Effectiveness of three interventions for secondary prevention of low back pain in the occupational health setting - a randomised controlled trial with a natural course control

J Rantonen, J Karppinen, A Vehtari, S Luoto, E Viikari-Juntura, M Hupli, A Malmivaara, S Taimela, J Rantonen, J Karppinen, A Vehtari, S Luoto, E Viikari-Juntura, M Hupli, A Malmivaara, S Taimela

Abstract

Background: We assessed the effectiveness of three interventions that were aimed to reduce non-acute low back pain (LBP) related symptoms in the occupational health setting.

Methods: Based on a survey (n = 2480; response rate 71%) on LBP, we selected a cohort of 193 employees who reported moderate LBP (Visual Analogue Scale VAS > 34 mm) and fulfilled at least one of the following criteria during the past 12 months: sciatica, recurrence of LBP ≥ 2 times, LBP ≥ 2 weeks, or previous sickness absence. A random sample was extracted from the cohort as a control group (Control, n = 50), representing the natural course of LBP. The remaining 143 employees were invited to participate in a randomised controlled trial (RCT) of three 1:1:1 allocated parallel intervention arms: multidisciplinary rehabilitation (Rehab, n = 43); progressive exercises (Physio, n = 43) and self-care advice (Advice, n = 40). Seventeen employees declined participation in the intervention. The primary outcome measures were physical impairment (PHI), LBP intensity (Visual Analogue Scale), health related quality of life (QoL), and accumulated sickness absence days. We imputed missing values with multiple imputation procedure. We assessed all comparisons between the intervention groups and the Control group by analysing questionnaire outcomes at 2 years with ANOVA and sickness absence at 4 years by using negative binomial model with a logarithmic link function.

Results: Mean differences between the Rehab and Control groups were - 3 [95% CI -5 to - 1] for PHI, - 13 [- 24 to - 1] for pain intensity, and 0.06 [0.00 to 0.12] for QoL. Mean differences between the Physio and Control groups were - 3 [95% CI -5 to - 1] for PHI, - 13 [- 29 to 2] for pain intensity, and 0.07 [0.01 to 0.13] for QoL. The main effects sizes were from 0.4 to 0.6. The interventions were not effective in reducing sickness absence.

Conclusions: Rehab and Physio interventions improved health related quality of life, decreased low back pain and physical impairment in non-acute, moderate LBP, but we found no differences between the Advice and Control group results. No effectiveness on sickness absence was observed.

Trial registration: Number NCT00908102 Clinicaltrials.gov.

Keywords: Disability; Early management; Graded activity; LBP; Multidisciplinary; Natural course of LBP; Population based; Quasi-randomised design; RCT; Rehabilitation; Sickness absence; Usual care.

Conflict of interest statement

Authors’ information

The corresponding author, Dr. Jarmo Rantonen is working as an occupational health physician in Finland and concurrently finishing his thesis about secondary prevention of low back pain.

Ethics approval and consent to participate

The South Karelian Central Hospital Research Ethics Board approved the study on 13.09.2001. All participants received written information regarding the study, in accordance with the Declaration of Helsinki. Only the participants who gave their signed informed consent were included in the study. The documents above are stored with the other study material.

Competing interests

JR, SL, AV, JK, and AM have no competing interests to declare. During Rehab and Physio interventions. MH was the head physician of the physical medicine unit and ST was the Medical Director of DBC International. There are no other competing interests to declare.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The flow chart of the study and the number of participants at different stages of the trial

