The effect of graded activity and pain education (GAPE): an early post-surgical rehabilitation programme after lumbar spinal fusion-study protocol for a randomized controlled trial

Heidi Tegner, Bente Appel Esbensen, Marius Henriksen, Rachid Bech-Azeddine, Mari Lundberg, Louise Nielsen, Nanna Rolving, Heidi Tegner, Bente Appel Esbensen, Marius Henriksen, Rachid Bech-Azeddine, Mari Lundberg, Louise Nielsen, Nanna Rolving

Abstract

Background: Patients with chronic low back pain undergoing lumbar spinal fusion (LSF) are physically inactive and thereby at risk of poor health. Barriers to being physically active need to be acknowledged in post-surgical rehabilitation. The primary objective of this randomized controlled trial (RCT) is to examine the effect of an early active intervention consisting of graded activity and pain education (GAPE) on sedentary behaviour in a population of patients undergoing LSF. The secondary objective is to examine the effect of GAPE on disability, pain, fear of movement, self-efficacy for exercise, and health-related quality of life.

Methods: The study is an RCT planned to include 144 patients undergoing LSF at 1-2 levels for low back pain caused by degeneration of the lumbar spine. The patients will be randomly assigned to receive either usual care or usual care plus GAPE. GAPE consists of nine individual physiotherapist-guided sessions over a 10-week period. The overall purpose is to reduce sedentary behaviour, by educating the patient about pain and, based on a cognitive behavioural perspective, gradually strengthen the patient's self-efficacy to be physically active and reduce fear of movement. The physiotherapist will plan the intervention in collaboration with the patient. Based on a semi-structured interview and observations of the patient in their home, they will set individually functional goals. The primary outcome will be a reduction in sedentary behaviour, measured by an accelerometer at baseline (pre-surgery) and at 3 and 12 months post-surgery. Secondary outcomes will include disability, pain, fear of movement, self-efficacy for exercise, and quality of life. Secondary outcome data will be collected at baseline (pre-surgery) and at 3, 6 and 12 months post-surgery.

Discussion: We hypothesize that, compared with the "usual care group", GAPE will primarily lead to a significant reduction in sedentary behaviour, and secondarily a reduction in disability, pain intensity, and fear of movement; further, it will increase the patient's self-efficacy for exercise and quality of life.

Trial registration: www.clinicaltrials.gov NCT04103970 , Registered on 24 September 2019.

Keywords: Behaviour; Low back pain; Rehabilitation; Surgery.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
SPIRIT diagram for trial stages of enrolment, intervention, and assessment
Fig. 2
Fig. 2
Overview of the two study groups, intervention group and control group
Fig. 3
Fig. 3
Modified version of the fear-avoidance model [33, 34]
Fig. 4
Fig. 4
SENS accelerometer
Fig. 5
Fig. 5
Flow diagram including participant timeline

