title: Effectiveness and cost-effectiveness of rehabilitation after lumbar disc surgery (REALISE): design of a randomised controlled trial.
abstract: BACKGROUND
  Patients who undergo lumbar disc surgery for herniated discs, are advocated two different postoperative management strategies: a watchful waiting policy, or referral for rehabilitation immediately after discharge from the hospital. A direct comparison of the effectiveness and cost-effectiveness of these two strategies is lacking.
  
  
  METHODS
  A randomised controlled trial will be conducted with an economic evaluation alongside to assess the (cost-) effectiveness of rehabilitation after lumbar disc surgery. Two hundred patients aged 18-70 years with a clear indication for lumbar disc surgery of a single level herniated disc will be recruited and randomly assigned to either a watchful waiting policy for first six weeks or exercise therapy starting immediately after discharge from the hospital. Exercise therapy will focus on resumption of activities of daily living and return to work. Therapists will tailor the intervention to the individual patient's needs. All patients will be followed up by the neurosurgeon six weeks postoperatively. Main outcome measures are: functional status, pain intensity and global perceived recovery. Questionnaires will be completed preoperatively and at 3, 6, 9, 12 and 26 weeks after surgery. Data will be analysed according to the intention-to-treat principle, using a linear mixed model for continuous outcomes and a generalised mixed model for dichotomous outcomes. The economic evaluation will be performed from a societal perspective.
  
  
  CONCLUSIONS
  The results of this trial may lead to a more consistent postoperative strategy for patients who will undergo lumbar disc surgery.
  
  
  BACKGROUND
  Netherlands Trial Register: NTR3156.
authors.affiliation: Department of Health Sciences, Faculty of Earth and Life Science, VU University Amsterdam and the EMGO Institute for Health and Care Research, Amsterdam, The Netherlands. t.oosterhuis@vu.nl
authors.forename: Teddy
authors.initials: T
authors.lastname: Oosterhuis
authors.forename: Maurits
authors.initials: M
authors.lastname: van Tulder
authors.forename: Wilco
authors.initials: W
authors.lastname: Peul
authors.forename: Judith
authors.initials: J
authors.lastname: Bosmans
authors.forename: Carmen
authors.initials: C
authors.lastname: Vleggeert-Lankamp
authors.forename: Lidwien
authors.initials: L
authors.lastname: Smakman
authors.forename: Mark
authors.initials: M
authors.lastname: Arts
authors.forename: Raymond
authors.initials: R
authors.lastname: Ostelo
mesh_terms: D003362:Cost-Benefit Analysis; D005500:Follow-Up Studies; D006801:Humans; D007403:Intervertebral Disc / Q000473:pathology / Q000601:surgery; D007405:Intervertebral Disc Displacement / Q000191:economics* / Q000601:surgery*; D008159:Lumbar Vertebrae / Q000473:pathology / Q000601:surgery*; D016037:Single-Blind Method; D016896:Treatment Outcome
references.citation: BMJ. 2007 Jun 23;334(7607):1313-7
references.pmid: 17585160
references.citation: N Engl J Med. 2007 May 31;356(22):2245-56
references.pmid: 17538084
references.citation: Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4
references.pmid: 15928561
references.citation: Spine (Phila Pa 1976). 1994 Jun 1;19(11):1201-6
references.pmid: 8073310
references.citation: Expert Rev Pharmacoecon Outcomes Res. 2005 Feb;5(1):23-8
references.pmid: 19807557
references.citation: Clin J Pain. 2008 May;24(4):305-15
references.pmid: 18427229
references.citation: Ann Rheum Dis. 1978 Aug;37(4):378-81
references.pmid: 686873
references.citation: Spine (Phila Pa 1976). 2008 Apr 20;33(9):931-9
references.pmid: 18427312
references.citation: Spine (Phila Pa 1976). 1994 Oct 1;19(19):2139-43
references.pmid: 7809744
references.citation: Pain. 1993 Feb;52(2):157-168
references.pmid: 8455963
references.citation: Pain. 1999 Mar;80(1-2):329-39
references.pmid: 10204746
references.citation: Eur Spine J. 2006 May;15(5):527-36
references.pmid: 15915334
references.citation: Int J Behav Med. 2003;10(4):343-63
references.pmid: 14734263
references.citation: Spine (Phila Pa 1976). 2011 Oct 1;36(21):1807-14
references.pmid: 21505377
references.citation: Spine (Phila Pa 1976). 2000 Dec 15;25(24):3100-3
references.pmid: 11124724
references.citation: Eur J Phys Rehabil Med. 2010 Dec;46(4):497-503
references.pmid: 20639806
references.citation: BMC Musculoskelet Disord. 2006 May 31;7:47
references.pmid: 16737522
references.citation: Ned Tijdschr Geneeskd. 2005 Jul 9;149(28):1574-8
references.pmid: 16038162
references.citation: Clin J Pain. 1998 Sep;14(3):209-15
references.pmid: 9758070
references.citation: JAMA. 2009 Jul 8;302(2):149-58
references.pmid: 19584344
references.citation: J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86
references.pmid: 11132119
references.citation: Spine (Phila Pa 1976). 2006 Nov 15;31(24):E890-7
references.pmid: 17108817
references.citation: Clin J Pain. 2003 Mar-Apr;19(2):80-6
references.pmid: 12616177
references.citation: Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952
references.pmid: 11074683
references.citation: Spine (Phila Pa 1976). 2006 Nov 1;31(23):2707-14
references.pmid: 17077740
references.citation: N Engl J Med. 1999 Feb 11;340(6):418-23
references.pmid: 9971865
references.citation: Eur Spine J. 2005 Dec;14(10):1000-7
references.pmid: 15843969
references.citation: JAMA. 2006 Nov 22;296(20):2441-50
references.pmid: 17119140
references.citation: Cochrane Database Syst Rev. 2008 Oct 08;(4):CD003007
references.pmid: 18843637
references.citation: Spine (Phila Pa 1976). 2008 Jul 1;33(15):E494-500
references.pmid: 18594447
references.citation: J Neurosurg Spine. 2008 Jul;9(1):32-9
references.pmid: 18590408
references.citation: J Health Econ. 1995 Jun;14(2):171-89
references.pmid: 10154656
references.citation: Health Policy. 1990 Dec;16(3):199-208
references.pmid: 10109801
references.citation: Spine (Phila Pa 1976). 1996 Dec 15;21(24 Suppl):75S-78S
references.pmid: 9112328
references.citation: Spine (Phila Pa 1976). 2010 Feb 15;35(4):447-52
references.pmid: 20110835
references.citation: Eur Spine J. 2007 Jun;16(6):795-802
references.pmid: 16944223
references.citation: Med Care. 1995 Apr;33(4 Suppl):AS264-79
references.pmid: 7723455
references.citation: Spine (Phila Pa 1976). 2003 Aug 1;28(15):1739-45
references.pmid: 12897502
references.citation: Spine (Phila Pa 1976). 2008 Sep 1;33(19):2028-33
references.pmid: 18758356