|- candidate number||14257|
|- NTR Number||NTR3816|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-jan-2013|
|- Secondary IDs||NL40737.091.12 CCMO|
|- Public Title||Self management and employability of workers with complaints of the arm, neck and / or shoulder.|
|- Scientific Title||Self management and employability of workers with complaints of the arm, neck and / or shoulder.|
|- ACRONYM||Self management and employability of workers with CANS.|
|- hypothesis||The objective of the study is to investigate the effectiveness of a combined intervention on the disabilities, self-efficacy and long-term employability of workers with complaints of the arm, neck and / or shoulder. Through a self-management program - complemented by an e-health program – the employees is given insight into the causes of the symptoms and disabilities and they get better equipped to deal with these complaints and lower the risk of persistence of the complaints and control to workplace absenteeism.|
|- Healt Condition(s) or Problem(s) studied||Upper limb dysfunctions, Neck complaints, Upper extremity, Complaints of shoulder, Work-related disorders of upper limbs, RSI|
|- Inclusion criteria||1. Employee is to his / her judgment limited in performing his/her work (related to CANS);|
2. Employee suffers from work-related complaints;
3. The complaints must exist for at least 12 weeks, where there may be a continuous or intermittent course.
|- Exclusion criteria||1. Red flags;|
2. Complaints caused by a systemic disease;
3. Complaints caused by traumatic injury;
4. Suspicion of specific CANS;
5. Suspicion of mental pathology (> 4 pointson subscale depression, measured with Four Dimensional Symptom Questionnaire [4DSQ].
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||25-sep-2012|
|- planned closingdate||1-aug-2014|
|- Target number of participants||150|
|- Interventions||A self-management intervention offered to the participants (8-12 participants in each group). The total program consists of six group meetings of two and a half hours each. The meetings are weekly. Topics such as dealing with pain, disability and fatigue, the balance between workload and capacity, communication skills, stress management, (muscle) relaxation exercises, problem solving, use of facilities, working with others and asking for help, dealing with negative emotions and positive thinking will be discussed.
To influence the determinants of behaviour various techniques are used in the course. Such as consciousness raising, risk perception, positive (re)-formulation, self-(re) evaluation), obtaining confidence en mobilizing social support, skill training, reinterpretation of symptoms, goal setting, social comparison and modelling (Bandura 1986). To set targets (SMART and formulated in terms of behaviour), action plans will be made (Lorig et al, 2006). A goal about management behaviour (eg exercises, take breaks at work, ask the manager for a tool), including a statement of the employee on which he / she indicates how confident he / she is in achieving the goal, will be formulated weekly. Thus unrealistic goals can be adjusted.
The group meetings are complemented by an e-health module. In the e-health module the subjects of self-management training are also discussed and assignments can be made. Also, participants can keep a diary. There is also additional information about self-management and on specific topics of CANS availible, such as: etiological factors (physical, psychological and social (work) factors), prognostic factors, lifestyle factors, and other modifiable factors.
The control group will receive care as usual.
|- Primary outcome||The primary outcome measure is the patient reported limitations (in the previous week) of arm, shoulder and hand, measured on the Disabilities of the Arm, Shoulder and Hand Outcome Measure (DASH).|
|- Secondary outcome||Secondary outcome measures are: (between () used questionnaires):|
1. Self reported absenteeism;
2. Pain (Numeric Rating Scale);
3. Quality of life (SF-12);
4. Pain Catastrophizing (Pain Catastrophizing Scale Dutch Version);
5. Self-efficacy at work (Quenstionnaire Self-efficacy at work, Detaille);
6. Self-efficacy (Dutch General Self-Efficacy Scale);
7. Workstyle (Workstyle Short Form);
8. Presenteism (Stanford Presenteeism Scale, SPS-6);
9. Fatique (Checklist Individual Strength);
10. Work experiences (Utrecht Burnout Scale, subscale work experiences);
11. Subscales ‘work rate', 'amount of work’, 'relation executive's, ' relation colleague's, ‘need for recovery’, 'participation' and 'empowerment in the workplace' of the Beleving en Beoordeling van de Arbeid questionnaire;
12. Self-reflection and Insight (Self-reflection and Insight Scale);
13. Work limitations (Work Limitations Questionnaire);
14. Use of usual care.
|- Timepoints||T0: Baseline;|
T1: 3 months;
T2: 6 months;
T3: 12 months.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. M.W.G. Nijhuis - van der Sanden|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. M.W.G. Nijhuis - van der Sanden|
|- Sponsor/Initiator ||HAN University of Applied Sciences|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The increased use of computers in many professions in recent decades has been accompanied by an increased incidence of pain and symptoms in the upper extremity in the execution of repetitive work. These RSI (Repetitive Strain Injury) complaints not only lead to great discomfort and pain but in some cases also to non-attendance at work and / or work disability. In the absence of effective interventions, many employees continue to perform their work with pain and limitations resulting in a reduced work capacity, reduced productivity at work (presenteeism), decreased job satisfaction and possibly in absenteeism and disability. Focussing on an active coping strategy in which employees learn how to deal with the symptoms and limitations seems advisable (Heemskerk et al, 2009). Self-management can both influence physical and psychosocial risk factors of CANS. Because CANS have a chronic of intermittent course in many cases, such an intervention seems ideal for workers with persistent CANS.
The study is a randomized controlled trail in which employees are randomly assigned to a self-management intervention and an e-health program or to usual care. Participants are recruited through a call on the websites and newsletters and through health coordinators, occupational health physicians and managers. The self-management intervention consists of six group sessions over 2 months. The e-health is available for participants from the start of the intervention till the end of the follow-up period. The follow-up period is 12 months.
The objective of the study is to investigate the effectiveness of a combined intervention on the disabilities, self-efficacy and long-term employability of workers with complaints of the arm, neck and / or shoulder. Through a self-management program - complemented by an e-health program – the employees is given insight into the causes of the symptoms and disabilities and they get better equipped to deal with these complaints and lower the risk of persistence of the complaints and control to workplace absenteeism.
|- Main changes (audit trail)||23-Mar-2013: Inclusion criteria added: 4. Participant is working for at least 12 hours a week. The closing date has been changed to 31-Dec-2014. Target number of participants will be 142 - NM|
|- RECORD||24-jan-2013 - 23-mrt-2013|