Randomized controlled trial of postoperative exercise rehabilitation program after lumbar spine fusion: study protocol

Sami Tarnanen, Marko H Neva, Joost Dekker, Keijo Häkkinen, Kimmo Vihtonen, Liisa Pekkanen, Arja Häkkinen, Sami Tarnanen, Marko H Neva, Joost Dekker, Keijo Häkkinen, Kimmo Vihtonen, Liisa Pekkanen, Arja Häkkinen

Abstract

Background: Lumbar spine fusion (LSF) effectively decreases pain and disability in specific spinal disorders; however, the disability rate following surgery remains high. This, combined with the fact that in Western countries the number of LSF surgeries is increasing rapidly it is important to develop rehabilitation interventions that improve outcomes.

Methods/design: In the present RCT-study we aim to assess the effectiveness of a combined back-specific and aerobic exercise intervention for patients after LSF surgery. One hundred patients will be randomly allocated to a 12-month exercise intervention arm or a usual care arm. The exercise intervention will start three months after surgery and consist of six individual guidance sessions with a physiotherapist and a home-based exercise program. The primary outcome measures are low back pain, lower extremity pain, disability and quality of life. Secondary outcomes are back function and kinesiophobia. Exercise adherence will also be evaluated. The outcome measurements will be assessed at baseline (3 months postoperatively), at the end of the exercise intervention period (15 months postoperatively), and after a 1-year follow-up.

Discussion: The present RCT will evaluate the effectiveness of a long-term rehabilitation program after LSF. To our knowledge this will be the first study to evaluate a combination of strength training, control of the neutral lumbar spine position and aerobic training principles in rehabilitation after LSF.

Trial registration: ClinicalTrials.gov Identifier NCT00834015.

Figures

Figure 1
Figure 1
Flowchart of the study.

References

    1. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. Spinal fusion in the United States: analysis of trends from 1998 to 2008. Spine (Phila Pa 1976) 2012;37(1):67–76. doi: 10.1097/BRS.0b013e31820cccfb.
    1. Deyo RA, Gray DT, Kreuter W, Mirza S, Martin BI. United States trends in lumbar fusion surgery for degenerative conditions. Spine (Phila Pa 1976) 2005;30(12):1441–5. doi: 10.1097/01.brs.0000166503.37969.8a.
    1. Moller H, Hedlund R. Surgery versus conservative management in adult isthmic spondylolisthesis--a prospective randomized study: part 1. Spine (Phila Pa 1976) 2000;25(13):1711–1715. doi: 10.1097/00007632-200007010-00016.
    1. Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007;356(22):2257–2270. doi: 10.1056/NEJMoa070302.
    1. Maghout Juratli S, Franklin GM, Mirza SK, Wickizer TM, Fulton-Kehoe D. Lumbar fusion outcomes in Washington State workers' compensation. Spine (Phila Pa 1976) 2006;31(23):2715–2723. doi: 10.1097/01.brs.0000244589.13674.11.
    1. Abbott A, Tyni-Lenne R, Hedlund R. Early rehabilitation targeting cognition, behavior, and motor function after lumbar fusion: a randomized controlled trial. Spine (Phila Pa 1976) 2010;35(8):848–857. doi: 10.1097/BRS.0b013e3181d1049f.
    1. Christensen FB, Laurberg I, Bunger CE. Importance of the back-cafe concept to rehabilitation after lumbar spinal fusion: a randomized clinical study with a 2-year follow-up. Spine (Phila Pa 1976) 2003;28(23):2561–2569. doi: 10.1097/01.BRS.0000097890.96524.A1.
    1. Nielsen PR, Andreasen J, Asmussen M, Tonnesen H. Costs and quality of life for prehabilitation and early rehabilitation after surgery of the lumbar spine. BMC Health Serv Res. 2008;8:209. doi: 10.1186/1472-6963-8-209.
    1. Nielsen PR, Jorgensen LD, Dahl B, Pedersen T, Tonnesen H. Prehabilitation and early rehabilitation after spinal surgery: randomized clinical trial. Clin Rehabil. 2010;24(2):137–148. doi: 10.1177/0269215509347432.
    1. van Dieen JH, Selen LP, Cholewicki J. Trunk muscle activation in low-back pain patients, an analysis of the literature. J Electromyogr Kinesiol. 2003;13(4):333–351. doi: 10.1016/S1050-6411(03)00041-5.
    1. Danneels LA, Vanderstraeten GG, Cambier DC, Witvrouw EE, De Cuyper HJ. CT imaging of trunk muscles in chronic low back pain patients and healthy control subjects. Eur Spine J. 2000;9(4):266–272. doi: 10.1007/s005860000190.
    1. Smeets RJ, Wittink H, Hidding A, Knottnerus JA. Do patients with chronic low back pain have a lower level of aerobic fitness than healthy controls?: are pain, disability, fear of injury, working status, or level of leisure time activity associated with the difference in aerobic fitness level? Spine (Phila Pa 1976) 2006;31(1):90–7. doi: 10.1097/01.brs.0000192641.22003.83. discussion 98.
    1. Ekman P, Moller H, Shalabi A, Yu YX, Hedlund R. A prospective randomised study on the long-term effect of lumbar fusion on adjacent disc degeneration. Eur Spine J. 2009;18(8):1175–1186. doi: 10.1007/s00586-009-0947-3.
    1. Fan S, Hu Z, Zhao F, Zhao X, Huang Y, Fang X. Multifidus muscle changes and clinical effects of one-level posterior lumbar interbody fusion: minimally invasive procedure versus conventional open approach. Eur Spine J. 2010;19(2):316–324. doi: 10.1007/s00586-009-1191-6.
    1. Hyun SJ, Kim YB, Kim YS, Park SW, Nam TK, Hong HJ, Kwon JT. Postoperative changes in paraspinal muscle volume: comparison between paramedian interfascial and midline approaches for lumbar fusion. J Korean Med Sci. 2007;22(4):646–651. doi: 10.3346/jkms.2007.22.4.646.
    1. Motosuneya T, Asazuma T, Tsuji T, Watanabe H, Nakayama Y, Nemoto K. Postoperative change of the cross-sectional area of back musculature after 5 surgical procedures as assessed by magnetic resonance imaging. J Spinal Disord Tech. 2006;19(5):318–322. doi: 10.1097/01.bsd.0000211205.15997.06.
    1. Keller A, Brox JI, Gunderson R, Holm I, Friis A, Reikeras O. Trunk muscle strength, cross-sectional area, and density in patients with chronic low back pain randomized to lumbar fusion or cognitive intervention and exercises. Spine (Phila Pa 1976) 2004;29(1):3–8. doi: 10.1097/01.BRS.0000103946.26548.EB.
    1. Tiusanen H, Hurri H, Seitsalo S, Osterman K, Harju R. Functional and clinical results after anterior interbody lumbar fusion. Eur Spine J. 1996;5(5):288–292. doi: 10.1007/BF00304342.
    1. Tarnanen SP, Ylinen JJ, Siekkinen KM, Malkia EA, Kautiainen HJ, Hakkinen AH. Effect of isometric upper-extremity exercises on the activation of core stabilizing muscles. Arch Phys Med Rehabil. 2008;89(3):513–521. doi: 10.1016/j.apmr.2007.08.160.
    1. Tarnanen SP, Siekkinen KM, Hakkinen AH, Malkia EA, Kautiainen HJ, Ylinen JJ. Core Muscle Activation during Dynamic Upper Limb Exercises in Women. J Strength Cond Res. 2012. In press.
    1. Distefano LJ, Blackburn JT, Marshall SW, Padua DA. Gluteal muscle activation during common therapeutic exercises. J Orthop Sports Phys Ther. 2009;39(7):532–540.
    1. Ekstrom RA, Donatelli RA, Carp KC. Electromyographic analysis of core trunk, hip, and thigh muscles during 9 rehabilitation exercises. J Orthop Sports Phys Ther. 2007;37(12):754–762.
    1. Arokoski JP, Valta T, Airaksinen O, Kankaanpaa M. Back and abdominal muscle function during stabilization exercises. Arch Phys Med Rehabil. 2001;82(8):1089–1098. doi: 10.1053/apmr.2001.23819.
    1. Davidson KL, Hubley-Kozey CL. Trunk muscle responses to demands of an exercise progression to improve dynamic spinal stability. Arch Phys Med Rehabil. 2005;86(2):216–223. doi: 10.1016/j.apmr.2004.04.029.
    1. Akuthota V, Nadler SF. Core strengthening. Arch Phys Med Rehabil. 2004;85(3 Suppl 1):S86–92.
    1. McGill S. Low back disorders: evidence-based prevention and rehabilitation. 2. Human Kinetics, Champaign, IL; 2007. cop.
    1. Reiman MP. Trunk stabilization training: an evidence basis for the current state of affairs. J Back Musculoskelet Rehabil. 2009;22(3):131–142.
    1. Reiman MP, Weisbach PC, Glynn PE. The hips influence on low back pain: a distal link to a proximal problem. J Sport Rehabil. 2009;18(1):24–32.
    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):E611–20. doi: 10.1097/01.brs.0000231701.76452.05.
    1. Norris C, Matthews M. The role of an integrated back stability program in patients with chronic low back pain. Complement Ther Clin Pract. 2008;14(4):255–263. doi: 10.1016/j.ctcp.2008.06.001.
    1. Hillsdon M, Foster C, Thorogood M. Interventions for promoting physical activity. Cochrane Database Syst Rev. 2005;1(1):CD003180.
    1. Talanian JL, Galloway SD, Heigenhauser GJ, Bonen A, Spriet LL. Two weeks of high-intensity aerobic interval training increases the capacity for fat oxidation during exercise in women. J Appl Physiol. 2007;102(4):1439–1447.
    1. Nemoto K, Gen-no H, Masuki S, Okazaki K, Nose H. Effects of high-intensity interval walking training on physical fitness and blood pressure in middle-aged and older people. Mayo Clin Proc. 2007;82(7):803–811. doi: 10.4065/82.7.803.
    1. Tudor-Locke C, Hatano Y, Pangrazi RP, Kang M. Revisiting "how many steps are enough?". Med Sci Sports Exerc. 2008;40(7 Suppl):S537–43.
    1. Tudor-Locke C, Bassett DR. How many steps/day are enough? Preliminary pedometer indices for public health. Sports Med. 2004;34(1):1–8. doi: 10.2165/00007256-200434010-00001.
    1. Tudor-Locke C, Washington TL, Hart TL. Expected values for steps/day in special populations. Prev Med. 2009;49(1):3–11. doi: 10.1016/j.ypmed.2009.04.012.
    1. Åsenlöf P, Denison E, Lindberg P. Behavioral goal assessment in patients with persistent musculoskeletal pain. Physiother Theory Pract. 2004;20(4):243–254. doi: 10.1080/09593980490887957.
    1. Rhodes RE, Fiala B. Building motivation and sustainability into the prescription and recommendations for physical activity and exercise therapy: the evidence. Physiother Theory Pract. 2009;25(5–6):424–441.
    1. Jordan JL, Holden MA, Mason EJE, Foster NE. Interventions to improve adherence to exercise for chronic musculoskeletal pain in adults. Cochrane Database Syst Rev. 2010;1(1):CD005956.
    1. Leeuw M, Goossens ME, Linton SJ, Crombez G, Boersma K, Vlaeyen JW. The fear-avoidance model of musculoskeletal pain: current state of scientific evidence. J Behav Med. 2007;30(1):77–94. doi: 10.1007/s10865-006-9085-0.
    1. Dixon JS, Bird HA. Reproducibility along a 10 cm vertical visual analogue scale. Ann Rheum Dis. 1981;40(1):87–89. doi: 10.1136/ard.40.1.87.
    1. Pekkanen L, Kautiainen H, Ylinen J, Salo P, Hakkinen A. Reliability and validity study of the Finnish version 2.0 of the oswestry disability index. Spine (Phila Pa 1976) 2011;36(4):332–338.
    1. Aalto A. Rand 36-item health survey 1,0: suomenkielinen versio terveyteen liittyvän elämänlaadun kyselystä: kyselylomake ja käyttöohjeet. Stakes, Helsinki; 1995.
    1. Rantanen P, Airaksinen O, Penttinen E. Paradoxical variation of strength determinants with different rotation axes in trunk flexion and extension strength tests. Eur J Appl Physiol Occup Physiol. 1994;68(4):322–326. doi: 10.1007/BF00571451.
    1. Biering-Sorensen F. Physical measurements as risk indicators for low-back trouble over a one-year period. Spine (Phila Pa 1976) 1984;9(2):106–119. doi: 10.1097/00007632-198403000-00002.
    1. Latimer J, Maher CG, Refshauge K, Colaco I. The reliability and validity of the Biering-Sorensen test in asymptomatic subjects and subjects reporting current or previous nonspecific low back pain. Spine (Phila Pa 1976) 1999;24(20):2085–9. doi: 10.1097/00007632-199910150-00004. discussion 2090.
    1. Macrae IF, Wright V. Measurement of back movement. Ann Rheum Dis. 1969;28(6):584–589. doi: 10.1136/ard.28.6.584.
    1. Frost M, Stuckey S, Smalley LA, Dorman G. Reliability of measuring trunk motions in centimeters. Phys Ther. 1982;62(10):1431–1437.
    1. Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39(2):142–148.
    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. doi: 10.1016/0304-3959(94)00279-N.
    1. Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35(8):1381–1395. doi: 10.1249/01.MSS.0000078924.61453.FB.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner