time -LRB- F = 17.68 , p < .01 -RRB- and were significantly different between the two study groups -LRB- i.e. Sweden and the Netherlands -RRB- -LRB- F = 5.30 , p = .02 -RRB- . No additional effects were found for intervention type -LRB- F = .86 , p = .35 -RRB- nor the interaction terms -LRB- F ≤ 1.97 , p ≥ .12 -RRB- . Post Hoc comparisons showed that subjects in the Swedish study group had lower Baseline values and reported reductions in disability only between Baseline and T0 -LRB- t = 2.20 , p = .04 -RRB- with a trend for reductions at T3 -LRB- t = 1.89 , p = .07 -RRB- and T6 -LRB- t = 1.81 , p = .08 -RRB- . Subjects in the Dutch study group showed a significant decrease at T0 -LRB- t = 3.26 , p < .01 -RRB- , T3 -LRB- t = 3.58 , p < .01 -RRB- , and T6 -LRB- t = 3.51 , p < .01 -RRB- compared to Baseline . Analysis at the individual level Pain intensity Figure 3 gives an overview of the percentage of subjects in the Mfb and EC groups showing an improvement in pain intensity in the neck-shoulder region . About half of the subjects showed a clinically relevant improvement in pain intensity in the neck-shoulder region . Slightly more subjects in the Mfb group showed improvements compared to the subjects in the EC group immediately after the intervention period -LRB- T0 -RRB- and at 6 months follow-up -LRB- T6 -RRB- . Fig. 3Percentage of subjects showing improvements in averaged VAS score of pain intensity in the neck-shoulder region at T0 , T3 , and T6 compared to Baseline for the Mfb and EC group -LSB- without correcting for confounding factors -RSB- Crude Odds Ratios -LRB- Model I -RRB- for improvement showed higher odds for clinically relevant improvement in the Mfb group at T0 and T6 compared to Baseline , while between T3 and Baseline subjects assigned to EC were more likely to show improvements -LRB- see Table 2 -RRB- . However , Odds Ratios were not significant -LRB- p ≥ .36 -RRB- also not when corrected for potential confounding factors -LRB- p > .19 -RRB- . − 2 Log Likelihood tests indicated that Model III , adjusting for the factors study group and baseline pain intensity/disability level , superimposed the Models I and II -LRB- − 2 LL ; p < .05 -RRB- . As no significant interaction effects were found -LRB- p > .08 -RRB- these were excluded from the final models as presented in Table 2 . Table 2 -LRB- Adjusted -RRB- odds ratios -LRB- 95 % confidence interval -RRB- for improvement in pain intensity in the neck-shoulder region for the Mfb group compared to the EC groupModel IModel IIModel IIIVAS1 .561.593.42 Baseline -- T0 -LRB- .60 -- 4.05 -RRB- -LRB- .71 -- 4.14 -RRB- -LRB- .55 -- 21.11 -RRB- VAS .78.78.40 Baseline -- T3 -LRB- .29 -- 2.08 -RRB- -LRB- .29 -- 2.09 -RRB- -LRB- .08 -- 1.99 -RRB- VAS1 .311.311.04 Baseline -- T6 -LRB- .47 -- 3.60 -RRB- -LRB- .47 -- 3.64 -RRB- -LRB- .29 -- 3.77 -RRB- Model I : Odds Ratio Crude.Model II : Odds Ratio Adjusted for factor study group.Model III : Odds Ratio Adjusted for factor study group and VAS at Baseline . Disability An overview of the percentage of subjects in the Mfb and EC groups showing an improvement in disability is provided in Fig. 4 . Fig. 4Percentage of subjects showing clinically relevant improvements in Pain Disability Index at T0 , T3 , and T6 compared to Baseline for the Mfb and EC group -LSB- without correcting for confounding factors -RSB- Immediately after the intervention period about twice as many of the subjects in the Mfb group showed clinically relevant improvements in disability compared to the EC group . This share of subjects increased somewhat in both groups after three months and then showed a small decline after six months where about one third of the subjects of the EC group and half of the Mfb group showed clinically relevant improvements in disability . Subjects assigned to the Mfb group had higher odds for improvement in disability at T0 , T3 , and T6 : At T3 , the odds for improvement in disability was 2.77 times higher in the Mfb group compared to the EC group which was significant -LRB- Model I ; 95 % CI 1.00 -- 7.65 ; p = .05 -RRB- . When corrected for confounding variables , however , Odds Ratios for improvement were still higher for the Mfb group compared to the EC group , but this was not significant -LRB- p ≥ .057 -RRB- except for Model II for changes between Baseline and T3 -LRB- p = .04 -RRB- . Baseline disability levels significantly affected Odds Ratios : Model III was generally better than the models I and II -LRB- − 2 LL ; p < .05 -RRB- . As no significant interaction effects were found -LRB- p > .08 -RRB- these were excluded from the final models as presented in Table 3 . Table 3 -LRB- Adjusted -RRB- odds ratios -LRB- 95 % confidence interval -RRB- for improvement in disability the Mfb group compared to the EC groupModel IModel IIModel IIIPain disability index2 .702.721.48 Baseline -- T0 -LRB- .97 -- 7.54 -RRB- † -LRB- .971 -- 7.60 -RRB- † -LRB- .39 -- 5.62 -RRB- Pain disability index2 .772.991.64 Baseline -- T3 -LRB- 1.00 -- 7.65 -RRB- * -LRB- 1.03 -- 8.65 -RRB- * -LRB- .34 -- 7.97 -RRB- Pain disability index2 .542.611.48 Baseline -- T6 -LRB- .88 -- 6.82 -RRB- † -LRB- .91 -- 7.47 -RRB- -LRB- .37 -- 5.88 -RRB- Model I : Odds Ratio Crude.Model II : Odds Ratio Adjusted for factor study group.Model III : Odds Ratio Adjusted for factor study group and Pain Disability Index at Baseline . * p ≤ .05 . † .05 ≤ p ≤ .10 . Discussion This randomised controlled trial investigated the effects of 4-weeks ambulant myofeedback training combined with ergonomic counselling in subjects with work-related neck-shoulder complaints relative to ergonomic counselling alone , on pain intensity and disability . The effects were evaluated immediately after the interventions , and at three and six months follow-up . Mean pain intensity and disability levels significantly reduced after both interventions -LRB- i.e. Mfb and EC -RRB- . The effects were clinically relevant in a large part of the subjects : About 30 -- 50 % of the subjects showed clinically relevant improvements in pain intensity and/or disability . No difference was found for the effect of the intervention on outcome and after correction for confounding factors subjects in both intervention groups did not differ with regard to chances for clinically relevant improvements in pain intensity and disability . Several studies have shown the beneficial effect of myofeedback training on pain reduction -LSB- 21 , 39 -- 43 -RSB- although Faucett and colleagues -LSB- 22 -RSB- reported changes in muscle activity rather than changes in pain intensity . The feedback approach used in these studies is different from the Cinderella-based myofeedback approach in that the traditional feedback method provides feedback when muscle activation is too high -LSB- 21 , 22 , 42 , 44 -- 47 -RSB- , rather than when the time the muscle has relaxed is too short -LSB- 23 -RSB- . Two previous studies applying the Cinderella-based myofeedback training in subjects with work-related complaints -LSB- 23 -RSB- and subjects with a whiplash associated disorder -LSB- 48 -RSB- reported reduced pain intensity and disability levels . Compared to these studies , baseline pain intensity values were generally lower and the cut-off points for clinically relevant changes were set to higher levels in the current study , but the results indicate a comparable percentage of subjects reporting clinically significant reductions in pain intensity , i.e. between 35 and 50 % of the subjects . This consistency in results adds to evidence for the effectiveness of -LRB- Cinderella-based -RRB- myofeedback training on pain intensity and disability in musculoskeletal neck-shoulder complaints . In line with existing literature -LRB- e.g. -LSB- 8 , 10 , 49 , 50 -RSB- -RRB- also subjects in the ergonomic counselling group reported reduced pain intensity and disability . It was however hypothesised that a treatment approach including both myofeedback training and ergonomic counselling -LRB- Mfb -RRB- would be more effective than treatment comprising only ergonomic counselling -LRB- EC -RRB- as interventions focusing on multiple factors have shown to be related to decreased incidence of complaints -LSB- 24 -RSB- . In the current study the two types of interventions did not differ in terms of outcome . This is in line with findings of other studies -LRB- e.g. -LSB- 8 , 10 , 51 -- 53 -RSB- -RRB- that concluded that occupational interventions have generally comparable effects , although these studies did not include a myofeedback intervention . Newton-John and others -LSB- 43 -RSB- compared myofeedback with cognitive-behavioural therapy and a waiting list control group and found that both interventions showed favourable outcome in terms of pain intensity and disability compared to the waiting list control group without a difference between the two interventions . There are possible explanations for the absence of differences between the two groups . One concerns the presence of subgroups in which the intervention is beneficial . Results showed that the effect is clinically relevant in about 30 -- 50 % of the subjects . Main question to be addressed here is whether , and how , these subjects can be characterised in terms of cognitive-behavioural characteristics and whether this characterisation can contribute to predict outcome of the intervention . This could substantially improve the efficiency and effectiveness of the interventions . Further , differences between the two groups may have been masked by using rather generic outcome measures . For instance , coping and patient-rated parameters may better represent the difference in outcome between different kinds of interventions -LSB- 54 -RSB- . Investigation into the specific working mechanisms of both interventions could clarify this . Finally , initial VAS and disability levels were low in both the Mfb and the EC group , especially in the study group from Sweden . This results in a smaller potential for improvement -LRB- floor effect -RRB- and as a result a smaller chance for finding differences between the Mfb and EC groups . Methodological considerations This study did not include a non-intervention or placebo control group -LRB- for instance randomly administered feedback -RRB- which makes it hard to control for non-specific effects like regression to the mean or the Hawthorne effect -LSB- 55 -RSB- . This effect was already described in 1933 by Mayo , and is reported as a significant positive effect without causal basis in the theoretical motivation for the intervention , but is related to the effect on the participants knowing themselves to be studied in connection with the outcomes measured . An argument against such effect is that although it might occur in connection with the intervention -LRB- i.e. at T0 -RRB- it is not likely that this effect would remain -LSB- 56 -RSB- after three to six months . In addition , the study population also contained subjects with chronic complaints -LRB- i.e. duration > 6 months -RRB- who received a variety of treatments in the past , which were not successful . It is likely to expect that any non-specific effects of treatment would already have occurred during past treatments and that this effect in the current study would thus be small . Furthermore , results from previous studies learned that pain reduction in myofeedback-trained subjects were higher compared to a wait-list control group -LSB- 43 -RSB- , a no intervention group -LSB- 46 -RSB- , or subjects receiving a placebo -LSB- 57 -RSB- . Furthermore , an attention-only group showed no changed outcome in terms of disability and pain intensity -LSB- 58 -RSB- . The present study included a rather specific subject population : Participants were females , predominantly over the age of 45 , still at work , and characterised by relatively low pain intensity and disability levels . Interpretation and extrapolation of results to other populations therefore requires caution , but as comparable effects of Cinderella-based myofeedback training have also been shown in mixed , younger subject populations -LSB- 23 , 48 -RSB- and in a sample of patients who were on sick leave because of their neck-shoulder complaints -LSB- 48 -RSB- , generalisation of findings might be legitimate . The subjects were selected based on self-reported complaints rather than a clinical evaluation . In a previous study -LSB- 60 -RSB- with female computer users above the age of 45 , applying the same inclusion criteria as the present study , it was found that in subjects with neck-shoulder complaints the following clinical diagnoses were most prevalent : Trapezius myalgia -LRB- 38 % -RRB- , tension neck syndrome -LRB- 17 % -RRB- , and cervicalgia -LRB- 17 % -RRB- . These diagnoses were found in 60 % of the subjects reporting complaints . There were cases with supraspinatus tendinitis , frozen shoulder , and biceps tendinitis , but these were less common . This general pattern of clinical signs is likely to be at hand also in the present study . It could be hypothesised that myofeedback may be particularly relevant and helpful in cases with muscular pain syndromes . Despite extensive standardisations , the recruitment of subjects in two different study groups -LRB- Sweden and the Netherlands -RRB- resulted in heterogeneity of the subject population with regard to age , working hours , seniority , and working posture . To correct for this , the factor study group was considered a confounder needed to control for during analysis . This reduced the power of the study . An additional likely confounding factor is the compliance of the patient and therapist to the intervention . This is an often uncontrolled and thus potentially confounding factor in occupational intervention studies -LSB- 59 -RSB- and it is known that changes in knowledge and skills do not necessarily result in a behavioural change . In the Mfb group , the compliance was partly controlled as the number of hours the system was worn was recorded by the system itself , but the compliance to ergonomic knowledge and skills is hard to register objectively . This definitely is a challenge in future occupational intervention studies . The drop-out rate in the Mfb group was higher than in the EC group -LRB- i.e. nine compared to five -RRB- , which was probably related to the myofeedback system itself . Some subjects found the system inconvenient and disturbing in daily working activities . This may have suppressed the effect of the intervention . Improvement of the current device in terms of usability is therefore required to optimise the myofeedback training . Conclusions Four-weeks of intervention significantly reduced pain intensity and disability , and this effect remained after three and six months follow-up . Myofeedback training combined with ergonomic counselling is thus beneficial for female computer workers over the age of 45 , reporting pain and disability in the neck-shoulder region but no evidence was found favouring myofeedback training combined with ergonomic counselling over ergonomic counselling alone . Future research may aim at identifying possible subgroups of patients in which the interventions are especially beneficial . This may enhance the efficiency and the effectiveness of the interventions . Finally , as non-specific effects may have interfered with outcome , future studies could include a placebo control group for more insight in the specific effects of ambulant myofeedback training combined with ergonomic counselling .

O O O B I O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O 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O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O

work-related neck-shoulder complaints
neck-shoulder region