A self-management program for employees with complaints of the arm, neck, or shoulder (CANS): study protocol for a randomized controlled trial

Complaints of the arm, neck, or shoulder (CANS) are common among people who work [1]. The reported point prevalence varies from 1.6% to 53% and the 12-month prevalence varies from 2.3% to 41% depending on the setting, definition, and classification used [2–4]. CANS is persistent; 77% of employees with CANS still have complaints after 6 months [5]. Also, about 19% of the patients report chronic complaints of which 58% report the use of healthcare, such as care given by the general practitioner, medical specialist, and physical therapist [3]. At one Dutch university, 11% of the employees reported regular physical complaints due to working with the computer and 4% reported to have these complaints very often [6].

Although musculoskeletal disorders of the upper extremity and neck are common, there is no international consensus on related terminology [7]. Terms such as ‘complaints of the arm, neck, or shoulder’ [8], ‘work-related upper extremity musculoskeletal disorders’ [9], ‘musculoskeletal upper extremity disorders’ [10], ‘neck and upper extremity complaints’ [5], ‘work-related upper limb disorders’ [11], and ‘repetitive strain injuries’ [12] are all frequently used. However, in these classifications a distinction is usually made between specific CANS (such as epicondylitis, carpal tunnel syndrome) and non-specific CANS [8]. The most recent consensus statement in the Netherlands was published in 2007 [13]. This multidisciplinary consensus on terminology was reached among healthcare professionals and supports the diagnosis and classification of all CANS not caused by acute trauma or by any systemic disease [8]. Within these complaints, 23 disorders are classified specific, because they were judged as diagnosable disorders by experts. All other complaints are labeled non-specific [8]. Non-specific CANS is characterized by pain or tingling sensations located in the arms, shoulders, neck, or upper back without a clear pathophysiological substrate [14]. Many people suffering from CANS have complaints in more than one region [3, 5].

CANS causes major work problems, including presenteeism (decreased work productivity while at work), absenteeism (sickness absence), and, ultimately, job loss [1, 15]. In the Netherlands, CANS is responsible for about 15% of the total number of sick days [11]. The total yearly costs in the Netherlands of neck and upper limb symptoms due to decreased productivity, sick leave, chronic disability for work, and medical costs has been estimated in 2003 at 2.1 billion Euros [7]. Thus, work-related neck and upper limb symptoms have both a medical and a substantial socioeconomic impact [16]. The annual prevalence of sickness absence due to work-related upper-extremity complaints is reported to be 2% to 4% of the general workforce [17]. Sickness absenteeism and permanent disability are important components of decreased productivity, but they represent only a part of its total cost [1]. A considerable proportion of health-related productivity loss derives from presenteeism, that is, decreased work performance while at work [1, 18, 19]. This is endorsed by Van den Heuvel et al. [19] who found that in 26% of the cases reporting CANS, productivity loss was involved. Moreover, in 68% of all cases reporting productivity loss, this was due to decreased productivity at work, while the other 32% was due to sickness absence [19].

Although the exact etiology of non-specific CANS is unknown, it is reported to be of multifactorial origin [20–23]. Physical characteristics (that is, wrong working posture, repetitive work), psychosocial characteristics (that is, lack of social support from colleagues or superior), personal factors (that is, an ineffective approach to stress management) of the individual worker as well as characteristics of their work environment (that is, high job demands, lack of control), contribute to the development and persistence of complaints [5, 20–28]. The importance of each factor, and its individual contribution to the risk of provoking symptoms, varies among individuals and work environments [29].

Communication with supervisors to understand the needs and challenges of the employee is essential, and tailoring of an intervention to accommodate the employees’ needs is important [30]. Work-related factors (that is, high job strain) seem to be important determinants of perceived disability, especially among younger employees [1]. Favorable psychosocial work characteristics might prevent productivity loss in symptomatic employees with CANS [19]. Among office workers, an adverse work style increases the risk of having upper-extremity pain [29, 31]. Because work style consists of a combination of factors (for example, working through pain, handling deadlines/pressure, handling stress, and self-imposed workload) interventions could be developed to address each of these individually [29]. Pain intensity and its impact on work and sleep, psychosocial factors (that is, lack of social support of colleagues or superior, work pressure), as well as physical factors at work (that is, wrong working posture) should all be included as potential targets for interventions to improve the management of disability caused by CANS [1, 5, 32].

Despite the multifactorial origin of CANS, most intervention studies focused only on the physical components of the workplace [16]. There is limited evidence on the effectiveness of exercises when compared to massage; adding breaks during computer work; massage as add-on treatment to manual therapy, and manual therapy as add-on therapy to exercises [33]. There is conflicting evidence concerning the effectiveness of exercises over no treatment or as add-on treatment, and no differences were found between various kinds of exercises [33]. Also, there is conflicting evidence regarding the effectiveness of ergonomic interventions [9, 10, 33–36].

Nowadays, multi-component interventions that include both biomechanical and psychosocial components are recommended [9, 22, 37]. Bernaards et al. [38, 39] developed a workstyle intervention for computer workers, which focused on behavioral change with regard to body posture, workplace adjustment, breaks, and coping with high work demands. This intervention was effective in improving recovery from neck/shoulder symptoms and reducing pain in the long term (12 months) compared to usual care, whereas no effects were found after 6 months and in arm/wrist/hand pain [40].

There seems to be a need for intervention programs for people suffering from CANS [8, 31]. Among Dutch employees with sickness absence due to CANS, 24% believe that work is mainly the cause of their complaints and 30% stated that these complaints are partly caused by work [40]. Also, 19% of the Dutch employees stated that measures at work are needed in the area of CANS because these are either not, or insufficiently, available. Self-management is an approach increasingly used in chronic disease care to improve self-efficacy and wellness behaviors [41]. Barlow et al. [42] defined self-management as ‘the ability to manage the symptoms, treatment, physical and psychosocial consequences, and lifestyle changes inherent in living with a chronic condition’. Self-management programs aim to help participants make informed choices and then carry them out [43]. Key self-management skills include: problem-solving, decision-making, resource utilization, forming partnerships with healthcare providers, and taking action [43]. Program participants are up-skilled in personalized goal setting and action care planning. Collaborative problem definition is based on their readiness to change and self-efficacy [44]. Self-management interventions focus primarily on encouraging patients to be involved with and in control of their own treatment, as well as improving their understanding of how their condition and treatment affect their lives [45]. As a result, self-management interventions reflect a change from a patient passively receiving care to a collaborative model in which the patient and provider share their knowledge and work together to achieve a goal of optimal self-management [45].

There is inconsistent evidence for the effects of self-management programs for patients with chronic musculoskeletal pain [46–48], and there is some evidence that group-delivered short programs (<8 weeks) with a healthcare professional involved have the best potential [46]. A multi-component pain and stress self-management group intervention was found to have better effect than individually administered physical therapy in the treatment of persistent musculoskeletal tension-type neck pain regarding coping with pain, in terms of patients’ self-reported pain control, self-efficacy, disability, and catastrophizing pain, over the 20-week follow-up [49].

Many employees suffering from CANS still go to work despite the feeling that, in view of their health, they should have taken sick leave [19]. Thus, employees with CANS continue working, which often results in the persistence of their complaints. In a study of Van Eijsden et al. [20] nearly all employees suffering from CANS said that they were very precise persons, and incapable of dealing with heavy workload or tight deadlines. Moreover, employees explained that they had high work standards and would ignore the workload and onset of symptoms, despite knowing that these symptoms could become chronic in a few months [20]. Thus, it seems important that employees suffering from CANS make informed choices and carry them out so that they have the ability to manage the symptoms, healthcare utilization, physical and psychosocial consequences, and lifestyle changes inherent to living with CANS. Self-management programs addressing physical characteristics, psychosocial characteristics, and personal factors of the individual worker, as well as characteristics of their work environment, may be useful for employees suffering from CANS.

