Early coordinated multidisciplinary intervention to prevent sickness absence and labour market exclusion in patients with low back pain: study protocol of a randomized controlled trial

Annette Fisker, Henning Langberg, Tom Petersen, Ole Steen Mortensen, Annette Fisker, Henning Langberg, Tom Petersen, Ole Steen Mortensen

Abstract

Background: Musculoskeletal disorders account for one third of the long-term absenteeism in Denmark and the number of individuals sick listed for more than four weeks is increasing. Compared to other diagnoses, patients with musculoskeletal diseases, including low back pain, are less likely to return to work after a period of sick leave. It seems that a multidisciplinary intervention, including cooperation between the health sector, the social sector and in the work place, has a positive effect on days off work due to musculoskeletal disorders and particularly low back pain. It is a challenge to coordinate this type of intervention, and the implementation of a return-to-work (RTW)-coordinator is suggested as an effective strategy in this process. The purpose of this paper is to describe the study protocol and present a new type of intervention, where the physiotherapist both has the role as RTW-coordinator and treating the patient.

Methods/design: A randomized controlled trial (RCT) is currently on-going. The RCT includes 770 patients with low back pain of minimum four weeks who are referred to an outpatient back centre. The study population consists of patients, who are sick-listed or at risk of sick-leave due to LBP. The control group is treated with usual care in a team of a physiotherapist, a chiropractor, a rheumatologist and a social worker employed at the centre. The Intervention group is treated with usual care and in addition intervention of a psychologist, an occupational physician, an ergonomist, a case manager from the municipal sickness benefit office, who has the authority in the actual case concerning sickness benefit payment and contact to the patients employer/work place. The treating physiotherapist is the RTW-coordinator. Outcome will be reported at the end of treatment as well as 6 and 12 months follow up. The primary outcome is number of days off work. Secondary outcomes are disability, pain, and quality of life. The study will follow the recommendations in CONSORT-statement in designing and reporting RCTs.

Discussion: This large RCT is testing the effectiveness of a preventive intervention targeting patients on short term sick leave or at risk being sick listed because of low back pain. We have developed a novel multidisciplinary team structure using the treating physiotherapist as the return to work coordinator, and having the case manager from the municipal sickness benefit office participating in team meetings. The study has the potential to contribute to the knowledge about how to target the challenges in the treatment of LBP. The aim is to prevent sickness absence and labour market exclusion--both on the individual level and economic costs at community level. Short term results will be available in 2014.This study is approved by the Danish Regional Ethics Committee (J.nr: H-C-2008-112) and is registered at

Trial registration: ClinicalTrials.gov: NCT01690234.

Figures

Figure 1
Figure 1
Recruitment and expected patient flow.
Figure 2
Figure 2
Criterions for involvement of the health professionals in the intervention group.

