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Inappropriate Use of Videofluoroscopy

Stephen Barrett, M.D.

Videofluoroscopy is being promoted to medical doctors and chiropractors as a tool for diagnosing stretched spinal ligaments that "elude diagnosis on static x-ray and MRI." It is also being pitched to chiropractors as a way to prove that treatment was necessary, to document the presence of "subluxations," and to increase attorney referrals by qualifying the chiropractor as "an expert witness in the application, utilization and interpretation of Dynamic Motion X-Ray." [1] VF-Works, of Florida, states that its Dynamic Motion X-Ray system "rules out fraudulent 'soft tissue' claims, proves medical necessity, proves soft tissue injuries, objectively increases patient compliance, decreases costs, increases timely patient recovery [and] increases research grants." [2] VF-Works and its sister company Nu-Best Franchising sell their equipment mounted in a van that can service chiropractic offices [3].

The equipment can be purchased for use in the office or in specially equipped vans that travel from office to office. It produces and records x-ray pictures of the spinal joints that show the extent to which joint disfunction is impaired by adhesions and stretched or torn ligaments.

Unnecessary videofluoroscopy is a waste of money and exposes the patient to unnecessary radiation. To be clinically useful, a procedure must supply information that is clinically useful in patient management. In most cases, spinal instability can be adequately diagnosed from the patient's history and physical examination.

Even the American Chiropractic Association has expressed concern about inappropriate use of videofluoroscopy. In 1991, its House of Delegates passed a resolution stating (in part) that spinal videofluoroscopy:

In 1998, the FDA sent a "program disapproval letter" and a warning letter to VF-Works about its Visualizer 2000 Diagnostic X-Ray System. The disapproval letter stated that the company had not established appropriate quality control and certification procedures [4]. The warning letter concerned inadequate safety features [5]. During 1999, the FDA approved a correctional plan that required improving the collimator of 62 units and adding a timer to 25 units [6]. In July 2001, the FDA issued another warning that the company that the company was out of complisnce [7].

In January 2000, Dynamic Chiropractic published a report stating that most of 13 franchise-holders identified on the VF-Works Web site had not found their franchise profitable [8]. Two former franchise-holders have sued VF-Works and Nu-Best for allegedly making false representations about FDA approval [9].

References

  1. DMX and the doctor. Nu-Best Web site, accessed July 30, 2000.
  2. VF-Works Web site. Accessed May 30, 2000.
  3. Program disapproval lifted, "Class II Recall" required, new lawsuit filed. Dynamic Chiropractic, Jan 25, 2000.
  4. Gill LJ. Program disapproval letter to John R. Postlewaite, D.C., July 28, 1998.
  5. Tolen DD. Warning letter to John R. Postlewaite, D.C., Aug 9, 1998.
  6. FDA Enforcement Report, Oct 6, 1999.
  7. Singleton ER. Warning letter to John Postlewaite, D.C., July 20, 2001.
  8. Big problems for VF Works/Nu-Best franchising. Dynamic Chiropractic, March 8, 1999..
  9. Another lawsuit for VF-Works. Dynamic Chiropractic

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This article was revised on February 6, 2002.