Evidence map›Paper›PMID 12973134›Full record

Trial reportSpine2003

Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration.

Jens Ivar Brox, Roger Sørensen, Astrid Friis, Øystein Nygaard, Aage Indahl, Anne Keller, Tor Ingebrigtsen, Hege R Eriksen, Inger Holm, Anne Kathrine Koller and 2 more

3 registry-linked trialsOpen access · greenAbstract readClinical TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Spine, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 140 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
140citing papers in PubMed, 18 pooled it
21.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01055574 terminatednot on this mapstarted 2009, after this paper: background citation

Physical Capability Outcomes After Single-Level ProDisc-L Total Disc Replacement or Single-Level Anterior Lumbar Interbody Fusion: a Multi-Center Clinical Trial

TypeobservationalSponsorGundersen Lutheran Medical FoundationRan2009 to 2012Enrolled45ConditionsPhysical Capability Outcomes
NCT05466110 naunknown statusnot on this mapstarted 2023, after this paper: background citation

sPinal coRd stimulatiOn coMpared With Lumbar InStrumEntation for Low Back Pain After Previous Lumbar Decompression (PROMISE): a Prospective Randomized Controlled Study

TypeinterventionalSponsorUniversity Hospital AugsburgRan2023 to 2025Enrolled84ConditionsFailed Back Surgery Syndrome, SCS, Neuromodulation, Spinal Cord StimulationArmsSpinal Cord Stimulation, Spinal Fusion Surgery
NCT06169488 narecruitingnot on this mapstarted 2024, after this paper: background citation

The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial

TypeinterventionalSponsorOslo University HospitalRan2024 to 2030Enrolled202ConditionsChronic Low-back PainArmsLumbar Interbody Fusion, Multidisciplinary rehabilitation
3 · Its place in the literature

Who cites it

140 citing papers in PubMed, 18 syntheses or guidelines pooled it, 620 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Motor control exercise for acute non-specific low back pain.The Cochrane database of systematic reviews · 2016
    Pooled it
  5. Motor control exercise for chronic non-specific low-back pain.The Cochrane database of systematic reviews · 2016
    Pooled it
  6. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain.The Cochrane database of systematic reviews · 2014
    Pooled it
  7. Rehabilitation following surgery for lumbar spinal stenosis.The Cochrane database of systematic reviews · 2013
    Pooled it
  8. Pooled it
  9. Pooled it
  10. Low back pain (chronic).BMJ clinical evidence · 2010
    Pooled it
  11. Behavioural treatment for chronic low-back pain.The Cochrane database of systematic reviews · 2010
    Pooled it
  12. Pooled it
  13. Pooled it
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  15. Health economic evaluation in lumbar spinal fusion: a systematic literature review anno 2005.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2006
    Pooled it
  16. Methodological aspects of outcomes research.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2006
    Pooled it
  17. Surgery for degenerative lumbar spondylosis.The Cochrane database of systematic reviews · 2005
    Pooled it
  18. Evidence-informed management of chronic low back pain with cognitive behavioral therapy.The spine journal : official journal of the North American Spine Society
    Pooled it
  19. Trial
  20. Trial

80 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 3 countries.

Jens Ivar BroxDepartment of Orthopedic Surgery, National Hospital, Oslo, Norway. jens.ivar.brox@rikshospitalet.no
Roger Sørensen
Astrid Friis
Øystein Nygaard
Aage Indahl
Anne Keller
Tor Ingebrigtsen
Hege R Eriksen
Inger Holm
Anne Kathrine Koller
Rolf Riise
Olav Reikerås
National Hospital · INGold Coast Hospital · AUOslo University Hospital · NOSt Olav's University Hospital · NOUniversity Hospital of North Norway · NOUniversity of Bergen · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designSingle blind randomized study.

objectivesTo compare the effectiveness of lumbar instrumented fusion with cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. SUMMARY OF BACKGROUND DATA: To the authors' best knowledge, only one randomized study has evaluated the effectiveness of lumbar fusion. The Swedish Lumbar Spine Study reported that lumbar fusion was better than continuing physiotherapy and care by the family physician. PATIENTS AND

methodsSixty-four patients aged 25-60 years with low back pain lasting longer than 1 year and evidence of disc degeneration at L4-L5 and/or L5-S1 at radiographic examination were randomized to either lumbar fusion with posterior transpedicular screws and postoperative physiotherapy, or cognitive intervention and exercises. The cognitive intervention consisted of a lecture to give the patient an understanding that ordinary physical activity would not harm the disc and a recommendation to use the back and bend it. This was reinforced by three daily physical exercise sessions for 3 weeks. The main outcome measure was the Oswestry Disability Index.

resultsAt the 1-year follow-up visit, 97% of the patients, including 6 patients who had either not attended treatment or changed groups, were examined. The Oswestry Disability Index was significantly reduced from 41 to 26 after surgery, compared with 42 to 30 after cognitive intervention and exercises. The mean difference between groups was 2.3 (-6.7 to 11.4) (P = 0.33). Improvements inback pain, use of analgesics, emotional distress, life satisfaction, and return to work were not different. Fear-avoidance beliefs and fingertip-floor distance were reduced more after nonoperative treatment, and lower limb pain was reduced more after surgery. The success rate according to an independent observer was 70% after surgery and 76% after cognitive intervention and exercises. The early complication rate in the surgical group was 18%.

conclusionThe main outcome measure showed equal improvement in patients with chronic low back pain and disc degeneration randomized to cognitive intervention and exercises, or lumbar fusion.

Indexed as

AdultChronic DiseaseCognitive Behavioral TherapyExercise TherapyFemaleFollow-Up StudiesHumansIntervertebral Disc DisplacementLow Back PainLumbar VertebraeMaleMiddle AgedPatient ComplianceSingle-Blind MethodSpinal FusionTreatment Outcome

Identifiers

PMID12973134
OpenAlexW2111209536

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.