References

    1. GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1545–602.
    1. Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018;27(Suppl 6):796–801.
    1. Brook MI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in lumbar fusion procedure rates and associated hospital costs for degenerative spinal diseases in the United States, 2004 to 2015. Spine. 2019;44(5):369–376.
    1. Provaggi E, Capelli C, Leong JJH, Kalaskar DM. A UK-based pilot study of current surgical practice and implant preferences in lumbar fusion surgery. Medicine. 2018;97(26):e11169.
    1. Lotzke H, Jakobsson M, Gutke A, Hagstromer M, Brisby H, Hagg O, et al. Patients with severe low back pain exhibit a low level of physical activity before lumbar fusion surgery: a cross-sectional study. BMC Musculoskelet Disord. 2018;19(1):365.
    1. Jakobsson M, Brisby H, Gutke A, Hagg O, Lotzke H, Smeets R, et al. Prediction of objectively measured physical activity and self-reported disability following lumbar fusion surgery. World Neurosurg. 2019;121:e77–e88.
    1. Organization WH. Global recommendations on physical activity for health - global strategy on diet, physical activity and health. Switzerland: World Health Organization; 2010..
    1. Lundberg M, Larsson M, Ostlund H, Styf J. Kinesiophobia among patients with musculoskeletal pain in primary healthcare. J Rehabil Med. 2006;38(1):37–43.
    1. Archer KR, Phelps KD, Seebach CL, Song Y, Riley LH, 3rd, Wegener ST. Comparative study of short forms of the Tampa Scale for Kinesiophobia: fear of movement in a surgical spine population. Arch Phys Med Rehabil. 2012;93(8):1460–1462.
    1. Archer KR, Seebach CL, Mathis SL, Riley LH, 3rd, Wegener ST. Early postoperative fear of movement predicts pain, disability, and physical health six months after spinal surgery for degenerative conditions. Spine J. 2014;14(5):759–767.
    1. Archer KR, Wegener ST, Seebach C, Song Y, Skolasky RL, Thornton C, et al. The effect of fear of movement beliefs on pain and disability after surgery for lumbar and cervical degenerative conditions. Spine. 2011;36(19):1554–1562.
    1. Hasenbring MI, Plaas H, Fischbein B, Willburger R. The relationship between activity and pain in patients 6 months after lumbar disc surgery: do pain-related coping modes act as moderator variables? Eur J Pain. 2006;10(8):701–709.
    1. Seebach CL, Kirkhart M, Lating JM, Wegener ST, Song Y, Riley LH, 3rd, et al. Examining the role of positive and negative affect in recovery from spine surgery. Pain. 2012;153(3):518–525.
    1. Abbott AD, Hedlund R, Tyni-Lenne R. Patients’ experience post-lumbar fusion regarding back problems, recovery and expectations in terms of the international classification of functioning, disability and health. Disabil Rehabil. 2011;33(15–16):1399–1408.
    1. Abbott AD, Tyni-Lenne R, Hedlund R. Early rehabilitation targeting cognition, behavior, and motor function after lumbar fusion: a randomized controlled trial. Spine. 2010;35(8):848–857.
    1. Rolving N, Sogaard R, Nielsen CV, Christensen FB, Bunger C, Oestergaard LG. Preoperative cognitive-behavioral patient education versus standard care for lumbar spinal fusion patients: economic evaluation alongside a randomized controlled trial. Spine. 2016;41(1):18–25.
    1. Damsgaard JB, Jorgensen LB, Norlyk A, Birkelund R. Spinal fusion surgery: from relief to insecurity. Int J Orthop Trauma Nurs. 2017;24:31–39.
    1. Greenwood J, McGregor A, Jones F, Mullane J, Hurley M. Rehabilitation following lumbar fusion surgery: a systematic review and meta-analysis. Spine. 2016;41(1):E28–E36.
    1. Archer KR, Devin CJ, Vanston SW, Koyama T, Phillips SE, Mathis SL, et al. Cognitive-behavioral-based physical therapy for patients with chronic pain undergoing lumbar spine surgery: a randomized controlled trial. J Pain. 2016;17(1):76–89.
    1. Sanders SH. Operant conditioning with chronic pain: back to basics. In: Turk DC, Gatchel RJ, editors. Psychological approaches to pain management - a practitioner’s handbook. 2. New York: The Guilford Press; 2002. pp. 128–137.
    1. Bunzli S, Gillham D, Esterman A. Physiotherapy-provided operant conditioning in the management of low back pain disability: a systematic review. Physiother Res Int. 2011;16(1):4–19.
    1. Clarke CL, Ryan CG, Martin DJ. Pain neurophysiology education for the management of individuals with chronic low back pain: a systematic review and meta-analysis. Man Ther. 2011;16(6):544–549.