References

    1. Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81:646–656.
    1. Mortensen OS, Andersen J, Ektor-Andersen J, Eriksen HR, Fallentin N, Frost P. Hvidbog om sygefravær og tilbagevenden til arbejde ved muskel- og skeletbesvær. Årsager og handlemuligheder. Copenhagen, Denmark: National Research Centre for the Working Environment (NRCWE); 2008.
    1. Analyse af Sygefraværet. Copenhagen, Denmark: Beskæftigelsesministeriet; 2008. Ref Type: Report.
    1. Koch M, Davidsen M, Juel K. De samfundsmæssige omkostninger ved rygsygdomme og rygsmerter i Danmark. Danmark: Statens Institut for Folkesundhed. Syddansk Universitet; 2011.
    1. OECD. Sickness, Disability and Work. Breaking the barriers. A synthesis of Findings across OECD Countries. Paris: OECD; 2010.
    1. Steenstra IA, Verbeek JH, Heymans MW, Bongers PM. Prognostic factors for duration of sick leave in patients sick listed with acute low back pain: a systematic review of the literature. Occup Environ Med. 2005;62:851–860. doi: 10.1136/oem.2004.015842.
    1. Storheim K, Brox JI, Holm I, Bo K. Predictors of return to work in patients sick listed for sub-acute low back pain: a 12-month follow-up study. J Rehabil Med. 2005;37:365–371. doi: 10.1080/16501970510040344.
    1. Labriola M. Work environment factors associated with long-term sickness absence and return to work. Copenhagen, Denmark: National Institute of Occupational Health; 2006.
    1. Pincus T, Burton AK, Vogel S, Field AP. A systematic review of psychological factors as predictors of chronicity/disability in prospective cohorts of low back pain. Spine (Phila Pa 1976) 2002;27:E109–E120. doi: 10.1097/00007632-200203010-00017.
    1. Iles RA, Davidson M, Taylor NF. Psychosocial predictors of failure to return to work in non-chronic non-specific low back pain: a systematic review. Occup Environ Med. 2008;65:507–517.
    1. Labriola M, Lund T, Christensen KB, Kristensen TS. Multilevel analysis of individual and contextual factors as predictors of return to work. J Occup Environ Med. 2006;48:1181–1188. doi: 10.1097/01.jom.0000243359.52562.a5.
    1. Hoogendoorn WE, Bongers PM, de HC V, Ariens GA, Van MW, Bouter LM. High physical work load and low job satisfaction increase the risk of sickness absence due to low back pain: results of a prospective cohort study. Occup Environ Med. 2002;59:323–328. doi: 10.1136/oem.59.5.323.
    1. Rehabilitation in Denmark. Hvidbog om rehabilteringsbegrebet. Aarhus, Denmark: MarselisborgCenteret and Rehabiliteringsforum Denmark; 2004.
    1. Stucki G, Cieza A, Melvin J. The International Classification of Functioning, Disability and Health (ICF): a unifying model for the conceptual description of the rehabilitation strategy. J Rehabil Med. 2007;39:279–285. doi: 10.2340/16501977-0041.
    1. Burton AK, Balague F, Cardon G, Eriksen HR, Henrotin Y, Lahad A. Chapter 2. European guidelines for prevention in low back pain: November 2004. Eur Spine J. 2006;15(2):S136–S168. doi: 10.1007/s00586-006-1070-3.
    1. Gabbay M, Taylor L, Sheppard L, Hillage J, Bambra C, Ford F. NICE guidance on long-term sickness and incapacity. Br J Gen Pract. 2011;61:e118–e124. doi: 10.3399/bjgp11X561221.
    1. Franche RL, Cullen K, Clarke J, Irvin E, Sinclair S, Frank J. Workplace-based return-to-work interventions: a systematic review of the quantitative literature. J Occup Rehabil. 2005;15:607–631. doi: 10.1007/s10926-005-8038-8.
    1. Løvschall C, Bech M, Rasmussen C, Petersen T, Hartvigsen J, Jensen C. Tværdisciplinær og tværsektoriel indsats over for patienter med ondt i ryggen - en medicinsk teknologivurdering. Copenhagen, Denmark: Sundhedsstyrelsen, Monitorering & Medicinsk Teknologivurdering; 2010. Ref Type: Generic.
    1. Palmer KT, Harris EC, Linaker C, Barker M, Lawrence W, Cooper C. Effectiveness of community- and workplace-based interventions to manage musculoskeletal-related sickness absence and job loss: a systematic review. Rheumatology (Oxford) 2012;51:230–242. doi: 10.1093/rheumatology/ker086.
    1. Maceachen E, Clarke J, Franche RL, Irvin E. Systematic review of the qualitative literature on return to work after injury. Scand J Work Environ Health. 2006;32:257–269. doi: 10.5271/sjweh.1009.
    1. Lamb SE, Hansen Z, Lall R, Castelnuovo E, Withers EJ, Nichols V. Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis. Lancet. 2010;375:916–923. doi: 10.1016/S0140-6736(09)62164-4.
    1. Bell JA, Burnett A. Exercise for the primary, secondary and tertiary prevention of low back pain in the workplace: a systematic review. J Occup Rehabil. 2009;19:8–24. doi: 10.1007/s10926-009-9164-5.
    1. Henschke N, Ostelo RW, van Tulder MW, Vlaeyen JW, Morley S, Assendelft WJ. Behavioural treatment for chronic low-back pain. Cochrane Database Syst Rev. 2010. CD002014.