References

    1. Balagué F, Mannion AF, Pellisé F, Cedraschi C. Non-specific low back pain. Lancet. 2012;379(9814):482–491. doi: 10.1016/S0140-6736(11)60610-7.
    1. Stanton TR, Latimer J, Maher CG, Hancock MJ. How do we define the condition ‘recurrent low back pain’? A systematic review. Eur Spine J. 2010;19(4):533–539. doi: 10.1007/s00586-009-1214-3.
    1. Hoy D, Brooks P, Blyth F, Buchbinder R. The epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010;24(6):769–781. doi: 10.1016/j.berh.2010.10.002.
    1. Hoy D, March L, Brooks P, Woolf A, Blyth F, Vos T, Buchbinder R. Measuring the global burden of low back pain. Best Pract Res Clin Rheumatol. 2010;24(2):155–165. doi: 10.1016/j.berh.2009.11.002.
    1. Burton AK, Balague F, Cardon G, Eriksen HR, Henrotin Y, Lahad A, Leclerc A, Muller G, van der Beek AJ. Chapter 2. European guidelines for prevention in low back pain : November 2004. Eur Spine J. 2006;15 Suppl 2:S136–S168. doi: 10.1007/s00586-006-1070-3.
    1. Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, et al. The global burden of low back pain: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014;73(6):968–974. doi: 10.1136/annrheumdis-2013-204428.
    1. Steenstra IA, Anema JR, van Tulder MW, Bongers PM, de Vet HC, van Mechelen W. Economic evaluation of a multi-stage return to work program for workers on sick-leave due to low back pain. J Occup Rehabil. 2006;16(4):557–578. doi: 10.1007/s10926-006-9053-0.
    1. Choi KLB, Verbeek JH, Tam WW, Jiang JYY. Exercises for prevention of recurrences of low-back pain. Cochrane Database Syst Rev. 2011;(2).
    1. Schaafsma FG, Anema JR, van der Beek AJ. Back pain: prevention and management in the workplace. Best Pract Res Clin Rheumatol. 2015;29(3):483–494. doi: 10.1016/j.berh.2015.04.028.
    1. Mairiaux P, Loomis D. Randomised trials on secondary prevention of low back pain in occupational settings. Occup Environ Med. 2012;69(1):1–2. doi: 10.1136/oemed-2011-100248.
    1. Steffens D, Maher CG, Pereira LM, et al. Prevention of low back pain: a systematic review and meta-analysis. JAMA Intern Med. 2016;176(2):199–208. doi: 10.1001/jamainternmed.2015.7431.
    1. Staal JB, Hlobil H, Twisk JW, Smid T, Koke AJ, van Mechelen W. Graded activity for low back pain in occupational health care: a randomized, controlled trial. Ann Intern Med. 2004;140(2):77–84. doi: 10.7326/0003-4819-140-2-200401200-00007.
    1. Anema JR, Steenstra IA, Bongers PM, de Vet HC, Knol DL, Loisel P, van Mechelen W. Multidisciplinary rehabilitation for subacute low back pain: graded activity or workplace intervention or both? A randomized controlled trial. Spine (Phila Pa 1976) 2007;32(3):291–298. doi: 10.1097/.
    1. Loisel P, Abenhaim L, Durand P, Esdaile JM, Suissa S, Gosselin L, Simard R, Turcotte J, Lemaire J. A population-based, randomized clinical trial on back pain management. Spine (Phila Pa 1976) 1997;22(24):2911–2918. doi: 10.1097/00007632-199712150-00014.
    1. Hlobil H, Uegaki K, Staal JB, de Bruyne MC, Smid T, van Mechelen W. Substantial sick-leave costs savings due to a graded activity intervention for workers with non-specific sub-acute low back pain. Eur Spine J. 2007;16(7):919–924. doi: 10.1007/s00586-006-0283-9.
    1. Lambeek LC, van Mechelen W, Knol DL, Loisel P, Anema JR. Randomised controlled trial of integrated care to reduce disability from chronic low back pain in working and private life. BMJ. 2010;340:c1035. doi: 10.1136/bmj.c1035.
    1. Geneen LJ, Moore R, Clarke C, Martin D, Colvin LA, Smith BH. Physical activity and exercise for chronic pain in adults: an overview of Cochrane reviews. Cochrane Database Syst Rev. 2017;(4):CD011279. 10.1002/14651858.CD011279.pub3.
    1. Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman J, van Tulder MW. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis. BMJ. 2015;350:h444.
    1. Karjalainen K, Malmivaara A, van Tulder M, Roine R, Jauhiainen M, Hurri H, Koes B. Multidisciplinary biopsychosocial rehabilitation for subacute low back pain among working age adults. Cochrane Database Syst Rev. 2008(3):CD002193.
    1. Suni J, Rinne M, Natri A, Statistisian MP, Parkkari J, Alaranta H. Control of the lumbar neutral zone decreases low back pain and improves self-evaluated work ability: a 12-month randomized controlled study. Spine (Phila Pa 1976) 2006;31(18):E611–E620. doi: 10.1097/01.brs.0000231701.76452.05.
    1. Rantonen J, Luoto S, Vehtari A, Hupli M, Karppinen J, Malmivaara A, Taimela S. The effectiveness of two active interventions compared to self-care advice in employees with non-acute low back symptoms: a randomised, controlled trial with a 4-year follow-up in the occupational health setting. Occup Environ Med. 2012;69(1):12–20. doi: 10.1136/oem.2009.054312.
    1. Rantonen J, Vehtari A, Karppinen J, Luoto S, Viikari-Juntura E, Hupli M, Malmivaara A, Taimela S. Face-to-face information combined with a booklet versus a booklet alone for treatment of mild low-back pain: a randomized controlled trial. Scand J Work Environ Health. 2014;40(2):156–166. doi: 10.5271/sjweh.3398.
    1. Burton AK, Waddell G, Tillotson KM, Summerton N. Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care. Spine. 1999;24(23):2484–2491. doi: 10.1097/00007632-199912010-00010.
    1. WHO . 10th revision. Geneva: World Health Organization; 2003. International statistical classification of diseases and related health problems (ICD-10)
    1. Stratford PW, Binkley JM. Measurement properties of the RM-18. A modified version of the Roland- Morris disability scale. Spine. 1997;22(20):2416–2421. doi: 10.1097/00007632-199710150-00018.
    1. Jordan K, Dunn KM, Lewis M, Croft P. A minimal clinically important difference was derived for the Roland-Morris disability questionnaire for low back pain. J Clin Epidemiol. 2006;59(1):45–52. doi: 10.1016/j.jclinepi.2005.03.018.
    1. Million R, Hall W, Nilsen KH, Baker RD, Jayson MI. Assessment of the progress of the back-pain patient 1981 Volvo award in clinical science. Spine. 1982;7(3):204–212. doi: 10.1097/00007632-198205000-00004.
    1. Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: visual analog scale for pain (VAS pain), numeric rating scale for pain (NRS pain), McGill pain questionnaire (MPQ), short-form McGill pain questionnaire (SF-MPQ), chronic pain grade scale (CPGS), short Form-36 bodily pain scale (SF-36 BPS), and measure of intermittent and constant osteoarthritis pain (ICOAP) Arthritis Care Res (Hoboken) 2011;63(Suppl 11):S240–S252. doi: 10.1002/acr.20543.
    1. Sintonen H. The 15D instrument of health-related quality of life: properties and applications. Ann Med. 2001;33(5):328–336. doi: 10.3109/07853890109002086.
    1. Niemisto L, Rissanen P, Sarna S, Lahtinen-Suopanki T, Lindgren KA, Hurri H. Cost-effectiveness of combined manipulation, stabilizing exercises, and physician consultation compared to physician consultation alone for chronic low back pain: a prospective randomized trial with 2-year follow-up. Spine (Phila Pa 1976) 2005;30(10):1109–1115. doi: 10.1097/01.brs.0000162569.00685.7b.
    1. Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980;66(8):271–273.
    1. Roland M, Fairbank J. The Roland-Morris disability questionnaire and the Oswestry disability questionnaire. Spine. 2000;25(24):3115–3124. doi: 10.1097/00007632-200012150-00006.
    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(2):157–168. doi: 10.1016/0304-3959(93)90127-B.
    1. Wertli MM, Rasmussen-Barr E, Held U, Weiser S, Bachmann LM, Brunner F. Fear-avoidance beliefs—a moderator of treatment efficacy in patients with low back pain: a systematic review. Spine J. 2014;14(11):2658–2678. doi: 10.1016/j.spinee.2014.02.033.
    1. Wertli MM, Rasmussen-Barr E, Weiser S, Bachmann LM, Brunner F. The role of fear avoidance beliefs as a prognostic factor for outcome in patients with nonspecific low back pain: a systematic review. Spine J. 2014;14(5):816–836.e814. doi: 10.1016/j.spinee.2013.09.036.
    1. Burton A, Billingham LJ, Bryan S. Cost-effectiveness in clinical trials: using multiple imputation to deal with incomplete cost data. Clin Trials. 2007;4(2):154–161. doi: 10.1177/1740774507076914.
    1. Ellis PD. The essential guide to effect sizes: statistical power, meta-analysis, and the interpretation of research results. New York: Cambridge University Press; 2010.
    1. Marmot M, Feeney A, Shipley M, North F, Syme SL. Sickness absence as a measure of health status and functioning: from the UK Whitehall II study. J Epidemiol Community Health. 1995;49(2):124–130. doi: 10.1136/jech.49.2.124.
