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

Trials

Maria WG Nijhuis-van der Sanden¹  Josephine A Engels²  Yvonne F Heerkens²  J Bart Staal¹  Nathan Hutting² 

[1] Department of Physical Therapy, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands;Department of Occupation & Health, HAN University of Applied Sciences, P.O. Box 6960, 6503, Nijmegen, GL, The Netherlands

关键词: ehealth;    Self-management;    RCT;    RSI;    CANS;   

Others  :  1093226
DOI  :  10.1186/1745-6215-14-258

 received in 2013-04-02, accepted in 2013-08-01,  发布年份 2013

【 摘 要 】

Background

Complaints of the arm, neck, or shoulder (CANS) have a multifactorial origin and cause considerable work problems, including decreased work productivity, sickness absence, and, ultimately, job loss. There is a need for intervention programs for people with CANS. Self-management is an approach used in chronic disease care to improve self-efficacy and wellness behaviors to facilitate participants to make informed choices and carry them out. This study will evaluate the effectiveness of a self-management program (including ehealth) and compare it to usual care among employees with chronic CANS (lasting >3 months).

Methods/design

This is a randomized controlled trial in which 142 participants will be recruited and randomized (with pre-stratification) to either the intervention group (IG) or control group (CG). The IG will participate in a self-management program consisting of six group sessions and an ehealth module. The CG is allowed to use all usual care available. The primary outcome of the study is the self-reported disability of arm, shoulder, and hand, measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). Secondary outcomes include: absenteeism, pain in the previous week, quality of life, catastrophizing pain, self-efficacy, workstyle, presenteeism, fatigue, the use of usual care, and limitations experienced on the job. Data are collected at baseline and at 3, 6, and 12 months follow-up.

Discussion

Following the process of intervention mapping we developed a self-management program to suit and alleviate the problems and needs of employees with CANS. A strength of the study is that our intervention is specifically tailored to match the needs of employees with CANS. The study also has some potential weaknesses (for example, use of co-interventions, combination of group sessions and ehealth, self-reporting of data and possible contamination, Hawthorne effect, and recall or information bias) which are discussed.

Trial registration

The trial is registered with the Dutch Trial Register (http://www.trialregister.nl webciteNTR3816): (January 2013). The first participant was randomized in September 2012.

【 授权许可】

   
2013 Hutting et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Martimo KP, Shiri R, Miranda H, Ketola R, Varonen H, Viikari-Juntura E: Self-reported productivity loss among workers with upper extremity disorders. Scand J Work Environ Health 2009, 35:301-308.
• [2]Huisstede BM, Bierma-Zeinstra SM, Koes BW, Verhaar JA: Incidence and prevalence of upper-extremity musculoskeletal disorders. A systematic appraisal of the literature. BMC Musculoskelet Disord 2006, 7:7.
• [3]Huisstede BM, Wijnhoven HA, Bierma-Zeinstra SM, Koes BW, Verhaar JA, Picavet S: Prevalence and characteristics of complaints of the arm, neck, and/or shoulder (CANS) in the open population. Clin J Pain 2008, 24:253-259.
• [4]Van Tulder M, Malmivaara A, Koes B: Repetitive strain injury. Lancet 2007, 369:1815-1822.
• [5]Karels CH, Bierma-Zeinstra SM, Verhagen AP, Koes BW, Burdorf A: Sickness absence in patients with arm, neck and shoulder complaints presenting in physical therapy practice: 6 months follow-up. Man Ther 2010, 15:476-481.
• [6]Sijbers R: Medewerkers Onderzoek [Employees Survey]. Nijmegen, The Netherlands: HAN University of Applied Sciences; 2012. (Dutch)
• [7]Van Eerd D, Beaton D, Cole D, Lucas J, Hogg-Johnson S, Bombardier C: Classification systems for upper-limb musculoskeletal disorders in workers: a review of the literature. J Clin Epidemiol 2003, 56:925-936.
• [8]Keijsers E, Feleus A, Miedema HS, Koes BW, Bierma-Zeinstra SM: Psychosocial factors predicted nonrecovery in both specific and nonspecific diagnoses at arm, neck, and shoulder. J Clin Epidemiol 2010, 63:1370-1379.
• [9]Esmaeilzadeh S, Ozcan E, Capan N: Effects of ergonomic intervention on work-related upper extremity musculoskeletal disorders among computer workers: a randomized controlled trial. Int Arch Occup Environ Health 2012, PMID: 23263694.
• [10]Martimo KP, Shiri R, Miranda H, Ketola R, Varonen H, Viikari-Juntura E: Effectiveness of an ergonomic intervention on the productivity of workers with upper-extremity disorders–a randomized controlled trial. Scand J Work Environ Health 2010, 36:25-33.
• [11]Van Eijsden-Besseling MD, Van Attekum A, De Bie RA, Staal JB: Pain catastrophizing and lower physical fitness in a sample of computer screen workers with early non-specific upper limb disorders: a case–control study. Ind Health 2010, 48:818-823.
• [12]Sluiter JK, Frings-Dresen MH: Quality of life and illness perception in working and sick-listed chronic RSI patients. Int Arch Occup Environ Health 2008, 81:495-501.
• [13]Huisstede BM, Miedema HS, Verhagen AP, Koes BW, Verhaar JA: Multidisciplinary consensus on the terminology and classification of complaints of the arm, neck and/or shoulder. Occup Environ Med 2007, 64:313-319.
• [14]Peereboom K: RSI Handboek. In RSI manual. Edited by Den H. Dutch: Sdu; 2005.
• [15]Harrington CB, Siddiqui A, Feuerstein M: Workstyle as a predictor of pain and restricted work associated with upper extremity disorders: a prospective study. J Hand Surg Am 2009, 34:724-731.
• [16]Bernaards CM, Bosmans JE, Hildebrandt VH, Van Tulder MW, Heymans MW: The cost-effectiveness of a lifestyle physical activity intervention in addition to a work style intervention on recovery from neck and upper limb symptoms and pain reduction in computer workers. Occup Environ Med 2011, 68:265-272.
• [17]Blatter BHI, Van den Bossche S, Kraan K, Van den Heuvel S: Gezondheidsschade en kosten door RSI en psychosociale arbeidsbelasting. In Health damage and costs caused by RSI and psychosocial workload. Edited by Den H. Dutch: Ministerie van Sociale Zaken en Werkgelegenheid; 2006.
• [18]Uegaki K, De Bruijne MC, Anema JR, van der Beek AJ, Van Tulder MW, Van Mechelen W: Consensus-based findings and recommendations for estimating the costs of health-related productivity loss from a company’s perspective. Scand J Work Environ Health 2007, 33:122-130.
• [19]van den Heuvel SG, Ijmker S, Blatter BM, De Korte EM: Loss of productivity due to neck/shoulder symptoms and hand/arm symptoms: results from the PROMO-study. J Occup Rehabil 2007, 17:370-382.
• [20]Van Eijsden-Besseling MD, Peeters FP, Reijnen JA, De Bie RA: Perfectionism and coping strategies as risk factors for the development of non-specific work-related upper limb disorders (WRULD). Occup Med (Lond) 2004, 54:122-127.
• [21]Feleus A, Bierma-Zeinstra SM, Miedema HS, Verhagen AP, Nauta AP, Burdorf A, Verhaar JA, Koes BW: Prognostic indicators for non-recovery of non-traumatic complaints at arm, neck and shoulder in general practice–6 months follow-up. Rheumatology (Oxford) 2007, 46:169-176.
• [22]Bongers PM, Ijmker S, van den Heuvel S, Blatter BM: Epidemiology of work related neck and upper limb problems: psychosocial and personal risk factors (part I) and effective interventions from a bio behavioural perspective (part II). J Occup Rehabil 2006, 16:279-302.
• [23]Staal JB, De Bie RA, Hendriks EJ: Aetiology and management of work-related upper extremity disorders. Best Pract Res Clin Rheumatol 2007, 21:123-133.
• [24]Macfarlane GJ, Hunt IM, Silman AJ: Role of mechanical and psychosocial factors in the onset of forearm pain: prospective population based study. BMJ 2000, 321:676-679.
• [25]Andersen JH, Kaergaard A, Mikkelsen S, Jensen UF, Frost P, Bonde JP, Fallentin N, Thomsen JF: Risk factors in the onset of neck/shoulder pain in a prospective study of workers in industrial and service companies. Occup Environ Med 2003, 60:649-654.
• [26]Marcus M, Gerr F, Monteilh C, Ortiz DJ, Gentry E, Cohen S, Edwards A, Ensor C, Kleinbaum D: A prospective study of computer users: II. Postural risk factors for musculoskeletal symptoms and disorders. Am J Ind Med 2002, 41:236-249.
• [27]Bernard B, Sauter S, Fine L, Petersen M, Hales T: Job task and psychosocial risk factors for work-related musculoskeletal disorders among newspaper employees. Scand J Work Environ Health 1994, 20:417-426.
• [28]van den Heuvel SG, van der Beek AJ, Blatter BM, Hoogendoorn WE, Bongers PM: Psychosocial work characteristics in relation to neck and upper limb symptoms. Pain 2005, 114:47-53.
• [29]Nicholas RA, Feuerstein M, Suchday S: Workstyle and upper-extremity symptoms: a biobehavioral perspective. J Occup Environ Med 2005, 47:352-361.
• [30]Feuerstein M, Harrington CB: Secondary prevention of work-related upper extremity disorders: recommendations from the Annapolis conference. J Occup Rehabil 2006, 16:401-409.
• [31]Meijer EM, Sluiter JK, Frings-Dresen MH: Is workstyle a mediating factor for pain in the upper extremity over time? J Occup Rehabil 2008, 18:262-266.
• [32]Sharan D, Parijat P, Sasidharan AP, Ranganathan R, Mohandoss M, Jose J: Workstyle risk factors for work related musculoskeletal symptoms among computer professionals in India. J Occup Rehabil 2011, 21:520-525.
• [33]Verhagen AP, Karels C, Bierma-Zeinstra SM, Feleus A, Dahaghin S, Burdorf A, De Vet HC, Koes BW: Ergonomic and physiotherapeutic interventions for treating work-related complaints of the arm, neck or shoulder in adults. A Cochrane systematic review. Eura Medicophys 2007, 43:391-405.
• [34]Verhagen AP, Bierma-Zeinstra SM, Feleus A, Karels C, Dahaghin S, Burdorf L, De Vet HC, Koes BW: Ergonomic and physiotherapeutic interventions for treating upper extremity work related disorders in adults. Cochrane Database Syst Rev 2004., 1CD003471
• [35]Hoe VC, Urquhart DM, Kelsall HL, Sim MR: Ergonomic design and training for preventing work-related musculoskeletal disorders of the upper limb and neck in adults. Cochrane Database Syst Rev 2012., 8CD008570
• [36]Multidisciplinaire richtlijn aspecifieke Klachten Arm: Nek en/of Schouders [Multidisciplinary guideline non-specific complaints of arm, neck and / or shoulders]. Amersfoort: Koninklijk Nederlands Genootschap voor Fysiotherapie. Dutch: KNGF; 2012.
• [37]Cole DC, Van Eerd D, Bigelow P, Rivilis I: Integrative interventions for MSDs: nature, evidence, challenges & directions. J Occup Rehabil 2006, 16:359-374.
• [38]Bernaards CM, Ariens GA, Simons M, Knol DL, Hildebrandt VH: Improving work style behavior in computer workers with neck and upper limb symptoms. J Occup Rehabil 2008, 18:87-101.
• [39]Bernaards CM, Ariens GA, Knol DL, Hildebrandt VH: The effectiveness of a work style intervention and a lifestyle physical activity intervention on the recovery from neck and upper limb symptoms in computer workers. Pain 2007, 132:142-153.
• [40]Hooftman W, Klein Hesselink J, Van Genabeek J, Wiezer N, Willems D: Arbobalans 2010: Kwaliteit van de arbeid, effecten en maatregelen in Nederland [Quality of work, effects and measures in the Netherlands. Dutch: TNO; 2010:2011.
• [41]Lorig KR, Mazonson PD, Holman HR: Evidence suggesting that health education for self-management in patients with chronic arthritis has sustained health benefits while reducing health care costs. Arthritis Rheum 1993, 36:439-446.
• [42]Barlow J, Wright C, Sheasby J, Turner A, Hainsworth J: Self-management approaches for people with chronic conditions: a review. Patient Educ Couns 2002, 48:177-187.
• [43]Lorig KR, Holman H: Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med 2003, 26:1-7.
• [44]Ellis N, Johnston V, Gargett S, MacKenzie A, Strong J, Battersby M, McLeod R, Adam K, Jull G: Does self-management for return to work increase the effectiveness of vocational rehabilitation for chronic compensated musculoskeletal disorders? Protocol for a randomised controlled trial. BMC Musculoskelet Disord 2010, 11:115.
• [45]Newman S, Steed L, Mulligan K: Self-management interventions for chronic illness. Lancet 2004, 364:1523-1537.
• [46]Carnes D, Homer KE, Miles CL, Pincus T, Underwood M, Rahman A, Taylor SJ: Effective delivery styles and content for self-management interventions for chronic musculoskeletal pain: a systematic literature review. Clin J Pain 2012, 28:344-354.
• [47]Nolte S, Osborne RH: A systematic review of outcomes of chronic disease self-management interventions. Qual Life Res 2012, PMID 23111571.
• [48]Du S, Yuan C, Xiao X, Chu J, Qiu Y, Qian H: Self-management programs for chronic musculoskeletal pain conditions: a systematic review and meta-analysis. Patient Educ Couns 2011, 85:e299-e310.
• [49]Gustavsson C, Denison E, Von Koch L: Self-management of persistent neck pain: a randomized controlled trial of a multi-component group intervention in primary health care. Eur J Pain 2010, 14:630 e631-630 e611.
• [50]Detaille SI, van der Gulden JW, Engels JA, Heerkens YF, Van Dijk FJ: Using intervention mapping (IM) to develop a self-management programme for employees with a chronic disease in the Netherlands. BMC Publ Health 2010, 10:353.
• [51]Detaille SI, van der Gulden JW, Engels JA, Heerkens YF, Van Dijk FJ: Building a self-management program for workers with a chronic somatic disease. Nijmegen: PhD thesis; 2012.
• [52]Bartholomew LK, Parcel GS, Kok G: Intervention mapping: a process for developing theory- and evidence-based health education programs. Health Educ Behav 1998, 25:545-563.
• [53]Bartholomew LK, Parcel GS, Kok G, Gottlieb NH: Planning Health Promotion Programs: An Intervention Mapping Approach. San Francisco, CA: Jossey-Bass; 2006.
• [54]Terluin B, Van Marwijk HW, Ader HJ, De Vet HC, Penninx BW, Hermens ML, Van Boeijen CA, Van Balkom AJ, van der Klink JJ, Stalman WA: The Four-Dimensional Symptom Questionnaire (4DSQ): a validation study of a multidimensional self-report questionnaire to assess distress, depression, anxiety and somatization. BMC Psychiatry 2006, 6:34.
• [55]Schulz KF, Altman DG, Moher D: CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother 2010, 1:100-107.
• [56]Intervention mapping. 2013. http://interventionmapping.com/ webcite
• [57]Beaton DE, Katz JN, Fossel AH, Wright JG, Tarasuk V, Bombardier C: Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. J Hand Ther 2001, 14:128-146.
• [58]Veehof MM, Sleegers EJ, Van Veldhoven NH, Schuurman AH, Van Meeteren NL: Psychometric qualities of the Dutch language version of the Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH-DLV). J Hand Ther 2002, 15:347-354.
• [59]Koopman C, Pelletier KR, Murray JF, Sharda CE, Berger ML, Turpin RS, Hackleman P, Gibson P, Holmes DM, Bendel T: Stanford presenteeism scale: health status and employee productivity. J Occup Environ Med 2002, 44:14-20.