    1. Bigos SJ, Holland J, Holland C, Webster JS, Battie M, Malmgren JA. High-quality controlled trials on preventing episodes of back problems: systematic literature review in working-age adults. Spine J. 2009;9:147–168. doi: 10.1016/j.spinee.2008.11.001.
    1. Driessen MT, Proper KI, van Tulder MW, Anema JR, Bongers PM, van der Beek AJ. The effectiveness of physical and organisational ergonomic interventions on low back pain and neck pain: a systematic review. Occup Environ Med. 2010;67:277–285. doi: 10.1136/oem.2009.047548.
    1. COST Action B13. European guidelines for the management of chronic non-specific low back pain. University of Bergen, Norway: European Commision Research Diractorate General. Low Back Pain: Guidelines for its Management; 2004.
    1. Shaw W, Hong QN, Pransky G, Loisel P. A literature review describing the role of return-to-work coordinators in trial programs and interventions designed to prevent workplace disability. J Occup Rehabil. 2008;18:2–15. doi: 10.1007/s10926-007-9115-y.
    1. Bultmann U, Sherson D, Olsen J, Hansen CL, Lund T, Kilsgaard J. Coordinated and tailored work rehabilitation: a randomized controlled trial with economic evaluation undertaken with workers on sick leave due to musculoskeletal disorders. J Occup Rehabil. 2009;19:81–93. doi: 10.1007/s10926-009-9162-7.
    1. Vinter NC, Jensen C, Thorsteinsson E. Hospitalsbaseret rehabilitering af sygemeldte. Beskrivelse af den tværfaglige og tværsektorielle indsats. Aarhus, Denmark: Region Midtjylland, Center for Folkesundhed; 2008.
    1. Loisel P, Abenhaim L, Durand P, Esdaile JM, Suissa S, Gosselin L. A population-based, randomized clinical trial on back pain management. Spine (Phila Pa 1976) 1997;22:2911–2918. doi: 10.1097/00007632-199712150-00014.
    1. Anema JR, Steenstra IA, Bongers PM, de Vet HC, Knol DL, Loisel P. Multidisciplinary rehabilitation for subacute low back pain: graded activity or workplace intervention or both? A randomized controlled trial. Spine (Phila Pa 1976) 2007;32:291–298. doi: 10.1097/.
    1. Jensen LD, Maribo T, Schiottz-Christensen B, Madsen FH, Gonge B, Christensen M. Counselling low-back-pain patients in secondary healthcare: a randomised trial addressing experienced workplace barriers and physical activity. Occup Environ Med. 2012;69:21–28. doi: 10.1136/oem.2010.064055.
    1. Hjollund NH, Larsen FB, Andersen JH. Register-based follow-up of social benefits and other transfer payments: accuracy and degree of completeness in a Danish interdepartmental administrative database compared with a population-based survey. Scand J Public Health. 2007;35:497–502. doi: 10.1080/14034940701271882.
    1. Manniche C, Asmussen K, Lauritsen B, Vinterberg H, Kreiner S, Jordan A. Low Back Pain Rating scale: validation of a tool for assessment of low back pain. Pain. 1994;57:317–326. doi: 10.1016/0304-3959(94)90007-8.
    1. Albert HB, Jensen AM, Dahl D, Rasmussen MN. Criteria validation of the Roland Morris questionnaire. A Danish translation of the international scale for the assessment of functional level in patients with low back pain and sciatica. Ugeskr Laeger. 2003;165:1875–1880.
    1. Patrick DL, Deyo RA, Atlas SJ, Singer DE, Chapin A, Keller RB. Assessing health-related quality of life in patients with sciatica. Spine (Phila Pa 1976) 1995;20:1899–1908. doi: 10.1097/00007632-199509000-00011.
    1. Bjørner JB. Dansk manual til SF-36. Et spørgeskema om helbredsstatus. Copenhagen, Denmark: Lægemiddelindustriforeningen; 1997.
    1. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–483. doi: 10.1097/00005650-199206000-00002.
    1. Olsen LR, Mortensen EL, Bech P. The SCL-90 and SCL-90R versions validated by item response models in a Danish community sample. Acta Psychiatr Scand. 2004;110:225–229. doi: 10.1111/j.1600-0447.2004.00399.x.
    1. Derogatis LR, Lipman RS, Covi L. SCL-90: an outpatient psychiatric rating scale–preliminary report. Psychopharmacol Bull. 1973;9:13–28.
    1. Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993;52:157–168. doi: 10.1016/0304-3959(93)90127-B.
    1. Hoegh M, Jacobsen JS, Mogensen KM, Petersen T. Fear Avoidance Beliefs Questionnaire, Danish version. 2010.
    1. Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ. 2002;21:271–292. doi: 10.1016/S0167-6296(01)00130-8.
    1. van Oostrom SH, Driessen MT, de Vet HC, Franche RL, Schonstein E, Loisel P. Workplace interventions for preventing work disability. Cochrane Database Syst Rev. 2009. CD006955.
    1. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. doi: 10.1136/bmj.c869.
    1. Moons KG, Royston P, Vergouwe Y, Grobbee DE, Altman DG. Prognosis and prognostic research: what, why, and how? BMJ. 2009;338:b375. doi: 10.1136/bmj.b375.

Source: PubMed

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