Cited by 514Musculoskeletal pain and rehabilitationSpine and Intervertebral Disc PathologyPain Management and Treatment

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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

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Fairbank, Jeremy, Frost, Helen, Wilson-MacDonald, James, Yu, Ly-Mee, Barker, Karen, Collins, Rory·2005·BMJ

DOI 10.1136/bmj.38441.620417.8fPMC PMC558090

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Abstract

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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The Oswestry Disability Index
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Competing interests: none declared.
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Nuffield Orthopaedic Centre, Oxford OX3 7LD Jeremy Fairbank consultant orthopaedic surgeon James Wilson-MacDonald consultant orthopaedic surgeon Karen Barker director of physiotherapy research University of Warwick, Division of Health in the Community, Coventry CV4 7AL Helen Frost research fellow Centre for Statistics in Medicine, Oxford OX3 7LF Ly-Mee Yu statistician Clinical Trial Service Unit and Epidemiological Studies Unit, Radcliffe Infirmary, Oxford OX2 6HE Rory Collins professor Correspondence to: J Fairbank jeremy.fairbank@ndos.ox.ac.uk

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Background
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“In contrast, other studies evaluating individuals with symptomatic lumbar degenerative disease have reported that instrumented fusion resulted in minimal clinical improvements relative to conservative therapies, leading these authors to conclude that the marginal benefits obtained with this intervention did not warran…”
Result
Physical therapy for low back pain
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“Ours is an analysis of prospectively collected data; however, a randomized study would be desirable for comparing the outcomes with other gold standard interventions, that is, structured physiotherapy rehabilitation program or microdiscectomy or even placebo.(24)”
Result
Surgical Treatment of Degenerative Disk Disease in Three Scandinavian Countries: An International Register Study Based on Three Merged National Spine Registers
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Result
On total disc replacement
Berg, S. (2011) · Acta Orthopaedica · doi:10.3109/17453674.2011.575327 · Cited by 13
Quality and Quantity of Published Studies Evaluating Lumbar Fusion during the past 10 Years: A Systematic Review
Hart, R. A., Hermsmeyer, J. T., Sethi, R. K., & Norvell, D. C. (2015) · Global Spine Journal · doi:10.1055/s-0035-1552984 · Cited by 13
Psychosocial Interventions for Chronic Pain
Roy, R. G. (2008) · Springer eBooks · doi:10.1007/978-0-387-76296-8 · Cited by 16
Surgery versus intensive rehabilitation programmes for chronic low back pain
Koes, B. W. (2005) · BMJ · doi:10.1136/bmj.330.7502.1220 · Cited by 13
The challenges of translating the results of randomized controlled trials in orthopaedic surgery into clinical practice
Robinson, A. H. N., Johnson-Lynn, S. E., Humphrey, J. A., & Haddad, F. S. (2019) · The Bone & Joint Journal · doi:10.1302/0301-620x.101b2.bjj-2018-1352.r1 · Cited by 13
Low Back Pain
Cashin, A. G., Chou, R., Weimer, M. B., & McAuley, J. H. (2026) · JAMA · doi:10.1001/jama.2026.9631 · Cited by 14
Two Surgeries Do Not Always Make a Right: Spinal Cord Stimulation for Failed Back Surgery Syndrome.
Duy, P. Q., & Anderson, W. S. (2018) · Europe PMC (PubMed Central) · Cited by 12
Does low-back pain improve after decompressive spinal surgery? A prospective observational study from the British Spine Registry
Knight, J., Rangnekar, R., Richardson, D., McIlroy, S., Bell, D., & Ahmed, A. I. (2023) · Journal of Neurosurgery Spine · doi:10.3171/2023.5.spine23116 · Cited by 12
A Prospective, Randomized Study of Lumbar Fusion: Preliminary Results
Baker, A. D. L. (2013) · Springer eBooks · doi:10.1007/978-1-4471-5451-8_69 · Cited by 12
Interspinous spacers for lumbar foraminal stenosis: formal trials are justified
Hobart, J. C., Gilkes, C. E., Adams, W. M., & Germon, T. (2013) · European Spine Journal · doi:10.1007/s00586-012-2650-z · Cited by 12
Provocative diskography: safety and predictive value in the outcome of spinal fusion or pain intervention for chronic low-back pain
Willems, P. C. P. H. (2014) · Journal of Pain Research · doi:10.2147/jpr.s45615 · Cited by 12
Intradiskal Methylene Blue Treatment for Diskogenic Low Back Pain
Levi, D. S., Horn, S., & Walko, E. (2014) · PM&R · doi:10.1016/j.pmrj.2014.04.008 · Cited by 12
Spinal fusion achieves similar two-year improvement in HRQoL as total hip and total knee replacement. A prospective, multicentric and observational study
Cervera-Irimia, J., Tomé-Bermejo, F., Piñera, Á. R., Gallo, M. B., Bisaccia, M., Fernández-González, M., Villar-Pérez, J., Carreira, J. M. F., de Elizaga, J. O., Jiménez, F. J. A., et al. (2019) · SICOT-J · doi:10.1051/sicotj/2019027 · Cited by 12
The surgical treatment of disc degeneration: is the race not to the swift?
Carragee, E. J. (2005) · The Spine Journal · doi:10.1016/j.spinee.2005.09.007 · Cited by 12
Lumbar Disc Replacement Versus Interbody Fusion: Meta-analysis of Complications and Clinical Outcomes
Daher, M., Nassar, J. E., Balmaceno-Criss, M., Diebo, B. G., & Daniels, A. H. (2024) · Orthopedic Reviews · doi:10.52965/001c.116900 · Cited by 11
Anatomic Surgical Management of Chronic Low Back Pain
Chopko, B. W., Liu, J. C., & Khan, M. K. (2014) · Neuromodulation Technology at the Neural Interface · doi:10.1111/ner.12169 · Cited by 13
“The study conducted to support the investigational device exemption of the ProDisc-L demonstrated marginally superior results in visual analog scale, Oswestry Disability Index, and employment compared with circumferential fusion (47).”
Background
The Balanced Inventory for Spinal Disorders
Svensson, E., Schillberg, B., Kling, A., & Nyström, B. (2009) · Spine · doi:10.1097/brs.0b013e3181b07d6a · Cited by 11
Symptoms and signs possibly indicating segmental, discogenic pain. A fusion study with 18 years of follow-up
Nyström, B., Weber, H., Schillberg, B., & Taube, A. (2016) · Scandinavian Journal of Pain · doi:10.1016/j.sjpain.2016.10.007 · Cited by 11
Retrospectively Collected EQ-5D-5L Data as Valid Proxies for Imputing Missing Information in Longitudinal Studies
Rajan, S. S., Wang, M., Singh, N., Jacob, A. P., Parker, S. A., Czap, A. L., Bowry, R., Grotta, J. C., & Yamal, J. (2021) · Value in Health · doi:10.1016/j.jval.2021.07.007 · Cited by 10
Chronic pain rehabilitation in chronic headache disorders
Bruce, B. K., Townsend, C. O., Hooten, W. M., Rome, J. D., Moon, J. S., & Swanson, J. W. (2008) · Current Neurology and Neuroscience Reports · doi:10.1007/s11910-008-0016-z · Cited by 11
The pain experience and future expectations of chronic low back pain patients following spinal fusion
Bentsen, S. B., Rustøen, T., Wahl, A. K., & Miaskowski, C. A. (2008) · Journal of Clinical Nursing · doi:10.1111/j.1365-2702.2007.02234.x · Cited by 11
Predicting Back Pain Treatment Outcomes Among Workers’ Compensation Patients: Important Information for Clinical Neuropsychologists
Wheeler, A. J., Smith, A. L., Gundy, J. M., Sautter, T., & DeBerard, M. S. (2012) · The Clinical Neuropsychologist · doi:10.1080/13854046.2012.750686 · Cited by 10
“In another randomized multicenter trial there was no clear evidence that spinal fusion provided greater benefit than an intensive rehabilitation program based on cognitive behavioral therapy (Fairbank et al., 2005).”
Background
Spinal Fusion in the Treatment of Chronic Low Back Pain: Rationale for Improvement
Nyström, B. (2012) · The Open Orthopaedics Journal · doi:10.2174/1874325001206010478 · Cited by 10
Goal Achievement Model for Low Back Pain
Hazard, R. G. (2013) · Spine · doi:10.1097/brs.0b013e318299675e · Cited by 11
A pilot randomized controlled trial of virtual reality delivered relaxation for chronic low back pain
Rothbaum, A. O., Tannenbaum, L., Zimand, E., & ROTHBAUM, B. O. (2023) · Virtual Reality · doi:10.1007/s10055-023-00760-9 · Cited by 9
“The use of CBT in chronic pain has been demonstrated in trials comparing the efficacy of CBT to lumbar spine fusion surgeries, finding no significant differences, with clinical efficacy results maintained at one and two year follow-up (Brox et al. 2003, 2006; Fairbank et al. 2005).”
Method
Duloxetine Use in Chronic Low Back Pain
Ivanova, J. I., Birnbaum, H. G., Kantor, E., Schiller, M., & Swindle, R. W. (2012) · PharmacoEconomics · doi:10.2165/11598130-000000000-00000 · Cited by 9
“the patient has suffered functional disability longer than 6months; has failed a lengthy period of nonsurgical treatment; and has serious pathology, instability or neurological compression).([8-13]) A number of non-surgical treatments are available to patients with acute LBP and CLBP.”
Background
Predictors of Surgical Outcome
Mannion, A. F., & Elfering, A. (2008) · Springer eBooks · doi:10.1007/978-3-540-69091-7_7 · Cited by 9
Laminectomy and Extension of Instrumented Fusion Improves 2-Year Pain, Disability, and Quality of Life in Patients with Adjacent Segment Disease: Defining the Long-Term Effectiveness of Surgery
Adogwa, O., Park, P., Mendenhall, S. K., Shau, D. N., Aaronson, O. S., Cheng, J. S., Devin, C. J., & McGirt, M. J. (2011) · World Neurosurgery · doi:10.1016/j.wneu.2011.12.082 · Cited by 9
“Patient-assessed questionnaires included Visual Analog Scale for low back pain (VAS-BP) (10, 16) and leg pain (VAS-LP) (12, 14), low backe specific Oswestry Disability Index (ODI) (8, 9), Short Forme12 (SF-12) physical component score (PCS) and EuroQuol 5D (EQ-5D) (2, 14) quality of life.”
BackgroundInfluential
Evidence-based medicine: raising the bar
Glassman, S. D., & Branch, C. L. (2007) · The Spine Journal · doi:10.1016/j.spinee.2007.04.011 · Cited by 9
Thoughts and concerns of patients at hospital discharge after lumbar spine surgery. A qualitative study
Ferrari, S., Cedraschi, C., Mapelli, N., Baram, A., Costa, F., Gatti, R., & Fornari, M. (2023) · Disability and Rehabilitation · doi:10.1080/09638288.2022.2148761 · Cited by 8
“These findings in patients requiring surgery for low back pain are in line with other studies [32–34].”
Result
Cost and Utilization Trends of Lumbar Fusion
Martin, B. I., Mirza, S. K., Karamian, B. A., Schoenfeld, A. J., Ko, H., Suri, P., & Brodke, D. S. (2026) · JAMA Network Open · doi:10.1001/jamanetworkopen.2026.0452 · Cited by 8
Uninstrumented Posterior Lumbar Interbody Fusion: Have Technological Advances in Stabilizing the Lumbar Spine Truly Improved Outcomes?
Prolo, L. M., Oklund, S. A., Zawadzki, N. K., Desai, M., & Prolo, D. J. (2018) · World Neurosurgery · doi:10.1016/j.wneu.2018.03.210 · Cited by 8
Outcome of group physical therapy treatment for non-specific low back pain patients can be predicted with the cross-culturally adapted and validated Hungarian version STarT back screening tool
Szita, J., Kiss, L., Biczó, Á., Feher, K., Varga, P. P., & Lazáry, Á. (2020) · Disability and Rehabilitation · doi:10.1080/09638288.2020.1799248 · Cited by 8
“The baseline clinical features of the study group compared to other publications, and mostly surgically treated low back pain patients, the level of functional disability is relatively low [33,34].”
Result
Spinal fusion for single-level SPECT/CT positive lumbar degenerative disc disease: the SPINUS I study
Kaiser, R., Varga, M., Lang, O., Waldauf, P., Vaněk, P., Saur, K., Beneš, V., & Netuka, D. (2023) · Acta Neurochirurgica · doi:10.1007/s00701-023-05666-8 · Cited by 8
Comprehensive Pain Programs: A Treatment Approach Worth Validating
Bruehl, S. P. (2006) · Journal of Pain · doi:10.1016/j.jpain.2006.09.013 · Cited by 8
Local soft tissue musculoskeletal disorders and injuries. The role of physical and rehabilitation medicine physicians. The European perspective based on the best evidence. A paper by the UEMS-PRM Section Professional Practice Committee.
Oral, A., Ilieva, E. M., Küçükdeveci, A. A., Varela, E., Valero, R., Berteanu, M., & Christodoulou, N. (2013) · PubMed · Cited by 8

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
ORCID: Fairbank, Jeremy
Frost, Helen
Yu, Ly-Mee
Barker, Karen
Collins, Rory
Venue: BMJ
Publisher: BMJ
Published: 2005-05-23
Volume: 330
Issue: 7502
Pages: 1233
ISSN: 0007-1447 (ISSN-L)
0959-8138
1468-5833
DOI: 10.1136/bmj.38441.620417.8f
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
Licence: www.bmj.org/licenses/tdm/1.0/terms-and-conditions.html (tdm)
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 › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Musculoskeletal pain and rehabilitation
Health Sciences › Medicine › Orthopedics and Sports 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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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

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