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Current Standard of Care

Back pain is the second most common reason for visits to the doctor’s office in the U.S., with lower back pain afflicting 60-80% of adults in their lifetime.1 When evaluating back and neck pain patients, clinicians use a combination of MRI, neutral x-rays, and x-rays taken at the end-range of trunk bending—the latter to evaluate spine motion.

Current Standard of Care fig 1

End-range x-ray process: By comparing the two films taken at the extremes of bending, the relative change in position between two vertebrae is manually measured (protractor and ruler). The range of motion is then expressed as the resulting intervertebral angle (IVA).

Current Standard of Care fig 2

Problems with End-range X-rays

The end-range x-ray method was first described in the 1940s2 and remains the most widely used method of measuring the motion between vertebrae. However, the usefulness of this method has been debunked by multiple studies.3-8 In fact, in one publication, the authors noted that “…using clinical flexion-extension roentgenograms as a basis for diagnosing instability can lead to serious errors in classification”.7 The literature points to two major problems with end-range x-rays:

Problem #1: Unreliable Measurement

High variability makes the numeric output unreliable and practically useless.

Unreliable Measurement
Problem #2: Not a True Functional Test

Two static x-ray images of the spine do not reflect the complexities of spine motion.

Weak link in back pain diagnosis and treatment

Despite these problems, the end-range x-ray method is a fixture in evaluating back and neck pain patients, triggering diagnoses and treatments.

Diagnosis:

Only 15% of back pain patients get a definitive anatomic diagnosis using the current testing regime.9,10

Treatment:

Of the 400,000+ lumbar and cervical fusions per year in the U.S., over 90% are technically successful, but 60-70% are effective at relieving pain.1,11,12

This gap in fusion outcomes highlights a major opportunity for improvement in spine diagnostics.



  1. Frymoyer JW, Cats-Baril WL. An overview of the incidences and costs of low back pain. Orthop Clin North Am 1991;22:263-71
  2. Knutsson F. The Instability Associated with Disk Degeneration in the Lumbar Spine. Acta Radiol 1944;25:593-608
  3. Leone A, Guglielmi G, Cassar-Pullicino VN, Bonomo L. Lumbar intervertebral instability: a review. Radiology 2007;245(1):62-77
  4. Nizard RS, Wybier M, Laredo JD. Radiologic assessment of lumbar intervertebral instability and degenerative spondylolisthesis. Radiologic Clinics of North America 2001;39:55-71
  5. Dvorak J, Panjabi MM, Noventoy JE, Chang DG, Grob D: 1. Clinical Validation of Functional Flexion-Extension Roentgenograms of the Lumbar Spine. Spine 1991;16(8):943-950
  6. Boden SD, et. al. Lumbosacral segmental motion in normal individuals. Have we been measuring instability properly? Spine 1990;15(6):571-576
  7. Shaffer WO, Spratt KF, Weinstein J, Lehmann TR, Goel V. 1990 Volvo Award in clinical sciences. The consistency and accuracy of roentgenograms for measuring sagittal translation in the lumbar vertebral motion segment. An experimental model. Spine 1990;15(8):741-750
  8. Penning L, et. al. Inability to prove instability. A critical appraisal of clinical-radiological flexion-extension studies in lumbar disc degeneration. Diagn Imaging Clin Med. 1984;53(4):186- 192
  9. Murphy D, Hurwitz E. A theoretical model for the development of a diagnosis-based clinical decision rule for the management of patients with spinal pain. Musculoskeletal Disorders 2007; 8:75
  10. Waddell G. The Back Pain Revolution. Second Edition. New York: Churchill Livingstone, 2004
  11. Burkus JK, Zdeblick TA. Lumbar disc disease A. pathophysiology of lumbar spondylosis and discogenic back pain. In The Adult and Pediatric Spine. (Frymoyer JW, Wiesel SW, An HS, Boden SD, Lauerman WC eds). Lippincott Williams & Wilkins 2003:907
  12. Muggleton JM, Kondracki M, Allen R. Spinal fusion for lumbar instability: does it have a scientific basis? J Spinal Disord 2000;13:200-4

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