    1. Kivimaki M, Head J, Ferrie JE, Shipley MJ, Vahtera J, Marmot MG. Sickness absence as a global measure of health: evidence from mortality in the Whitehall II prospective cohort study. BMJ. 2003;327(7411):364. doi: 10.1136/bmj.327.7411.364.
    1. Thorsen ST, Friborg C, Lundstrøm B, Kausto J, Örnelius K, Sundell T, Kalstø Å, Thune O, Gross B-O, Petersen H, et al. Sickness absence in the Nordic countries. Copenhagen: Nordic Social Statistical Committee; 2015.
    1. Spratt M, Carpenter J, Sterne JAC, Carlin JB, Heron J, Henderson J, Tilling K. Strategies for multiple imputation in longitudinal studies. Am J Epidemiol. 2010;172(4):478–487. doi: 10.1093/aje/kwq137.
    1. Sterne JAC, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, Wood AM, Carpenter JR. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. The BMJ. 2009;338:b2393. doi: 10.1136/bmj.b2393.
    1. Lamb SE, Hansen Z, Lall R, Castelnuovo E, Withers EJ, Nichols V, Potter R, Underwood MR. Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis. Lancet. 2010;375(9718):916–923. doi: 10.1016/S0140-6736(09)62164-4.
    1. Jellema P, van der Roer N, van der Windt DA, van Tulder MW, van der Horst HE, Stalman WA, Bouter LM. Low back pain in general practice: cost-effectiveness of a minimal psychosocial intervention versus usual care. Eur Spine J. 2007;16(11):1812–1821. doi: 10.1007/s00586-007-0439-2.
    1. Steenstra IA, Anema JR, Bongers PM, de Vet HC, Knol DL, van Mechelen W. The effectiveness of graded activity for low back pain in occupational healthcare. Occup Environ Med. 2006;63(11):718–725. doi: 10.1136/oem.2005.021675.
    1. Lamb SE, Lall R, Hansen Z, Castelnuovo E, Withers EJ, Nichols V, Griffiths F, Potter R, Szczepura A, Underwood M. A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain. The back skills training (BeST) trial. Health Technol Assess. 2010;14(41):1–253. doi: 10.3310/hta14410.
    1. Hay EM, Dunn KM, Hill JC, Lewis M, Mason EE, Konstantinou K, Sowden G, Somerville S, Vohora K, Whitehurst D, et al. A randomised clinical trial of subgrouping and targeted treatment for low back pain compared with best current care. The STarT back trial study protocol. BMC Musculoskelet Disord. 2008;9:58. doi: 10.1186/1471-2474-9-58.
    1. Hill JC, Whitehurst DGT, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, et al. Comparison of stratified primary care management for low back pain with current best practice (STarT back): a randomised controlled trial. Lancet. 2011;378(9802):1560–1571. doi: 10.1016/S0140-6736(11)60937-9.
    1. Rantonen J, Karppinen J, Vehtari A, Luoto S, Viikari-Juntura E, Hupli M, Malmivaara A, Taimela S. Cost-effectiveness of providing patients with information on managing mild low-back symptoms in an occupational health setting. BMC Public Health. 2016;16(1):316. doi: 10.1186/s12889-016-2974-4.
    1. Liddle SD, Gracey JH, Baxter GD. Advice for the management of low back pain: a systematic review of randomised controlled trials. Man Ther. 2007;12(4):310–327. doi: 10.1016/j.math.2006.12.009.
    1. Rolli Salathé C, Melloh M, Mannion AF, Tamcan Ö, Müller U, Boos N, Elfering A. Resources for preventing sickness absence due to low back pain. Occup Med. 2012;62(4):273–280. doi: 10.1093/occmed/kqs024.
    1. van Oostrom SH, Driessen MT, de Vet HC, Franche RL, Schonstein E, Loisel P, van Mechelen W, Anema JR. Workplace interventions for preventing work disability. Cochrane Database Syst Rev. 2009;(2):CD006955.
    1. Haukka E. Musculoskeletal disorders and psychosocial factors at work. Effects of a participatory ergonomics intervention in a cluster randomized controlled trial. Helsinki: University of Helsinki; 2010.
    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(4):277–285. doi: 10.1136/oem.2009.047548.
    1. Kaaria S, Luukkonen R, Riihimaki H, Kirjonen J, Leino-Arjas P. Persistence of low back pain reporting among a cohort of employees in a metal corporation: a study with 5-, 10-, and 28-year follow-ups. Pain. 2006;120(1–2):131–137. doi: 10.1016/j.pain.2005.10.020.
    1. Hall AM, Maher CG, Latimer J, Ferreira ML, Costa LO. The patient-specific functional scale is more responsive than the Roland Morris disability questionnaire when activity limitation is low. Eur Spine J. 2011;20(1):79–86. doi: 10.1007/s00586-010-1521-8.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner