Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial
Open accessAbstract
OBJECTIVES: To assess the clinical effectiveness of surgical stabilisation (spinal fusion) compared with intensive rehabilitation for patients with chronic low back pain. DESIGN: Multicentre randomised controlled trial. SETTING: 15 secondary care orthopaedic and rehabilitation centres across the United Kingdom. PARTICIPANTS: 349 participants aged 18-55 with chronic low back pain of at least one year's duration who were considered candidates for spinal fusion. INTERVENTION: Lumbar spine fusion or an intensive rehabilitation programme based on principles of cognitive behaviour therapy. MAIN OUTCOME MEASURE: The primary outcomes were the Oswestry disability index and the shuttle walking test measured at baseline and two years after randomisation. The SF-36 instrument was used as a secondary outcome measure. RESULTS: 176 participants were assigned to surgery and 173 to rehabilitation. 284 (81%) provided follow-up data at 24 months. The mean Oswestry disability index changed favourably from 46.5 (SD 14.6) to 34.0 (SD 21.1) in the surgery group and from 44.8 (SD14.8) to 36.1 (SD 20.6) in the rehabilitation group. The estimated mean difference between the groups was -4.1 (95% confidence interval -8.1 to -0.1, P = 0.045) in favour of surgery. No significant differences between the treatment groups were observed in the shuttle walking test or any of the other outcome measures. CONCLUSIONS: Both groups reported reductions in disability during two years of follow-up, possibly unrelated to the interventions. The statistical difference between treatment groups in one of the two primary outcome measures was marginal and only just reached the predefined minimal clinical difference, and the potential risk and additional cost of surgery also need to be considered. No clear evidence emerged that primary spinal fusion surgery was any more beneficial than intensive rehabilitation.
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Although trials do not tend to report adverse effects or deterioration, such effects should be small, so the treatment can be considered to be safe, with the reservation that reasons for discontinuing treatment are rarely given and may be due to hidden adverse effects.
“Although trials do not tend to report adverse effects or deterioration (such as worsening of depression to a level of clinical concern), we know that such effects should be small (Fairbank 2005;Hellum 2011;Morley 2008), so the treatment can be considered to be safe, with the reservation that the reasons for discontinuing treatment are rarely given and may be due to hidden adverse effects.”
From Psychological therapies for the management of chronic pain (excluding headache) in adults (2012) · cites this paper as Fairbank 2005
Treatment gains are of the same order as those of other available treatments, as shown by head-to-head trials of surgery versus psychologically based rehabilitation.
“Treatment gains are of the same order as those of other available treatments (Glombiewski 2010), as shown by head-to-head trials of surgery versus psychologically based rehabilitation (Fairbank 2005;Hellum 2011).”
From Psychological therapies for the management of chronic pain (excluding headache) in adults (2012) · cites this paper as Fairbank 2005
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“38 Lumbar spinal fusions, yet another surgical procedure performed to relieve chronic low back pain, have been the subject of several RCTs involving comparisons to nonsurgical therapies (Brox et al., 2003; Fairbank et al., 2005; Fritzell et al., 2004).”
BackgroundVidebæk, T. S., Christensen, F. B., Soegaard, R., Hansen, E. S., Høy, K., Helmig, P., Niedermann, B., Eiskjær, S. P., & Bünger, C. E. (2006) · Spine · doi:10.1097/01.brs.0000247793.99827.b7 · Cited by 148 · see citing works
Minimum acceptable outcomes after lumbar spinal fusion
Carragee, E. J., & Cheng, I. (2010) · The Spine Journal · doi:10.1016/j.spinee.2010.02.001 · Cited by 139 · see citing works
The Swedish Spine Register: development, design and utility
Swedish Society of Spinal Surgeons, Strömqvist, B., Fritzell, P., Hägg, O., & Jönsson, B. (2009) · European Spine Journal · doi:10.1007/s00586-009-1043-4 · Cited by 138 · see citing works
“For isthmic spondylolisthesis and DDD, RCTs comparing surgical and non-surgical treatment exist today [1, 4, 5, 14] and, although the results are to some extent conflicting, these diagnoses can be said to be exponents for evidence-based medicine, EBM.”
Lauridsen, H. H., Hartvigsen, J., Manniche, C., Korsholm, L., & Grunnet-Nilsson, N. (2006) · European Spine Journal · doi:10.1007/s00586-006-0117-9 · Cited by 137 · see citing works
“Thus, the mean pain and disability scores are lower compared to a purely surgical population such as those reported by Fairbank et al. [ 59 ] and Fritzell et al. [60].”
The role of physiotherapy in the management of non-specific back pain and neck pain
Moffett, J., & McLean, S. M. (2005) · Lara D. Veeken · doi:10.1093/rheumatology/kei242 · Cited by 135 · see citing works
“A recent large scale trial (n1⁄4 349) in the UK compared an intensive functional restoration programme with surgical spinal stabilization for chronic back pain patients [98, 99].”
BackgroundFour-year follow-up of surgical versus non-surgical therapy for chronic low back pain
Brox, J., Nygaard, O. P., Holm, I., Keller, A., Ingebrigtsen, T., & Reikerås, O. (2009) · Annals of the Rheumatic Diseases · doi:10.1136/ard.2009.108902 · Cited by 131 · see citing works
Hughes, S. P. F., Freemont, A. J., Hukins, D. W. L., McGregor, A. H., & Roberts, S. (2012) · Journal of Bone and Joint Surgery - British Volume · doi:10.1302/0301-620x.94b10.28986 · Cited by 130 · see citing works
Clarke, M. J., Hopewell, S., & Chalmers, L. (2007) · Journal of the Royal Society of Medicine · doi:10.1177/014107680710011415 · Cited by 145 · see citing works
Evidence-informed management of chronic low back pain with cognitive behavioral therapy
Gatchel, R. J., & Rollings, K. H. (2008) · The Spine Journal · doi:10.1016/j.spinee.2007.10.007 · Cited by 125 · see citing works
Outcome of invasive treatment modalities on back pain and sciatica: an evidence-based review
van Tulder, M. W., Koes, B., Seitsalo, S., & Malmivaara, A. (2006) · European Spine Journal · doi:10.1007/s00586-005-1049-5 · Cited by 124 · see citing works
“The European guidelines included a third trial [26].”
BackgroundMannion, A. F., Brox, J. I., & Fairbank, J. C. T. (2013) · The Spine Journal · doi:10.1016/j.spinee.2013.06.101 · Cited by 123 · see citing works
“The treatments administered in each of the studies have been described in detail for the respective trials (UK [9] and Norway [7,8]).”
BackgroundMethodResultInfluentialPrevention and management of chronic back pain
Weiner, S. S., & Nordin, M. (2010) · Best Practice & Research Clinical Rheumatology · doi:10.1016/j.berh.2009.12.001 · Cited by 119 · see citing works
Hellum, C., Johnsen, L. G., Storheim, K., Nygaard, O. P., Brox, J. I., Rossvoll, I., Ro, M., Sandvik, L., Grundnes, O., & and the Norwegian Spine Study Group (2011) · BMJ · doi:10.1136/bmj.d2786 · Cited by 116 · see citing works
Pettine, K. A., Suzuki, R. K., Sand, T. T., & Murphy, M. (2015) · International Orthopaedics · doi:10.1007/s00264-015-2886-4 · Cited by 115 · see citing works
The Role of Classification of Chronic Low Back Pain
Fairbank, J. C. T., Gwilym, S. E., France, J. C., Daffner, S. D., Dettori, J. R., Hermsmeyer, J., & Andersson, G. B. J. (2011) · Spine · doi:10.1097/brs.0b013e31822ef72c · Cited by 111 · see citing works
Genevay, S., Atlas, S. J., & Katz, J. N. (2010) · Spine · doi:10.1097/brs.0b013e3181bc9454 · Cited by 108 · see citing works
“Five related to clinical symptoms: (1) presence of accompanying back pain; (2) leg pain greater than back pain; (3) characteristic of leg pain (radicular/sciatic/dermatome distribution); (4) pattern of pain radiation (anterior thigh, below the knee); and (5) pain on Valsalva maneuver.”
BackgroundRolving, N., Nielsen, C. V., Christensen, F. B., Holm, R., Bünger, C. E., & Oestergaard, L. G. (2015) · Spine · doi:10.1097/brs.0000000000000843 · Cited by 105 · see citing works
Madera, M. A., Brady, J., Deily, S. E., McGinty, T., Moroz, L., Singh, D., Tipton, G. W., & Truumees, E. (2017) · Journal of Neurosurgery Spine · doi:10.3171/2016.10.spine16627 · Cited by 106 · see citing works
“10–13, 24,44,45,48,49 Several of these seminal papers compared outcomes of rehabilitation versus fusion surgery for degenerative disease.”
BackgroundLumbar Fusion Outcomes in Washington State Workers’ Compensation
Juratli, S. M., Franklin, G. M., Mirza, S. K., Wickizer, T. M., & Fulton‐Kehoe, D. (2006) · Spine · doi:10.1097/01.brs.0000244589.13674.11 · Cited by 105 · see citing works
“Among possible explanations for the persistently poor outcomes are: 1) the shift toward greater use of instrumentation and cages could have independently increased the complication and reoperation risk; 2) lumbar fusion may be performed on patients already disabled given the high prevalence of preoperative disability;…”
BackgroundEscala de incapacidad por dolor lumbar de Oswestry
Bumbiedro, S. A., Flórez-García, M. T., Pérez, C. E., & García-Pérez, F. (2006) · Rehabilitación · doi:10.1016/s0048-7120(06)74881-2 · Cited by 98 · see citing works
Reoperation Rates Following Instrumented Lumbar Spine Fusion
Irmola, T., HÄKKINEN, A. H., Järvenpää, S. K., Marttinen, I. H., Vihtonen, K., & Neva, M. H. (2017) · Spine · doi:10.1097/brs.0000000000002291 · Cited by 97 · see citing works
“The value of spinal fusion for the treatment of chronic low back pain is controversial [8-10].”
BackgroundStienen, M. N., Ho, A. L., Staartjes, V. E., Maldaner, N., Veeravagu, A., Desai, A. M., Gautschi, O. P., Bellut, D., Regli, L., Ratliff, J. K., et al. (2019) · The Spine Journal · doi:10.1016/j.spinee.2019.02.014 · Cited by 97 · see citing works
Faundez, A. A., Schwender, J. D., Safriel, Y. I., Gilbert, T. J., Mehbod, A. A., Denis, F., Transfeldt, E. E., & Wroblewski, J. M. (2009) · European Spine Journal · doi:10.1007/s00586-008-0845-0 · Cited by 95 · see citing works
“The goal of a fusion of the lumbar spine is to obtain a primary solid arthrodesis so as to alleviate pain [10, 11, 14, 15, 19, 22, 31].”
BackgroundFusion surgery for lumbar degenerative disc disease: still more questions than answers
Deyo, R. A. (2015) · The Spine Journal · doi:10.1016/j.spinee.2014.11.004 · Cited by 95 · see citing works
Fielding, S., MacLennan, G., Cook, J. A., & Ramsay, C. R. (2008) · Trials · doi:10.1186/1745-6215-9-51 · Cited by 93 · see citing works
“[31] employed multiple imputation using a regression model as part of a sensitivity analysis.”
Lumbar spine fusion: what is the evidence?
Harris, I. A., Traeger, A. C., Stanford, R., Maher, C. G., & Buchbinder, R. (2018) · Internal Medicine Journal · doi:10.1111/imj.14120 · Cited by 92 · see citing works
Reme, S. E., Sveinsdóttir, V. Ó., & Eriksen (2012) · Journal of Pain Research · doi:10.2147/jpr.s25330 · Cited by 91 · see citing works
“CBT principles have, for instance, been applied in a couple of studies involving psychoeducational treatment programs,(37,55) as well as in various rehabilitation programs.(70) The combination of CBT with other treatment components and interventions can further be divided in two”
Ibrahim, T., Tleyjeh, I. M., & Gabbar, O. (2006) · International Orthopaedics · doi:10.1007/s00264-006-0269-6 · Cited by 91 · see citing works
Ng, J., & Kitchen, N. D. (2008) · Journal of Neurology Neurosurgery & Psychiatry · doi:10.1136/jnnp.2007.117002 · Cited by 91 · see citing works
Surgery Versus Nonsurgical Treatment of Cervical Radiculopathy
Engquist, M., Löfgren, H., Öberg, B. E., Holtz, A., Peolsson, A. L. C., Söderlund, A., Vavruch, L., & Lind, B. I. (2013) · Spine · doi:10.1097/brs.0b013e31829ff095 · Cited by 90 · see citing works
“Employed; n (%) Sick leave (full- or part-time), n (%) Change of work due to neck problems, n (%) 33 (52) 17(28) 12 (20)”
Ferreira, M. L., Smeets, R., Kamper, S. J., Ferreira, P. H., & Machado, L. A. C. (2010) · Physical Therapy · doi:10.2522/ptj.20090332 · Cited by 90 · see citing works
Surgical Trial in Lobar Intracerebral Haemorrhage (STICH II) Protocol
the STICH II Investigators, Mendelow, A. D., GREGSON, B. A., Mitchell, P., Murray, G. D., Rowan, E. N., & Gholkar, A. R. (2011) · Trials · doi:10.1186/1745-6215-12-124 · Cited by 89 · see citing works
Ziébland, S., Featherstone, K., Snowdon, C., Barker, K. L., Frost, H., & Fairbank, J. T. (2007) · Trials · doi:10.1186/1745-6215-8-4 · Cited by 88 · see citing works
Operative Management of Lumbar Degenerative Disc Disease
Lee, Y. C., Zotti, M. G. T., & Osti, O. L. (2016) · Asian Spine Journal · doi:10.4184/asj.2016.10.4.801 · Cited by 86 · see citing works
“trials to support fusion surgery for pain relief in prevalent back pain with improvement in function in patients not responding to non-surgical treatments [41,42].”
BackgroundShirado, O., Doi, T., Akai, M., Hoshino, Y. Y., Fujino, K., Hayashi, K., Marui, E., & Iwaya, T. (2010) · Spine · doi:10.1097/brs.0b013e3181d7a4d2 · Cited by 85 · see citing works
Management of Degenerative Disk Disease and Chronic Low Back Pain
Karppinen, J. I., Shen, F. H., Luk, K. D. K., Andersson, G. B. J., Cheung, K., & Samartzis, D. (2011) · Orthopedic Clinics of North America · doi:10.1016/j.ocl.2011.07.009 · Cited by 84 · see citing works
“Moreover, based on the Medical Research Council Spine Stabilization RCT assessing patients with chronic LBP at a minimum of 1year duration who were randomized to undergo lumbar fusion or an intensive rehabilitation program based on cognitive behavioral principles, no difference in disability and functional outcomewasn…”
MethodMannion, A. F., Leivseth, G., Brox, J. I., Fritzell, P., Hägg, O., & Fairbank, J. C. T. (2014) · Spine · doi:10.1097/brs.0000000000000437 · Cited by 84 · see citing works
Levin, J. H. (2008) · The Spine Journal · doi:10.1016/j.spinee.2008.06.447 · Cited by 82 · see citing works
“045) and Oswestry Disability Index (31/20 vs. 33/28, p5.”
BackgroundSimons, C., Rivero‐Arias, O., Yu, L., & Simon, J. (2014) · Quality of Life Research · doi:10.1007/s11136-014-0837-y · Cited by 81 · see citing works
Rampersaud, Y. R., Ravi, B., Lewis, S. J., Stas, V., Barron, R., Davey, R., & Mahomed, N. M. (2007) · The Spine Journal · doi:10.1016/j.spinee.2007.05.003 · Cited by 80 · see citing works
Rationale for the Surgical Treatment of Lumbar Degenerative Spondylolisthesis
Schroeder, G. D., Kepler, C. K., Kurd, M. F., Vaccaro, A. R., Hsu, W. K., Patel, A. A., & Savage, J. W. (2015) · Spine · doi:10.1097/brs.0000000000001116 · Cited by 79 · see citing works
Circumferential Fusion Is Dominant Over Posterolateral Fusion in a Long-term Perspective
Soegaard, R., Bünger, C. E., Christiansen, T., Høy, K., Eiskjær, S. P., & Christensen, F. B. (2007) · Spine · doi:10.1097/brs.0b013e3181573b2d · Cited by 78 · see citing works
“trial were comparable to our study population with respect to age, gender, diagnosis, duration of symptoms, and the selected surgical technique for spinal fusion.(5)”
ResultRehabilitation Following Lumbar Fusion Surgery
Greenwood, J., McGregor, A. H., Jones, F., Mullane, J., & Hurley, M. (2015) · Spine · doi:10.1097/brs.0000000000001132 · Cited by 77 · see citing works
Idiopathic Scoliosis Treated With Cotrel-Dubousset Instrumentation
Bjerkreim, I., Steen, H., & Brox, J. I. (2007) · Spine · doi:10.1097/brs.0b013e318145a54a · Cited by 76 · see citing works
Willems, P. C. P. H. (2013) · Acta Orthopaedica · doi:10.3109/17453674.2012.753565 · Cited by 76 · see citing works
“several studies have reported that cognitive behavioural therapy or intensive exercise programs (brox et al. 2003; fairbank et al. 2005; guzman et al. 2001) have treatment results similar to those of spinal fusion, but with considerably less complications, morbidity and costs (fritzell et al.”
BackgroundResultInfluentialCan cost utility evaluations inform decision making about interventions for low back pain?
Dagenais, S., Roffey, D. M., Wai, E. K., Haldeman, S., & Jaime, J. (2009) · The Spine Journal · doi:10.1016/j.spinee.2009.07.007 · Cited by 77 · see citing works
“Several studies did not provide sufficient details and additional information had to be obtained from clinical reports [61–64].”
BackgroundAl-Kaisy, A. A., Palmisani, S., Smith, T. E., Pang, D. C., Lam, K. S., Burgoyne, W., Houghton, R., Hudson, E., & Lucas, J. D. (2016) · Neuromodulation Technology at the Neural Interface · doi:10.1111/ner.12563 · Cited by 75 · see citing works
Eck, J. C., Sharan, A. D., Ghogawala, Z., Resnick, D. K., Watters, W. C., Mummaneni, P. V., Dailey, A. T., Choudhri, T. F., Groff, M. W., Wang, J. C., et al. (2014) · Journal of Neurosurgery Spine · doi:10.3171/2014.4.spine14270 · Cited by 75 · see citing works
Dengler, J. (2017) · Pain Physician · doi:10.36076/ppj.20.5.537 · Cited by 75 · see citing works
The role of an integrated back stability program in patients with chronic low back pain
Norris, C. M., & Matthews, M. J. (2008) · Complementary Therapies in Clinical Practice · doi:10.1016/j.ctcp.2008.06.001 · Cited by 71 · see citing works
“Ia 11.5 (8.5) 11.1 (7.7) 0.886 10.5 (7) 3.6 (3.9) 0.000* 0.000* � 1.20 � 1.74 � 0.63 Ib 3.3 (4.1) 3.3 (3.6) 0.056 3.1 (2.3) 0.6 (0.9) 0.000* 0.000* � 0.99 � 1.52 � 0.44 Ia+b 14.8 ( 12 ) 14.3 (10.7) 0.834 13.4 (8.1) 4.1 (4.5) 0.000* 0.000* � 1.21 � 1.75 � 0.63 II 36.6 (35.7) 36.2 (34.6) 0.217 52.3 (26.6) 13.5 (11.8) 0.…”
InfluentialStem cell regeneration of degenerated intervertebral discs: Current status
Richardson, S. M., & Hoyland, J. A. (2008) · Current Pain and Headache Reports · doi:10.1007/s11916-008-0016-3 · Cited by 71 · see citing works
The long-term outcome of lumbar fusion in the Swedish lumbar spine study
Hedlund, R., Johansson, C., Hägg, O., Fritzell, P., & Tullberg, T. (2015) · The Spine Journal · doi:10.1016/j.spinee.2015.08.065 · Cited by 70 · see citing works
“In contrast, in British and Norwegian short-term as well as long-term studies, no statistically or clinically relevant difference could be demonstrated comparing fusion with physiotherapy and cognitive therapy [2–5].”
