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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“…al. 2007 No Yes No No Yes Yes Yes No No No El Rassi et al. 2005 No No No No Yes Yes Yes No No Yes Faas et al. 1995 No Yes No Yes Yes Yes No No No No Fairbank et al. 2005 No Yes Yes No Yes Yes Yes No No No Ferreira et al. 2007 No Yes Yes No Yes Yes Yes No No No Frost et al. 1998 No Yes Yes Yes Yes…”
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Background
Quality of Life in Patients Undergoing Spine Surgery: Systematic Review and Meta-Analysis
Nayak, N. R., Stephen, J. H., Piazza, M. A., Obayemi, A. A., Stein, S. C., & Malhotra, N. R. (2018) · Global Spine Journal · doi:10.1177/2192568217701104 · Cited by 35
Lumbar fusion compared with conservative treatment in patients with chronic low back pain
Saltychev, M., Eskola, M., & Laimi, K. (2013) · International Journal of Rehabilitation Research · doi:10.1097/mrr.0b013e328363ba4b · Cited by 35
“Of these five studies, four had also been included in previous reviews (Fritzell et al., 2001; Brox et al., 2003, 2006; Fairbank et al., 2005).”
BackgroundMethodResultInfluential
Quality of life in chronic low back pain patients treated with instrumented fusion
Bentsen, S. B., Hanestad, B. R., Rustøen, T., & Wahl, A. K. (2008) · Journal of Clinical Nursing · doi:10.1111/j.1365-2702.2008.02232.x · Cited by 35
“…of life is common for patients suffering from chronic low back pain (CLBP) and the goal of treatment is to optimise patients’ quality of life in terms of less pain and better functioning (Boden et al. 2000, Glassman et al. 1998, Kleeman et al. 2001, Beurskens et al. 1995, Fairbank et al., 2005).”
BackgroundResult
The Pros and Cons of Evidence-Based Medicine
Croft, P. R., Malmivaara, A. V., & van Tulder, M. W. (2011) · Spine · doi:10.1097/brs.0b013e318223ae4c · Cited by 34
Surgical versus Nonsurgical Treatment
(2011) · Thieme eBooks · doi:10.1055/b-0034-67118 · Cited by 34
Meta-analysis of randomized trials comparing fusion surgery to non-surgical treatment for discogenic chronic low back pain
Wang, X., Wanyan, P., Tian, J. H., & Hu, L. (2015) · Journal of Back and Musculoskeletal Rehabilitation · doi:10.3233/bmr-140571 · Cited by 33
Developing Modern Pain Therapies
Manion, J., Waller, M. A., Clark, T., Massingham, J. N., & Neely, G. G. (2019) · Frontiers in Neuroscience · doi:10.3389/fnins.2019.01370 · Cited by 35
Back Pain
Gibbs, D. L., McGahan, B. G., Ropper, A. E., & Xu, D. S. (2022) · Neurologic Clinics · doi:10.1016/j.ncl.2022.07.002 · Cited by 39
Registers needed for new interventional procedures
Lyratzopoulos, G., Patrick, H. E., & Campbell, B. K. (2008) · The Lancet · doi:10.1016/s0140-6736(08)60742-4 · Cited by 33
Are physiotherapy exercises effective in reducing chronic low back pain?
Lewis, A., Morris, M. E., & Walsh, C. (2008) · Physical Therapy Reviews · doi:10.1179/174328808x252000 · Cited by 33
Clinical decision making in spinal fusion for chronic low back pain. Results of a nationwide survey among spine surgeons
Willems, P. C. P. H., de Bie, R. A., Öner, F. C., Castelein, R. M., & de Kleuver, M. (2011) · BMJ Open · doi:10.1136/bmjopen-2011-000391 · Cited by 33
“Similarly, in the more recent British spine stabilisation trial, no clear evidence was found that spinal fusion was more beneficial than an intensive rehabilitation programme at 2-year follow-up.(11) Moreover, fusion had a much higher complication rate in this trial and appeared to be less cost-effective than intensiv…”
Result
Letters
Fairbank, J. C. T. (2007) · Spine · doi:10.1097/brs.0b013e31815b84ca · Cited by 33
What is the Role of Epidural Injections in the Treatment of Lumbar Discogenic Pain: A Systematic Review of Comparative Analysis with Fusion
Manchikanti, L., Staats, P. S., Nampiaparampil, D. E., & Hirsch, J. A. (2015) · The Korean journal of pain · doi:10.3344/kjp.2015.28.2.75 · Cited by 34
“[50] with 28%, whereas all studies had a proportion of patients who did not receive the treatment they were originally entitled to.”
BackgroundMethodInfluential
Labor Force Participation and the Influence of Having Back Problems on Income Poverty in Australia
SCHOFIELD, D. J., Callander, E. J., Shrestha, R. N., Percival, R., Kelly, S., & Passey, M. E. (2011) · Spine · doi:10.1097/brs.0b013e31824481ee · Cited by 32
Bone morphogenic protein-2 signaling in human disc degeneration and correlation to the Pfirrmann MRI grading system
Hollenberg, A. M., Maqsoodi, N., Phan, A. T., Huber, A., Jubril, A., Baldwin, A. L., Yokogawa, N., Eliseev, R. A., & Mesfin, A. (2021) · The Spine Journal · doi:10.1016/j.spinee.2021.03.002 · Cited by 33
Clinical evaluation and surgical decision making for patients with lumbar discogenic pain and facet syndrome
Tessitore, E., Molliqaj, G., Schatlo, B., & Schaller, K. (2014) · European Journal of Radiology · doi:10.1016/j.ejrad.2014.03.016 · Cited by 32
Role of Single-Photon Emission Computed Tomography Imaging in the Diagnosis and Treatment of Chronic Neck or Back Pain Caused by Spinal Degeneration: A Systematic Review
Varga, M., Kantorová, L., Langaufová, A., Štulík, J., Lancova, L., Srikandarajah, N., & Kaiser, R. (2023) · World Neurosurgery · doi:10.1016/j.wneu.2023.02.058 · Cited by 31
Age and pro-inflammatory gene polymorphisms influence adjacent segment disc degeneration more than fusion does in patients treated for chronic low back pain
Omair, A., Mannion, A. F., Holden, M., Leivseth, G., Fairbank, J. C. T., Hägg, O., Fritzell, P., & Brox, J. I. (2015) · European Spine Journal · doi:10.1007/s00586-015-4181-x · Cited by 31
“The specific interventions used in the respective centres are given in the original studies (Norway [16, 17], UK [18], Eur Spine J (2016) 25:2–13 3”
Method
The role of clinical specialist Physiotherapists in the management of low back pain in a Spinal Triage Clinic
Murphy, S., Blake, C. M., Power, C. K., & Fullen, B. M. (2013) · Irish Journal of Medical Science (1971 -) · doi:10.1007/s11845-013-0945-7 · Cited by 31
Current concepts in intradiscal percutaneous minimally invasive procedures for chronic low back pain
Gelalis, I. D., Gkiatas, I. S., Spiliotis, A. E., Papadopoulos, D., Pakos, E. E., Vekris, M. D., & Korompilias, A. V. (2018) · Asian Journal of Neurosurgery · doi:10.4103/ajns.ajns_119_17 · Cited by 31
“In the UK Medical Research Council trial,[107] spinal fusion was compared to an intensive program of exercise therapy, spine stabilization exercises, and education using cognitive‐behavioral principals.”
Method
Cervical and Lumbar Spinal Arthroplasty: Clinical Review
Uschold, T. D., Fusco, D., Germain, R. S., Tumialán, L. M., & Chang, S. W. (2011) · American Journal of Neuroradiology · doi:10.3174/ajnr.a2758 · Cited by 30
“The concept of lumbar disk replacement as an alternative to fusion initially gained momentum following the success of total knee and hip arthroplasty.(74,75) Since the first described total disk replacement in the late 1950s,(7) multiple disk replacement prostheses have been designed for use in the lumbar spine.”
Background
Association Between Opioid Use and Patient-Reported Outcomes in a Randomized Trial Evaluating Basivertebral Nerve Ablation for the Relief of Chronic Low Back Pain
Markman, J. D., Rhyne, A. L., Sasso, R. C., Patel, A. A., Hsu, W. K., Fischgrund, J. S., Edidin, A. A., & Vajkoczy, P. (2019) · Neurosurgery · doi:10.1093/neuros/nyz093 · Cited by 30
Total disc replacement versus multidisciplinary rehabilitation in patients with chronic low back pain and degenerative discs: 8-year follow-up of a randomized controlled multicenter trial
Furunes, H., Storheim, K., Brox, J. I., Johnsen, L. G., Skouen, J. S., Franssen, E., Solberg, T. K., Sandvik, L., & Hellum, C. (2017) · The Spine Journal · doi:10.1016/j.spinee.2017.05.011 · Cited by 30
Patient-centered evaluation of outcomes from rehabilitation for chronic disabling spinal disorders: the impact of personal goal achievement on patient satisfaction
Hazard, R. G., Spratt, K. F., McDonough, C. M., Olson, C. M., Ossen, E. S., Hartmann, E. M., Carlson, R. J., & LaVoie, J. (2012) · The Spine Journal · doi:10.1016/j.spinee.2012.09.003 · Cited by 29
A novel classification system of lumbar disc degeneration
Riesenburger, R. I., Safain, M. G., Ogbuji, R., Hayes, J., & Hwang, S. W.-H. (2014) · Journal of Clinical Neuroscience · doi:10.1016/j.jocn.2014.05.052 · Cited by 29
“Most experts cite only four high quality prospective outcomes studies in the literature that investigate the utility of lumbar fusion for the treatment of low back pain [10–13].”
BackgroundInfluential
Evaluation of current surgeon practice for patients undergoing lumbar spinal fusion surgery in the United Kingdom
Rushton, A. B., White, L. J., Heap, A., & Heneghan, N. R. (2015) · World Journal of Orthopedics · doi:10.5312/wjo.v6.i6.483 · Cited by 28
Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma)): study protocol for a randomized controlled trial
GREGSON, B. A., Rowan, E. N., Mitchell, P., Unterberg, A., McColl, E., Chambers, I., McNamee, P., & Mendelow, A. D. (2012) · Trials · doi:10.1186/1745-6215-13-193 · Cited by 28
Effective Conservative Treatment for Chronic Low Back Pain
Rainville, J., Nguyen, R. T., & Suri, P. (2009) · Seminars in Spine Surgery · doi:10.1053/j.semss.2009.08.009 · Cited by 29
“In 2005, Fairbank et al published the second RCT comparing lumbar stabilization surgery and intensive rehabilitation for the treatment of chronic low back pain (2) (Table 3).”
BackgroundInfluential
Anxiety Levels, Fear‐avoidance Beliefs, and Disability Levels at Baseline and at 1 Year among Subjects with Acute and Chronic Low Back Pain
Newcomer, K. L., Shelerud, R. A., Douglas, K. S. V., Larson, D. R., & Crawford, B. J. (2010) · PM&R · doi:10.1016/j.pmrj.2010.03.034 · Cited by 28
The MRC Spine Stabilization Trial
Wilson-MacDonald, J., Fairbank, J. C. T., Frost, H., Yu, L., Barker, K. L., Collins, R., & Campbell, H. (2008) · Spine · doi:10.1097/brs.0b013e318186a8b2 · Cited by 28
Clinical Outcomes of Total Disc Replacement Versus Anterior Lumbar Interbody Fusion for Surgical Treatment of Lumbar Degenerative Disc Disease
Mattei, T. A., Beer, J., Teles, A. R., Rehman, A. A., Aldag, J. C., & Dinh, D. H. (2017) · Global Spine Journal · doi:10.1177/2192568217712714 · Cited by 27
Effectiveness of self-management of dry and wet cupping therapy for low back pain: A systematic review and meta-analysis
Shen, W.-C., Jan, Y., Liau, B.-Y., Lin, Q., Wang, S., Tai, C., & Lung, C.-W. (2022) · Medicine · doi:10.1097/md.0000000000032325 · Cited by 27
“[9] However, rehabilitation is not routinely or widely available to patients with chronic pain of the LBP because rehabilitation programs require finance, space, and clinician-involved training.[12] In the third-line treatment, surgery is reliable when the pain is not tolerable.”
Background
The effect of timing of rehabilitation on physical performance after lumbar spinal fusion: a randomized clinical study
Oestergaard, L. G., Nielsen, C. V., Bünger, C. E., Svidt, K., & Christensen, F. B. (2013) · European Spine Journal · doi:10.1007/s00586-013-2717-5 · Cited by 27
Degenerative Lumbar Scoliosis
Koerner, J. D., Reitman, C. A., Arnold, P. M., & Rihn, J. A. (2015) · JBJS Reviews · doi:10.2106/jbjs.rvw.n.00061 · Cited by 27
Commentary: Folly of FDA-approval studies for bone morphogenetic protein
Mirza, S. K. (2011) · The Spine Journal · doi:10.1016/j.spinee.2011.05.009 · Cited by 27
“2005 (BMJ) [19] 45 (15) 36 (21) 46 (15) 34 (21) Fritzell et al.”
BackgroundMethodInfluential
Surgery for chronic musculoskeletal pain: the question of evidence
Harris, I. A., Sidhu, V. S., Mittal, R., & Adie, S. (2020) · Pain · doi:10.1097/j.pain.0000000000001881 · Cited by 26
Exercise in the management of chronic back pain.
Dreisinger, T. E. (2014) · Europe PMC (PubMed Central) · Cited by 26
Letters
Saltychev, M., & Laimi, K. (2014) · Spine · doi:10.1097/brs.0000000000000278 · Cited by 26
Description and design considerations of a randomized clinical trial investigating the effect of a multidisciplinary cognitive-behavioural intervention for patients undergoing lumbar spinal fusion surgery
Rolving, N., Oestergaard, L. G., Willert, M. V., Christensen, F. B., Blumensaat, F., Bünger, C. E., & Nielsen, C. V. (2014) · BMC Musculoskeletal Disorders · doi:10.1186/1471-2474-15-62 · Cited by 25
“Modifying these traits, and thereby improving pain levels, disability and quality of life, seems to be achievable through the application of CBT [13,19-21].”
Background
The surgical treatment of non-specific low back pain
Todd, N. V. (2017) · The Bone & Joint Journal · doi:10.1302/0301-620x.99b8.bjj-2017-0199.r1 · Cited by 25
Laminectomy for lumbar canal stenosis: a safe and effective treatment
Wilby, M. J., Seeley, H. M., & Laing, R. J. C. (2006) · British Journal of Neurosurgery · doi:10.1080/02688690601048195 · Cited by 25

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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