    1. Tegner H, Frederiksen P, Esbensen BA, Juhl C. Neurophysiological pain-education for patients with chronic low back pain – a systematic review and meta-analysis. Clin J Pain. 2018;34(8):778–786.
    1. Pires D, Cruz EB, Caeiro C. Aquatic exercise and pain neurophysiology education versus aquatic exercise alone for patients with chronic low back pain: a randomized controlled trial. Clin Rehabil. 2015;29(6):538–547.
    1. Malfliet A, Kregel J, Coppieters I, De Pauw R, Meeus M, Roussel N, et al. Effect of pain neuroscience education combined with cognition-targeted motor control training on chronic spinal pain: a randomized clinical trial. JAMA Neurol. 2018;75(7):808–817.
    1. Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain neurophysiology education and therapeutic exercise for patients with chronic low back pain: a single-blind randomized controlled trial. Arch Phys Med Rehabil. 2018;99(2):338–347.
    1. Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ (Clinical research ed) 2013;346:e7586.
    1. Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, et al. Degenerative lumbar spine disease: estimating global incidence and worldwide volume. Glob Spine J. 2018;8(8):784–794.
    1. SENS Motion [cited 2019. Available from: . Accessed 8 Sep 2020.
    1. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ (Clinical research ed) 2014;348:g1687.
    1. Turk DC. Cognitive-behavioral approach to the treatment of chronic pain patients. Reg Anesth Pain Med. 2003;28(6):573–579.
    1. Vlaeyen JW, Kole-Snijders AM, Boeren RG, van Eek H. Fear of movement/(re)injury in chronic low back pain and its relation to behavioral performance. Pain. 1995;62(3):363–372.
    1. Woby SR, Urmston M, Watson PJ. Self-efficacy mediates the relation between pain-related fear and outcome in chronic low back pain patients. Eur J Pain. 2007;11(7):711–718.
    1. Lundberg M. Kinesiophobia, various aspects of moving with musculoskeletal pain. Sweden: The Sahlgrenska Academy at Göteborg University; 2006.
    1. Fordyce WE. Behavioral methods for chronic pain and illness. Saint Louis: The C.V. Mosby Company; 1976. pp. 1–236.
    1. Leeuw M, Goossens ME, van Breukelen GJ, de Jong JR, Heuts PH, Smeets RJ, et al. Exposure in vivo versus operant graded activity in chronic low back pain patients: results of a randomized controlled trial. Pain. 2008;138(1):192–207.
    1. Verbunt JA, Seelen HA, Vlaeyen JW, van de Heijden GJ, Heuts PH, Pons K, et al. Disuse and deconditioning in chronic low back pain: concepts and hypotheses on contributing mechanisms. Eur J Pain. 2003;7(1):9–21.
    1. Kernan T, Rainville J. Observed outcomes associated with a quota-based exercise approach on measures of kinesiophobia in patients with chronic low back pain. J Orthop Sports Phys Ther. 2007;37(11):679–687.
    1. Fordyce WE. In: Fordyce’s behavioral methods for chronic pain and illness - republished with invited commentaries. Main CJ, Keefe FJ, Jensen MP, Vlaeyen JW, Vowles KE, editors. Philadelphia: IASP Press; 2015.
    1. Bovend’Eerdt TJ, Botell RE, Wade DT. Writing SMART rehabilitation goals and achieving goal attainment scaling: a practical guide. Clin Rehabil. 2009;23(4):352–361.
    1. Gatzounis R, Schrooten MG, Crombez G, Vlaeyen JW. Operant learning theory in pain and chronic pain rehabilitation. Curr Pain Headache Rep. 2012;16(2):117–126.
    1. Bekkering GE, Hendriks HJM, Koes BW, Oostendorp RAB, Ostelo RWJG, Thomassen JMCT, et al. Dutch physiotherapy guidelines for low back pain. Physiotherapy. 2003;89(2):82–96.
    1. Staehelin Jensen T, Dahl JB, Arendt-Nielsen L. Pain - background evidence treatment; Smerter - Baggrund Evidens Behandling. Copenhagen: FADL; 2013. p. 419.
    1. Louw A, Puentedura EJ, Zimney K, Schmidt S. Know pain, know gain? A perspective on pain neuroscience education in physical therapy. J Orthop Sports Phys Ther. 2016;46(3):131–134.
    1. Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O’Neal L, et al. The REDCap Consortium: building an international community of software platform partners. J Biomed Inform. 2019;95:103208.
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research Electronic Data Capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–381.
    1. Tremblay M. Letter to the editor: standardized use of the terms “sedentary” and “sedentary behaviours”. Appl Physiol Nutr Metab. 2012;37(3):540–2.
    1. Bartholdy C, Gudbergsen H, Bliddal H, Kjaergaard M, Lykkegaard KL, Henriksen M. Reliability and Construct Validity of the SENS Motion® activity measurement system as a tool to detect sedentary behaviour in patients with knee osteoarthritis. Arthritis. 2018;2018:6596278.
    1. Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine. 2000;25(22):2940–2952.
    1. Lauridsen HH, Hartvigsen J, Manniche C, Korsholm L, Grunnet-Nilsson N. Danish version of the Oswestry Disability Index for patients with low back pain. Part 1: Cross-cultural adaptation, reliability and validity in two different populations. Eur Spine J. 2006;15(11):1705–1716.
    1. Lauridsen HH, Hartvigsen J, Manniche C, Korsholm L, Grunnet-Nilsson N. Danish version of the Oswestry Disability Index for patients with low back pain. Part 2: Sensitivity, specificity and clinically significant improvement in two low back pain populations. Eur Spine J. 2006;15(11):1717–1728.
    1. Schwind J, Learman K, O’Halloran B, Showalter C, Cook C. Different minimally important clinical difference (MCID) scores lead to different clinical prediction rules for the Oswestry Disability Index for the same sample of patients. J Man Manip Ther. 2013;21(2):71–78.
    1. Maribo T. Vurdering af Visuel Analog Skala (VAS) [visual analouge scale] til vurdering af smerteintensitet - Niveau 2. København K: Danske Fysioterapeuter; 2005.
    1. Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983;16(1):87–101.
    1. Hapidou EG, O’Brien MA, Pierrynowski MR, de Las HE, Patel M, Patla T. Fear and avoidance of movement in people with chronic pain: psychometric properties of the 11-item Tampa Scale for Kinesiophobia (TSK-11) Physiother Can. 2012;64(3):235–241.
    1. Brooks R. EuroQol: the current state of play. Health policy (Amsterdam, Netherlands) 1996;37(1):53–72.
    1. Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33(5):337–343.
    1. Wittrup-Jensen KU, Lauridsen J, Gudex C, Pedersen KM. Generation of a Danish TTO value set for EQ-5D health states. Scand J Public Health. 2009;37(5):459–466.
    1. Sorensen J, Davidsen M, Gudex C, Pedersen KM, Bronnum-Hansen H. Danish EQ-5D population norms. Scand J Public Health. 2009;37(5):467–474.
    1. Rydwik E, Hovmoller F, Bostrom C. Aspects of reliability and validity of the Swedish version of the Self-Efficacy for Exercise Scale for older people. Physiother Theory Pract. 2014;30(2):131–137.
    1. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373–383.
    1. Huang YQ, Gou R, Diao YS, Yin QH, Fan WX, Liang YP, et al. Charlson comorbidity index helps predict the risk of mortality for patients with type 2 diabetic nephropathy. J Zhejiang Univ Sci B. 2014;15(1):58–66.
    1. Bartholdy C, Christensen R, Kristensen LE, Gudbergsen H, Bliddal H, Overgaard A, et al. Association between weight loss and spontaneous changes in physical inactivity in overweight/obese individuals with knee osteoarthritis: an 8-week prospective cohort study. Arthritis Care Res. 2019;3:397–404.
    1. Appendix 1 Guidelines for remuneration or other benefits for volunteers (danish); Appendix 1 - Retningslinjer for vederlag eller andre ydelser til frivillige forsøgspersoner: National Videnskabsetisk Komite; 2011. Available from: . Accessed 8 Sep 2020.
    1. Main CJ, Foster N, Buchbinder R. How important are back pain beliefs and expectations for satisfactory recovery from back pain? Best Pract Res Clin Rheumatol. 2010;24(2):205–217.
    1. Brunner E, De Herdt A, Minguet P, Baldew SS, Probst M. Can cognitive behavioural therapy based strategies be integrated into physiotherapy for the prevention of chronic low back pain? A systematic review. Disabil Rehabil. 2013;35(1):1–10.
    1. Cerin E, Cain KL, Oyeyemi AL, Owen N, Conway TL, Cochrane T, et al. Correlates of agreement between accelerometry and self-reported physical activity. Med Sci Sports Exerc. 2016;48(6):1075–1084.
    1. Prince SA, Adamo KB, Hamel ME, Hardt J, Connor Gorber S, Tremblay M. A comparison of direct versus self-report measures for assessing physical activity in adults: a systematic review. Int J Behav Nutr Phys Act. 2008;5:56.
    1. University of Copenhagen - Code for Authorship University of Copenhagen: University of Copenhagen; 2017 [the Practice Committee:[2]. Available from: . Accessed 8 Sep 2020.

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