• [60]Hutting N, Engels JA, Heerkens YF, Staal JB, Der Sanden MWG N-v: Development and measurement properties of the Dutch version of the Stanford Presenteeism Scale (SPS-6). J Occup Rehabil 2013. http://link.springer.com/content/pdf/10.1007%2Fs10926-013-9453-x.pdf webcite
• [61]Lerner D, Amick BC 3rd, Rogers WH, Malspeis S, Bungay K, Cynn D: The Work Limitations Questionnaire. Med Care 2001, 39:72-85.
• [62]Jensen MP, Miller L, Fisher LD: Assessment of pain during medical procedures: a comparison of three scales. Clin J Pain 1998, 14:343-349.
• [63]Katz J, Melzack R: Measurement of pain. Surg Clin North Am 1999, 79:231-252.
• [64]Price DD, Bush FM, Long S, Harkins SW: A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain 1994, 56:217-226.
• [65]Mintken PE, Glynn P, Cleland JA: Psychometric properties of the shortened disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) and Numeric Pain Rating Scale in patients with shoulder pain. J Shoulder Elbow Surg 2009, 18:920-926.
• [66]Cleland JA, Childs JD, Whitman JM: Psychometric properties of the Neck Disability Index and Numeric Pain Rating Scale in patients with mechanical neck pain. Arch Phys Med Rehabil 2008, 89:69-74.
• [67]Sullivan M, Bishop S, Pivik J: The Pain Catastrophizing Scale: development and validation. Psychol Assess 1995, 7:524-532.
• [68]Osman A, Barrios FX, Gutierrez PM, Kopper BA, Merrifield T, Grittmann L: The Pain Catastrophizing Scale: further psychometric evaluation with adult samples. J Behav Med 2000, 23:351-365.
• [69]Osman A, Barrios FX, Kopper BA, Hauptmann W, Jones J, O’Neill E: Factor structure, reliability, and validity of the Pain Catastrophizing Scale. J Behav Med 1997, 20:589-605.
• [70]Lame IE, Peters ML, Kessels AG, Van Kleef M, Patijn J: Test–retest stability of the Pain Catastrophizing Scale and the Tampa Scale for Kinesiophobia in chronic pain over a longer period of time. J Health Psychol 2008, 13:820-826.
• [71]Dutch adaptation of the general self-efficacy scale. 2013. http://userpage.fu-berlin.de/~health/dutch.htm webcite
• [72]Vercoulen JH, Swanink CM, Fennis JF, Galama JM, van der Meer JW, Bleijenberg G: Dimensional assessment of chronic fatigue syndrome. J Psychosom Res 1994, 38:383-392.
• [73]Van Dierendonck D, Schaufeli WB, Buunk BP: Burnout and inequity among human service professionals: a longitudinal study. J Occup Health Psychol 2001, 6:43-52.
• [74]Maslach C, Jackson SE, Leiter MP: Maslach burnout inventory manual. 3rd edition. Palo Alto, CA: Consulting Psychologists Press; 1996.
• [75]Schaufeli WB, Bakker AB, Hoogduin K, Schaap C, Kladler A: on the clinical validity of the maslach burnout inventory and the burnout measure. Psychol Health 2001, 16:565-582.
• [76]Feuerstein M, Nicholas RA: Development of a short form of the Workstyle measure. Occup Med (Lond) 2006, 56:94-99.
• [77]Van Veldhoven M, Meijman TF, Broersen JPJ, Fortuin RJ: Handleiding VBBA [Manual VBBA]. Dutch: SKB Vragenlijst Services; 2002.
• [78]Ware J Jr, Kosinski M, Keller SD: A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996, 34:220-233.
• [79]Grant AM, Franklin J, Langford P: The Self-reflection and Insight Scale: a new measure of private self-consciousness. Soc Behav Pers 2001, 30:821-836.
• [80]Bron C, De Gast A, Dommerholt J, Stegenga B, Wensing M, Oostendorp RA: Treatment of myofascial trigger points in patients with chronic shoulder pain: a randomized, controlled trial. BMC Med 2011, 9:8.
• [81]Gummesson C, Atroshi I, Ekdahl C: The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord 2003, 4:11.
• [82]Van Eijsden-Besseling MD, Staal JB, Van Attekum A, De Bie RA, van den Heuvel WJ: No difference between postural exercises and strength and fitness exercises for early, non-specific, work-related upper limb disorders in visual display unit workers: a randomised trial. Aust J Physiother 2008, 54:95-101.
• [83]Wickstrom G, Bendix T: The “Hawthorne effect”-what did the original Hawthorne studies actually show? Scand J Work Environ Health 2000, 26:363-367.
• [84]Linton SJ: Correspondence of back pain patients’ self-reports of sick leave and Swedish National Insurance Authority register. Percept Mot Skills 2011, 112:133-137.