ResultThe influence of psychological interventions on surgical outcomes: a systematic review
Lanini, I., Amass, T. H., Calabrisotto, C. S., Fabbri, S., Falsini, S., Adembri, C., Filippo, A. D., Romagnoli, S., & Villa, G. (2022) · Journal of Anesthesia Analgesia and Critical Care · doi:10.1186/s44158-022-00057-4 · Cited by 69 · see citing works
Five-year follow-up of total disc replacement compared to fusion: a randomized controlled trial
Sköld, C., Tropp, H., & Berg, S. (2013) · European Spine Journal · doi:10.1007/s00586-013-2926-y · Cited by 68 · see citing works
Melloh, M., Röder, C., Elfering, A., Theis, J., Müller, U., Staub, L., Aghayev, E., Zweig, T., Barz, T., Kohlmann, T., et al. (2008) · BMC Musculoskeletal Disorders · doi:10.1186/1471-2474-9-81 · Cited by 68 · see citing works
Manchikanti, L. (2013) · Pain Physician · doi:10.36076/ppj.2013/16/se55 · Cited by 67 · see citing works
- Authors
- Fairbank, J., Frost, H., Wilson-MacDonald, J., Yu, L.-M., Barker, K., & Collins, R.
- Affiliations
- Nuffield Orthopaedic Centre (GB)
- University of Warwick (GB)
- University of Oxford (GB)
- Corresponding author
- Fairbank, Jeremy
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2005-05-23
- Volume
- 330
- Issue
- 7502
- Pages
- 1233
- ISSN
- 0007-1447 (ISSN-L)
- 0959-8138
- 1468-5833
- PMC
- PMC558090
- OpenAlex
- W2117632584
- Cited by
- 514
- References
- 43
- Citations by year
- 2026: 9 · 2025: 12 · 2024: 9 · 2023: 11 · 2022: 16 · 2021: 11 · 2020: 8 · 2019: 18 · 2018: 11 · 2017: 25 · 2016: 25 · 2015: 31 · 2014: 25 · 2013: 38 · 2012: 28
- FWCI
- 25.95
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- BMJ (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Edinburgh Napier Research Repository (Edinburgh Napier University) (submittedVersion, cc-by-nc)
- Stirling Online Research Repository (University of Stirling) (submittedVersion, cc-by-nc)
- Research Output (Edinburgh Napier University) (submittedVersion, cc-by)
- HighWire Press Open Archive (submittedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Health Sciences › Medicine › Pathology and Forensic Medicine › Spine and Intervertebral Disc Pathology
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Treatment
- Keywords
- chronic low back pain, lumbar fusion, spinal stabilization, intensive rehabilitation, cognitive behavioral therapy, Oswestry Disability Index, disability, walking capacity, SF-36
- MeSH terms
- Adolescent, Adult, Chronic Disease, Female, Humans, Male, Middle Aged, Patient Compliance, Spinal Fusion, Cognitive Behavioral Therapy, Treatment Outcome, Low Back Pain
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