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Cited by 116Spine and Intervertebral Disc PathologyMusculoskeletal pain and rehabilitationCervical and Thoracic Myelopathy

Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study

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Hellum, C., Johnsen, L. G., Storheim, K., Nygaard, O. P., Brox, J. I., Rossvoll, I., Ro, M., Sandvik, L. +2 more·2011·BMJ
DOI 10.1136/bmj.d2786PMC PMC3100911
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Abstract

OBJECTIVE: To compare the efficacy of surgery with disc prosthesis versus non-surgical treatment for patients with chronic low back pain. DESIGN: A prospective randomised multicentre study. SETTING: Five university hospitals in Norway. PARTICIPANTS: 173 patients with a history of low back pain for at least one year, Oswestry disability index of at least 30 points, and degenerative changes in one or two lower lumbar spine levels (86 patients randomised to surgery). Patients were treated from April 2004 to September 2007. INTERVENTIONS: Surgery with disc prosthesis or outpatient multidisciplinary rehabilitation for 12-15 days. MAIN OUTCOME MEASURES: The primary outcome measure was the score on the Oswestry disability index after two years. Secondary outcome measures were low back pain, satisfaction with life (SF-36 and EuroQol EQ-5D), Hopkins symptom check list (HSCL-25), fear avoidance beliefs (FABQ), self efficacy beliefs for pain, work status, and patients' satisfaction and drug use. A blinded independent observer evaluated scores on the back performance scale and Prolo scale at two year follow-up. RESULTS: The study was powered to detect a difference of 10 points on the Oswestry disability index between the groups at two years. At two years there was a mean difference of -8.4 points (95% confidence interval -13.2 to -3.6) in favour of surgery. In the analysis of prespecified secondary outcomes, there were significant differences in favour of surgery for low back pain (mean difference -12.2, -21.3 to -3.1), patients' satisfaction (63% (n = 46) v 39% (n = 26)), SF-36 physical component score (mean difference 5.8, 2.5 to 9.1), self efficacy for pain (mean difference 1.0, 0.2 to 1.9), and the Prolo scale (mean difference 0.9, 0.1 to 1.6). There were no significant differences in return to work, SF-36 mental component score, EQ-5D, fear avoidance beliefs, Hopkins symptom check list, drug use, and the back performance scale. One serious complication of leg amputation occurred during surgical revision of a polyethylene dislodgement. The drop-out rate was 20% (34) and the crossover rate was 6% (5). CONCLUSIONS: Surgical intervention with disc prosthesis for chronic low back pain resulted in a significantly greater improvement in the Oswestry score compared with rehabilitation, but this improvement did not clearly exceed the prespecified minimally important clinical difference between groups of 10 points, and the data are consistent with a wide range of differences between the groups, including values well below 10 points. The potential risks of surgery and the substantial amount of improvement experienced by a sizeable proportion of the rehabilitation group also have to be incorporated into overall decision making. Trial registration NCT 00394732.

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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 Hellum 2011

  • 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 Hellum 2011

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Authors
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
Affiliations
  • Oslo University Hospital (NO)
  • St Olav's University Hospital (NO)
Corresponding author
Hellum, C.
ORCID
Venue
BMJ
Publisher
BMJ
Published
2011-05-19
Volume
342
Issue
may19 2
Pages
d2786-d2786
ISSN
  • 0007-1447 (ISSN-L)
  • 0959-8138
  • 1468-5833
DOI
10.1136/bmj.d2786
PMC
PMC3100911
OpenAlex
W2056626132
Cited by
116
References
58
Citations by year
2025: 1 · 2024: 2 · 2023: 2 · 2022: 11 · 2021: 5 · 2020: 3 · 2019: 6 · 2018: 9 · 2017: 13 · 2016: 5 · 2015: 16 · 2014: 8 · 2013: 15 · 2012: 8
FWCI
9.65
Type
journal article
Language
en
Open access
Licence
cc-by-nc
Locations
  • BMJ (publishedVersion, cc-by-nc)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • HighWire Press Open Archive (submittedVersion)
Funders
EkstraStiftelsen Helse og Rehabilitering (Stiftelsen Dam)
Topics
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Spine and Intervertebral Disc Pathology
  • Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
  • Health Sciences › Medicine › Surgery › Cervical and Thoracic Myelopathy
Keywords
low back pain, intervertebral disc degeneration, lumbar disc prosthesis, lumbar disc arthroplasty, multidisciplinary rehabilitation, conservative treatment, Oswestry Disability Index, patient satisfaction, fear-avoidance beliefs, self-efficacy, return to work, quality of life, long-term outcomes, two-year follow-up
MeSH terms
Adult, Chronic Disease, Humans, Intervertebral Disc, Lumbar Vertebrae, Middle Aged, Prospective Studies, Treatment Outcome, Patient Satisfaction, Low Back Pain, Prosthesis Implantation, Young Adult, Intervertebral Disc Degeneration

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