Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2012

Open Access 01-12-2012 | Study protocol

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

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

Published in: BMC Musculoskeletal Disorders | Issue 1/2012

Login to get access

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
Appendix
Available only for authorised users
Literature
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. 10.1097/BRS.0b013e31820cccfb.CrossRef
2.
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. 10.1097/01.brs.0000166503.37969.8a.CrossRef
3.
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. 10.1097/00007632-200007010-00016.CrossRef
4.
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. 10.1056/NEJMoa070302.CrossRefPubMedPubMedCentral
5.
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. 10.1097/01.brs.0000244589.13674.11.CrossRef
6.
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. 10.1097/BRS.0b013e3181d1049f.CrossRef
7.
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. 10.1097/01.BRS.0000097890.96524.A1.CrossRef
8.
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: 209-10.1186/1472-6963-8-209.CrossRefPubMedPubMedCentral
9.
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. 10.1177/0269215509347432.CrossRefPubMed
10.
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. 10.1016/S1050-6411(03)00041-5.CrossRefPubMed
11.
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. 10.1007/s005860000190.CrossRefPubMedPubMedCentral
12.
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. 10.1097/01.brs.0000192641.22003.83. discussion 98CrossRef
13.
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. 10.1007/s00586-009-0947-3.CrossRefPubMedPubMedCentral
14.
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. 10.1007/s00586-009-1191-6.CrossRefPubMed
15.
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. 10.3346/jkms.2007.22.4.646.CrossRefPubMedPubMedCentral
16.
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. 10.1097/01.bsd.0000211205.15997.06.CrossRefPubMed
17.
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. 10.1097/01.BRS.0000103946.26548.EB.CrossRef
18.
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. 10.1007/BF00304342.CrossRefPubMed
19.
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. 10.1016/j.apmr.2007.08.160.CrossRefPubMed
20.
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
21.
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.CrossRefPubMed
22.
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.CrossRefPubMed
23.
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. 10.1053/apmr.2001.23819.CrossRefPubMed
24.
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. 10.1016/j.apmr.2004.04.029.CrossRefPubMed
25.
26.
McGill S: Low back disorders: evidence-based prevention and rehabilitation. 2007, Human Kinetics, Champaign, IL, cop, 2
27.
Reiman MP: Trunk stabilization training: an evidence basis for the current state of affairs. J Back Musculoskelet Rehabil. 2009, 22 (3): 131-142.PubMed
28.
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.PubMed
29.
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. 10.1097/01.brs.0000231701.76452.05.CrossRef
30.
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. 10.1016/j.ctcp.2008.06.001.CrossRefPubMed
31.
Hillsdon M, Foster C, Thorogood M: Interventions for promoting physical activity. Cochrane Database Syst Rev. 2005, 1 (1): CD003180-PubMed
32.
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.CrossRefPubMed
33.
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. 10.4065/82.7.803.CrossRefPubMed
34.
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.CrossRefPubMed
35.
Tudor-Locke C, Bassett DR: How many steps/day are enough? Preliminary pedometer indices for public health. Sports Med. 2004, 34 (1): 1-8. 10.2165/00007256-200434010-00001.CrossRefPubMed
36.
Tudor-Locke C, Washington TL, Hart TL: Expected values for steps/day in special populations. Prev Med. 2009, 49 (1): 3-11. 10.1016/j.ypmed.2009.04.012.CrossRefPubMed
37.
Åsenlöf P, Denison E, Lindberg P: Behavioral goal assessment in patients with persistent musculoskeletal pain. Physiother Theory Pract. 2004, 20 (4): 243-254. 10.1080/09593980490887957.CrossRef
38.
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.CrossRefPubMed
39.
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-PubMed
40.
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. 10.1007/s10865-006-9085-0.CrossRefPubMed
41.
42.
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.CrossRef
43.
Aalto A: Rand 36-item health survey 1,0: suomenkielinen versio terveyteen liittyvän elämänlaadun kyselystä: kyselylomake ja käyttöohjeet. 1995, Stakes, Helsinki
44.
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. 10.1007/BF00571451.CrossRefPubMed
45.
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. 10.1097/00007632-198403000-00002.CrossRef
46.
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. 10.1097/00007632-199910150-00004. discussion 2090CrossRef
47.
48.
Frost M, Stuckey S, Smalley LA, Dorman G: Reliability of measuring trunk motions in centimeters. Phys Ther. 1982, 62 (10): 1431-1437.PubMed
49.
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.CrossRefPubMed
50.
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. 10.1016/0304-3959(94)00279-N.CrossRefPubMed
51.
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. 10.1249/01.MSS.0000078924.61453.FB.CrossRefPubMed
Metadata
Title
Randomized controlled trial of postoperative exercise rehabilitation program after lumbar spine fusion: study protocol
Authors
Sami Tarnanen
Marko H Neva
Joost Dekker
Keijo Häkkinen
Kimmo Vihtonen
Liisa Pekkanen
Arja Häkkinen
Publication date
01-12-2012
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2012
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/1471-2474-13-123

Other articles of this Issue 1/2012

BMC Musculoskeletal Disorders 1/2012 Go to the issue

Research article

The impact of secondary hyperparathyroidism on the efficacy of antiresorptive therapy

Research article

Vertebral derotation in adolescent idiopathic scoliosis causes hypokyphosis of the thoracic spine

Research article

Rheumatoid arthritis and the incidence of influenza and influenza-related complications: a retrospective cohort study

Study protocol

Ferric carboxymaltose with or without erythropoietin for the prevention of red-cell transfusions in the perioperative period of osteoporotic hip fractures: a randomized contolled trial. The PAHFRAC-01 project

Research article

Hip resurfacing in a district general hospital: 6-year clinical results using the ReCap hip resurfacing system

Research article

Effects and predictors of shoulder muscle massage for patients with posterior shoulder tightness