Detaille et al. [50, 51] developed a self-management program for employees in the Netherlands with a chronic disease. Following the process of intervention mapping [52, 53] we adapted their program to suit and alleviate the problems and needs of employees suffering from CANS.

We present a study which aims to evaluate the effectiveness of a self-management program (including ehealth) and compare this with usual care in employees suffering from chronic non-specific CANS (persisting >3 months) using an RCT design.

Based on a recent multidisciplinary guideline [36], relevant literature, focus group sessions with employees suffering from CANS, and relevant experts, we adapted a self-management program for employees with a chronic disease in the Netherlands developed by Detaille et al. [50] to suit and alleviate the problems and needs of employees with CANS. The strength of this intervention is that the program is specifically tailored to the needs of employees with CANS. Focus group sessions with employees identified the needs of participants related to disease-specific information, exercises, muscle relaxation, working with pain, work and social environment, and personal factors (including work style).

To meet these needs we will combine the adapted self-management program with an additional ehealth component, which provides the participants with valuable information related to CANS. Participants are also up-skilled in personalized goal-setting and action-planning, and collaborative problem definition is based on their readiness to change and their self-efficacy. By making action plans, we expect participants to take actions to manage their symptoms, treatment, physical and psychosocial consequences, and lifestyle changes inherent to living with CANS. Strengths of the study include the RCT design and the use of pre-stratification, which excludes the chance of possible confounding by indication.

The study also has some potential weaknesses. One of them is the differential use of co-interventions in the groups. At T3 we will monitor the use of co-interventions in both groups, so that we can use this information when drawing our conclusions. We will also ask the IG whether the intervention has contributed to the use of co-interventions. There is a small risk of contamination because (in theory) it is possible that two direct colleagues will participate, albeit allocated to different groups; however, we consider this a small chance, since the three organizations involved have large numbers of employees (200–9,000 employees). Another potential weakness is that the questionnaires used in this study will be provided digitally. Although questionnaires will be provided only four times during the entire study, for employees with CANS doing computer work this might represent an extra load. However, since the questionnaires can be completed while taking breaks, we believe that participants are likely to fill in all the questionnaires.

We adapted our intervention based on the needs of employees of two participating organizations (HAN UAS and RUNMC). Based on the literature, we assume that their experiences and needs are largely the same as that of employees working in other institutes or companies. Moreover, we also adapted our self-management program based on focus group sessions with experts and on the literature. Therefore, we expect the program to be suitable for the general population of employees suffering from CANS. We realize that our program will demand some time and effort from the participants and that employees usually have little time to spare. Therefore, potential participants must be sufficiently motivated.

Although one strength of the study might be the combination of a self-management program and ehealth, this also implies that if the intervention is effective we do not know to what extent each component has contributed to these effects. Therefore, in the quantitative evaluation at T3 as well as in the qualitative evaluation of the program (in-depth interviews), we will ask participants about their experiences and the usefulness of both components.

The internal validity of this RCT might be affected by the fact that blinding of the participants is not possible. A potential source of bias is the difference in the amount of attention patients receive, also called the Hawthorne effect [83]. In our study, patients in the IG will participate in the group sessions, which might lead to an overestimation of the effect of the intervention program. Although in this study the CG is allowed to use usual care, which might lower the difference in attention between IG and CG, effects of the Hawthorne affect cannot be ruled out since participants are not blinded.

A final limitation might be that all data are self-reported. Therefore, as far as possible, we will use validated questionnaires. No objective data will be collected concerning absenteeism. There is ongoing discussion as to whether self-reported data on absenteeism are reliable, although recent evidence showed a high level of similarity between self-reported data and data from, for example, a national insurance authority, and that the use of self-reported data is justified in research [84]. There is also a possibility of recall or information bias. However, because this study is designed as an RCT we expect recall bias to occur to the same extent in both study groups.

Recruitment started in September 2012: inclusion is estimated to be finished in December 2013.