Sep 02 2008
There was a full-page ad in my local paper today for Back in Action Spine and Health Centers, targeted at sufferers from almost any kind of chronic back pain. It started with “Are You Ready to Throw in the Towel and Just Live with Hurting So Bad?” It went on to make a number of claims:
- Doctors can fix the problem.
- Breakthrough medical technologies.
- Treatments are FDA cleared.
- Treatments are scientifically proven.
- No side effects.
- Best kept secrets for healing “bad backs.”
- Corrects scoliosis.
- Corrects compressed discs.
- Several university studies at Johns Hopkins, Stanford and Duke have confirmed that these treatments work.
- Medical researchers have reported these methods up to 89% effective.
- Treatments work for back and neck pain, sciatica/numbness, herniated and/or bulging discs, degenerative disc disease (arthritis), spinal stenosis, facet syndromes, spondylolisthesis.
- Their questionnaire can determine who will benefit – if you fit even one criterion like “does your back feel out of alignment?” or “do you have arthritis?” you should call right away.
The ad offers a “Free Qualifying Exam” but you “Must Not Wait” because appointments are limited and they can only honor this free offer for 3 weeks. To encourage you to call, they sweeten the pot with a FREE $49 gift bag.
Are you suspicious yet? You should be.
All the claims listed above are false. Ads like this are promoting a machine that promises nonsurgical spinal decompression (the DRX 9000 or a related device). These machines are not a breakthrough of any kind; they’re just a fancy technological gimmick for providing old-fashioned traction. The same traction that has been rejected by mainstream medicine because it does nothing to change the outcome and seldom even does anything to temporarily relieve symptoms. The FDA approval is a “grandfathered” 510(k) clearance that only says the new device is equivalent to older traction devices so it doesn’t require separate approval. The “doctors” are almost always chiropractors, and not identifying themselves as chiropractors is a direct violation of their own published ethics guidelines. Claims for effectiveness are based on junk science: case reports and uncontrolled, poor quality pilot studies usually funded by the manufacturer. There is NO acceptable evidence that these machines are effective, and a recent review article in the chiropractors’ own literature says as much. These treatments DO have side effects; they sometimes aggravate symptoms and can harm patients. They cannot “correct” ruptured discs and the FTC does not allow them to claim that they can.
Insurance and Medicare do not cover these treatments, and they usually end up costing the patient several thousand dollars out of pocket. They may provide temporary relief for a minority of patients, but the same results could be obtained far more cheaply by a physical therapist whose treatments are covered by insurance.
I’ve written about these machines before. An article I wrote in Skeptical Inquirer is available online at http://findarticles.com/p/articles/mi_m2843/is_5_31/ai_n27361167 It covers more details than I can include here. Some of what I found would be laugh-out-loud funny except that people are being misled, relieved of their money, and even physically harmed (there is at least one report that the machine caused a ruptured disc). For those who may not want to read that whole article, here’s an excerpt highlighting their inept advertising techniques and the abysmal quality of their evidence:
The report did not even give the correct reference for this essential study. It listed one of the two authors with all his titles (MD, JD, MBA, FICS, FRCS), misprinted one of his titles (“FICA” instead of FICS), omitted the name of the second author, gave the name of the journal incorrectly, misquoted the title of the article, and misprinted spinal as spinla. Another reference consisted of nothing but the name of a journal. The report was full of spelling errors, used loose for lose and included lexical gems like “it depends on your individually case.” A mistake or two in an individual doctor’s report would be excusable, but this report was prepared by a company with a product to sell. If carelessness about English and the facts extends to carelessness in manufacturing its machines, it may have a few loose screws–and not just in the machines.
Despite the faulty citation, I was able to find the study that the 86-percent claim was based on. It was easy to see why it wasn’t published in a reputable, peer-reviewed medical journal–it wouldn’t have passed review. There are so many things wrong with it that it can more rightly serve as an example of a bad study. A good study randomizes patients into treatment and control groups. This study had no control group, and its only randomization was that 229 subjects were “randomly” chosen from a pool of 500 with disk disease. The point of this escapes me. Part of the exam was a straight-leg-raising test: “… radiating pain into the lower back and leg was categorized when raising the leg over 30 degrees or less is considered positive, but if pain remained isolated in the lower back, it was considered negative.” [no, this doesn’t make sense, either grammatically or medically]…
Next I read that “Each session consisted of a 45-minute treatment on the equipment followed by 15 minutes of ice and interferential frequency therapy to consolidate the lumbar paravertebral muscles.” Sorry, but I don’t have any idea what it means to “consolidate” a muscle, and the “interferential frequency therapy” seems to be a kind of TENS (Transcutaneous Electrical Nerve Stimulation). TENS was shown to have zero effectiveness in another study (Sherry et al. 2001) cited by decompression advocates, so I fail to see why they used it here. The patients also were instructed to wear lumbar support belts, restrict activity, and take nonsteroidal drugs. You don’t suppose that any of those factors could have helped relieve their pain, do you? And how many of these patients might have had resolution of their symptoms without any treatment? The natural history of disk disease is that “The herniated portion of the disk visible on serial MRI studies tends to heal and regress with time. Partial or complete resolution of the herniated portion of the disk over 6 months may occur in as many as two thirds of patients” (Elder and Smucker 2006). And I don’t see how it can be claimed that this study supports using the DRX 9000, because nowhere in the study does it say what machine was used. I e-mailed the company and asked if they could verify that this was its machine. There was no reply.
I tried to track down the primary author of the study, Thomas Gionis. He has no studies on back pain listed in PubMed. He apparently has left medicine for law and was recently removed from his position as editor of a law review because he spent thirty months in jail on a felony assault conviction for hiring someone to beat up his ex-wife, the daughter of John Wayne, because of a custody dispute (“Law editor” 2001). In addition, he had lost his medical license and was trying to get it reinstated (Associated Press 2001). Somehow he does not inspire confidence as a medical authority.
On June 2, 2008, The Medical Letter evaluated spinal decompression machines, concluding:
There is no acceptable evidence that non-surgical spinal decompression machines can correct degenerated or herniated discs or that they relieve pain in patients with these conditions. There is also no convincing evidence that the physiological responses of lumbar tissue to power traction equipment are superior to those with standard mechanical traction.
After I wrote the Skeptical Inquirer article, I received e-mails from disappointed patients, from neurosurgeons and even from chiropractors, thanking me for exposing this scam. One of the chiropractors came right out and called the spinal decompression claims “lies” and said:
I can tell you exactly why they became such instant hits with the chiropractic community. Money. Within 6 months of the first time I had heard of a DRX 9000 I started seeing testimonials by chiropractors, in publications for chiropractors, touting the fact that they are clearing an additional $50,000 per month with this. Who doesn’t like the thought of an extra $600,000 income each year?
The manufacturers of the DRX 9000 are under siege: the FDA raided their headquarters and they’ve been sued and accused of false advertising, of injuring patients, and of instructing DRX 9000 clinic owners how to defraud insurance companies by submitting false billing codes. Perhaps this new, more veiled ad campaign is an attempt at damage control. For one thing, they’ve removed the claim that the machine is a “space age discovery” resulting from NASA research on astronauts (that was a total fabrication).
It is ironic that these machines are being used by chiropractors. Chiropractors, the self-proclaimed back experts, the ones who claim their adjustments are the answer to everything that ails you or at least to most musculoskeletal problems. Using these machines amounts to a confession that chiropractic adjustments are not so effective after all.
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